Medicine Archives - Page 2 of 3

Medicine

Atropos funding surge enhancing AI in healthcare

This funding surge comes as the company continues to advance the application of generative AI through its platform, Geneva OS. The investment round was spearheaded by Valtruis, with substantial contributions from Cencora Ventures, McKesson Ventures, and Merck Global Health Innovation Fund, in addition to the continued support of existing backers like Breyer Capital, Emerson Collective, […]

Medicine

Swixx Biopharma creating new breed of global pharma partners

It has achieved this with the acquisition of Pharma Consulting Group S.A., the holding company of Laboratorios Biopas SA. This move significantly extends and transforms Swixx BioPharma’s footprint, adding $220 million in sales, over 300 employees, and therapeutic coverage in neurology, oncology, immunology, gastroenterology, rare diseases, and specialty. The acquisition of Biopas is immediately accretive, […]

Medicine

Elinzanetant shows significant reduction in menopausal hot flashes

Detailed results from studies Oasis 1 and 2 will be showcased at the 2024 ACOG Annual Clinical & Scientific Meeting in San Francisco. The studies demonstrate that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, associated with menopause in women. This […]

Medicine

How has geopolitical tension created problems for life sciences?

She has a PharmD-PhD in Medical Physics and is a seasoned professional with a deep understanding of healthcare, law, and regulatory affairs. OSP was extremely keen to speak to Caroline and dig deep into a major talking point in the industry – the geopolitical tensions between the US and China and to find out everything […]

Medicine

Study digs deep on clinical trials to find out what sponsors want

The survey included 127 pharmaceutical sponsor respondents and 79 research site respondents, analyzing their perspectives working together on site feasibility questionnaires. OSP wanted to dig a little deeper into the findings so arranged to speak to Marcy Kravet, head of oncology strategy at Inato. What were the key motivations behind conducting this survey on site feasibility […]

Medicine

Clinical Trials Day – Praxis on putting people first

The association says the day (May 20) is a ‘joyful opportunity to pause in reflection, recognition, and admiration of all that has been accomplished thanks to clinical trials and the people behind them’. OSP had plenty of questions to put to Karen Grobe, senior vice president, managing director and Karen Renzi, vice president, strategy both at […]

Medicine

How is SamaCare reducing financial and patient burdens?

This round was led by new investor Questa Capital, with participation from existing investors Vive Collective and South Park Commons. With this new investment, SamaCare aims to accelerate the development of its one-stop patient access platform, designed to save healthcare organizations time and resources while ensuring that patients receive therapy sooner. The company says it […]

Medicine

How can One2Treat revolutionize clinical trial designs?

One2Treat aims to make the clinical trial process as seamless as possible and answered a number of the questions we put to Samuel Salvaggio who bridges clinical insights with biostatistics. Patient Engagement: How do you involve patients in the design and execution of your clinical trials? We place a strong emphasis on incorporating patient […]

Medicine

Startup facilitating catheter insertion by improving probe usability

Samuel Poulin, presented Install-VASc and shared his insights into another innovative project aimed at transforming ultrasound-guided catheter insertion, highlighting the potential for improved patient outcomes and reduced healthcare costs. He explained that in the evolving world of medical technology, the accurate insertion of catheters remains a significant challenge. “Currently, caregivers insert catheters by hand, which […]

Medicine

how can pharma companies fight antimicrobial resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As […]

Medicine

How can One2Treat revolutionize clinical trial designs?

Medicine

Pam Diamond – The Sound of Medicine

Here she explains all about the challenges and triumphs that saw her reach her position of chief medical officer at Curavit including her links to the Sound of Music’s von Trapp family. Could you give us an overview of your work? I received my medical degree from the University of Rochester School of Medicine in […]

Medicine

Durect’s hope for people with alcohol-related hepatitis

Durect Corporation is a late-stage biopharma company championing the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury and cancer through the use of larsucosterol. James E. Brown, president and CEO of Durect, said: “We’re pleased with the FDA’s decision to grant Breakthrough Therapy designation to […]

Medicine

PrecisionLife and Metrodora Institute join forces

The goal is to propel clinical trials aimed at speeding-up the diagnosis and treatment of ME/CFS and long COVID patients. The trials, slated to enroll up to 1,000 participants, are set to unveil outcomes as early as this year, marking a significant stride in the quest for enhanced medical solutions for these debilitating conditions. Myalgic encephalomyelitis, […]

Medicine

How has geopolitical tension created problems for life sciences?

Medicine

Indica Labs gets FDA clearance for platform giving pathologists the best tools

This significant 510(k) clearance permits the use of HALO AP Dx in conjunction with the Hamamatsu NanoZoomerS360MD Slide scanner for in-vitro diagnostic use and paves the way for its future compatibility with additional FDA-cleared slide scanners. HALO AP is a globally deployed enterprise digital pathology platform that Indica Labs says has revolutionized the analysis, management, […]

Medicine

Novartis to showcase next-gen manufacturing solutions at BIO 2024

BPR: What new products or innovations is Novartis showcasing at BIO 2024 this year? At BIO 2024, Novartis Contract Manufacturing will actively demonstrate its commitment to supporting both existing and potential manufacturing partners around the globe, by showcasing its cutting-edge technologies. These capacities include mammalian drug substance manufacturing, microbial drug substance manufacturing, cell therapy, gene […]

Medicine

ReciBioPharm seizes viral and nucleic acid therapeutics opportunity at BIO 2024

BPR: What new products or innovations is your company showcasing at BIO 24? This year, we’re showcasing our fully integrated, digitally controlled, nested RNA manufacturing platform. BPR: What are you hoping to achieve from the event? We aim to share our innovations with mRNA developers and look forward to connecting with new friends and family […]

Medicine

‘BIO is a very important convention for us’

BPR: What new products or innovations is Cytiva showcasing at BIO 2024 this year? BIO is a very important convention for Cytiva. We are really looking forward to speaking with our customers and potential customers about how we can better collaborate and work together to accelerate the development of advanced therapeutics. Just ahead of BIO, […]

Medicine

Ecolab Life Sciences to showcase bioquell qube and more at BIO 2024

BPR: What new products or innovations is your company showcasing at BIO 2024 this year? This year we are delighted to share our innovative modular rapid bio-decontamination isolator – the bioquell qube. Providing all the essentials in isolation technology to protect critical bio-processing aseptic steps in a plug and play modular isolator which can be scaled up […]

Medicine

Inceptua expands early access program for cefiderocol in Latin America

While antimicrobial resistance is on the rise, a greater number of people still succumb to infections caused by drug-sensitive bacteria. The study reveals that ongoing development of drug resistance is unavoidable, driven by the large populations of pathogens and their exposure to antibiotics. Furthermore, the researchers say, opportunistic pathogens will continue to endanger patients with […]

Medicine

Elinzanetant shows significant reduction in menopausal hot flushes

Detailed results from studies Oasis 1 and 2 will be showcased at the 2024 ACOG Annual Clinical & Scientific Meeting in San Francisco. The studies demonstrate that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flushes, associated with menopause in women. This […]

Medicine

New drug offers safer, non-toxic alternative for pain relief

The drug, SRP-001’s promising results from its phase 1 trial were also published. The announcement was made by South Rampart Pharma Inc. and the study was led by Hernan Bazan, co-founder and CEO of South Rampart. It was titled “Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region,” […]

Medicine

Showcasing innovation in cell line development technology

BPR: What new products or innovations is Abzena showcasing at BIO 2024 this year? Abzena has recently launched our AbZelect and AbZelectPRO cell line development (CLD) platforms, to enable the rapid generation and selection of high-yielding mammalian cell lines for therapeutic protein and recombinant vaccine production. Thiobridge is Abzena’s conjugation technology that makes use of the […]

Medicine

Study highlights lack of awareness of cholesterol-related cardiac risks

Presented at ISPOR 2024, the findings emphasize the need for integrating patient needs and preferences into strategies for managing unhealthy cholesterol (low-density lipoprotein cholesterol or LDL-C). The community-led research, a first of its kind by Global Heart Hub, aims to drive action towards changing the course of atherosclerotic cardiovascular disease (ASCVD), the leading cause of […]

Medicine

Roquette’s new capsules – solving drug delivery issues

The company says its new product, built on its advanced Lycagel pea starch technology, offers manufacturers the freedom to select the optimal plasticizer combination, customizing formulations to meet diverse production and end-user needs. It also sets new standards in quality, stability, and performance for plant-based softgels. Gelatin-based softgel capsules are widely used in the nutraceutical […]

Medicine

Oral drug for kidney disease launched in China by Everest Medicine

This official launch marks a significant advancement in patient care in mainland China, introducing a new era in the treatment of IgA nephropathy (IgAN). IgA nephropathy (IgAN) is a common chronic kidney disease which mainly affects young adults. In IgAN a protein called immunoglobulin A (IgA) becomes trapped in the very fine filters of the kidney (glomeruli), causing […]

Medicine

Sanofi’s billion euro investment in France

This move is part of a larger €3.5 billion program within the country. The investment will be allocated to facilities in Vitry-sur-Seine in Val de Marne, Le Trait in Seine-Maritime, and Lyon Gerland in the Rhône region. Its primary objective is to reduce France and the wider EU’s dependence on manufacturing capacity outside the region, […]

Medicine

AI platform to be used in fight against cancer

Brian Hashemi, executive chairman and CEO of Novigenix, and Sabine Tejpar, founder of the IMMUcan Consortium, are leading this collaborative effort aimed at driving groundbreaking advancements in immuno-oncology through the amalgamation of cutting-edge technologies and collaborative expertise. The IMMUcan Consortium, under the guidance of Merck and the European Organisation for Research and Treatment of Cancer […]

Medicine

Has the battle against antipsychotic weight gain been won?

The Virginia-based company has revealed promising results from its phase 1b clinical trial assessing RDX-002, a novel small molecule therapy designed to address this pressing medical concern. The trial, conducted over two weeks, has yielded findings that emphasize the potential of RDX-002 in mitigating the adverse metabolic effects associated with antipsychotic medications, the company says. […]

Medicine

Owlstone Medical secures $6.5M for breath-based diagnostics

The money is to support the development of breath-based diagnostics for infectious diseases. The funding comprises a $5 million equity investment and an initial $1.5 million grant from the Bill & Melinda Gates Foundation, marking the foundation’s first equity position in a breath diagnostics company. The Bill & Melinda Gates Foundation (BMGF), formed from the […]

Medicine

Montreal miniseries – startup AFX Medical’s brainchild

Yesterday, (April 29), during a packed program of events, OSP was invited to watch presentations from four startups nurtured by Centech, that are reaching a critical stage in their projects. In a series of articles, these will be covered as part of several interviews, presentations, and visits, OSP was lucky enough to attend and cover. […]

Medicine

Lonza unveils AI-powered route scouting service for small molecule development

This offering aims to streamline the identification of synthetic routes for novel active pharmaceutical ingredients (APIs) by using Lonza’s extensive chemical supply chain intelligence and in-house expertise, combined with AI technology from Elsevier (Reaxys). The development pipeline for small molecule APIs is becoming increasingly complex, driven by the intricate structures of modern drug candidates. As […]

Medicine

Life sciences sector deserves a purposeful fit-to-fund programme

Titled ‘State of the Discovery Nation (SODN) 2024: Fostering a Dynamic, Sustainable Medicines Discovery Sector,’ the report published in conjunction with the UK BioIndustry Association and the Association of the British Pharmaceutical Industry highlights the critical need for concerted efforts to mitigate funding risks in medicines discovery and attract more investors. The report emphasizes the […]

Medicine

Shionogi pays Maze $150M to advance Pompe disease compound to trial

The agreement, announced today, underscores Shionogi’s dedication to expanding its pipeline in the rare disease domain. According to the National Organization for Rare Disorders (NORD) Pompe disease is a rare disease continuum with variable rates of disease progression and different ages of onset. First symptoms can occur at any age from birth to late adulthood. […]

Medicine

Development leap in addressing neurological conditions

This first-in-human study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117567 in healthy adult participants. The compound, a muscarinic M1 preferring (M1/M4) selective agonist, holds promise for addressing cognitive symptoms in patients with neurological and neuropsychiatric conditions. Muscarinic receptors, pivotal in various bodily functions including brain activity, have long been targeted for […]

Medicine

Is investing in mental health a smart business decision?

As Mental Health Awareness Week 2024 approaches, employers must recognize the power of data in improving staff wellbeing. Peter Taylor, senior director, and global head of human resources at Phastar, sheds light on this critical issue, emphasizing the need for proactive measures to support employees’ mental health. “The costs of low mental health, both personal […]

Medicine

Montreal’s Displaid – disrupting the cardiac landscape

This week the second in the series comes from Jonathan Boudreau, a co-founder of Displaid and a finalist in the Effervescence conference startup competition. He spoke out on Displaid’s mission: to disrupt the landscape of cardiac care without resorting to invasive procedures. His presentation was a call to address the looming global crisis of heart […]

Medicine

Boehringer’s global health mission: Fighting C-R-M diseases

This initiative will integrate select Walgreens community pharmacies as clinical trial sites, focusing on phase 3 trials for individuals grappling with obesity or being overweight, and type 2 diabetes. The collaboration seeks to break down barriers and foster representation, particularly among underrepresented communities among black and Hispanic adults in the US. Ramita Tandon, chief clinical […]

Medicine

From ninth grade biology to the STEM industry

Having been originally interested in engineering, she soon realized that path was not the best for the set of skills she had before beginning her journey into life sciences. OSP: Could you give us an overview of your work? My current role is Vice President of Scientific Affairs at BioIVT. I lead an amazing team […]

Medicine

PCI Pharma Services $100M capital investment fill finish project

The ongoing construction and validation activities mark a significant step in the company’s ambitious $100 million capital investment project, tipped for completion later this year, with full-scale production set to commence in early 2025. The new 50,000-square-foot facility will feature twin lyophilizers and a state-of-the-art large-scale isolator filling line, forming the backbone of PCI’s commitment […]

Medicine

Elevating healthcare product launches through smart data

Inizio Engage, a life science consulting firm, is aiming to address this challenge through its data-driven and evidence-based methodology. During a presentation at Reuters Pharma USA, Mike Stout, president, US commercial, and Sese Abhulimen, president, global decision optimization, outlined how the company is focused on optimizing brands and accelerating impact using data. “We want to […]

Medicine

An interview with LGM Pharma

LGM Pharma, under Raje’s visionary stewardship, has undergone a remarkable journey of expansion and transformation since its acquisition by New Harbour Capital Private Equity in 2018. Initially focusing on supply chain logistics, the company has since diversified its offerings to encompass manufacturing, formulation development, and analytical services, solidifying its position as a holistic solution provider […]

Medicine

An improvement for lab rat welfare as Olden Labs says AI can help

Using artificial intelligence (AI), genetic engineering, and robotics, the company said it proudly introduces the world’s first automated animal research lab. Founded by a team of experts spanning diverse disciplines, including a Harvard PhD biologist, a Forbes 30 Under 30 AI developer, and engineers from 10X Genomics and Apple, Olden Labs stands backed by supporters […]

Medicine

Psychedelic hub offers course for professionals to develop in the field

Starting on May 27 in London, this practitioner program is designed for healthcare professionals and students in professional training who are interested in delving into the psychedelic-assisted therapy area. The course aims to equip participants with the necessary knowledge to safely, ethically, and effectively administer psychedelic treatments within a regulated healthcare environment. Upon completion of […]

Medicine

A look into Organon’s mission and vision

However, Canadian company Organon wants to change this, a spin off from Merck & Co., Inc., it has a mission to focus solely on women’s health globally. The company is led by by president and managing director Michael Casia and he says: “Our mission is deeply rooted in the belief that women’s health deserves dedicated attention and resources. “We […]

Medicine

A look into Organon’s mission and vision

However, Canadian company Organon wants to change this, a spin off from Merck & Co., Inc., it has a mission to focus solely on women’s health globally. The company is led by by CEO Michael Casia and he says: “Our mission is deeply rooted in the belief that women’s health deserves dedicated attention and resources. “We aim to […]

Medicine

Owlstone Medical secures $6.5M for breath-based diagnostics

Medicine

From banking to biotech – Renée Aguiar-Lucander’s unique path in science

BPR: Could you give us an overview of your work? I joined Calliditas Therapeutics as CEO in 2017, and in this role I have led the company from a small team of just 10 people to an international biopharmaceutical company with over 200 employees. Calliditas is now a successful commercial-stage biopharma company with a pipeline […]

Medicine

Montreal miniseries – startup AFX Medical’s brainchild

Medicine

Lonza unveils AI-powered route scouting service for small molecule development

Medicine

Has the battle against antipsychotic weight gain been won?

Medicine

Wendy Cheng on global AI regulation in pharmaceuticals

Wendy specializes in applying advanced methodologies to address complex healthcare research challenges and has used machine learning and other predictive modelling techniques, including latent class analysis to identify cost clusters in disease patient populations, and group-based trajectory analysis to identify disease prognosis patterns. Can you provide insights into the current global regulatory landscape governing AI […]

Medicine

Adapting to regulatory shifts and market demand

BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business? Our new APS-qualified manufacturing facility aligns with Annex 1 compliance standards, which are critical for clients targeting European markets, while also meeting the highest quality standards for U.S. markets. Unlike older facilities undergoing retrofitting to meet these standards, […]

Medicine

Platform integrates formulation development and on-demand GMP manufacturing

OSP caught up with them before the event, which is taking place in the Pennsylvania Convention Center, Philadelphia, between May 7-9. How does your company stay ahead of industry trends and developments in the pharmaceutical sector? Quotient Sciences is built on our three foundational pillars of science, agility, and culture. We’ve always maintained that a […]

Medicine

Potential for Astellas’ new prostate cancer drug with EC approval

“The extended approval allows enzalutamide to be administered either as monotherapy or in combination with androgen deprivation therapy (ADT) for adult men with high-risk biochemical recurrent (BCR) nmHSPC who are unsuitable for salvage-radiotherapy,” said president and CEO of Astellas, Naoki Okamura. “This approval is based on results from the phase 3 Embark trial in 1,068 […]

Medicine

Women in Science Wednesday – Karen Ooms’ journey to Quanticate

She works as joint chief operating officer at a specialist biometrics CRO called Quanticate where she looks after the programming and statistics functions. Could you give us an overview of your work? My role is rather broad but roughly falls into the following categories, although every day is unique! Ensuring that the needs of our customers […]

Medicine

on industry trends and bringing new treatments to market

We caught up with the company once more and put a few more questions to CEO Sebastian Coppe about the forthcoming CPhI North America being held from May 7-9 at the Pennsylvania Convention Center. As a company which has launched to address strategic challenges in the biopharma industry today, where do you see the value […]

Medicine

An interview with LGM Pharma

Medicine

Elevating healthcare product launches through smart data

Inizio Engage, a life science consulting firm, is aiming to address this challenge through its data-driven and evidence-based methodology. Duering a presentation at Reuters Pharma USA, Mike Stout, president, US commercial, and Sese Abhulimen, president, global decision optimization, outlined how the company is focused on optimizing brands and accelerating impact using data. “We want to […]

Medicine

WuXi AppTec strongly denies sharing clients’ data with Beijing

It has been widely reported that in early February US intelligence officials told senators working on a biotech security bill, off the record, that WuXi AppTec had transferred the US intellectual property without consent according to two sources. Reuters reported that a classified briefing to several senators was led by the FBI, the State Department, […]

Medicine

Oncimmune ventures into age-related disease biomarker research

The company says its renowned ImmunoINSIGHTS platform is recognized for its prowess in antibody marker discovery and will now be used to unearth novel biomarkers associated with ageing and age-related conditions. It says this will underscore Oncimmune’s unwavering commitment to confronting the multifaceted challenges posed by aging, where it aims to play a key role […]

Medicine

Vivalink and RSRT to accelerate treatments for Rett syndrome

The collaboration marks a significant stride towards shifting symptom assessment paradigms in Rett syndrome through the use of cutting-edge wearable technology. Rett syndrome manifests with a range of challenges including speech impairments, motor skill deficiencies, and autonomic dysfunction, impacting vital functions such as breathing patterns, heart rate variability, and sleep. To address the critical need […]

Medicine

Momentous CE marking for life-saving device

This achievement marks a significant milestone in the company’s journey, granting European Union medical providers access to a life-saving device and highlighting the company’s global expansion efforts. The CE marking was granted under stringent European Medical Device Regulations, signifies the approval of the COBRA-OS as a safe and effective medical device for aortic occlusion. Notably, […]

Medicine

Ultrahuman launches US smart ring manufacturing facility

It is now poised to become the first facility in the United States dedicated to producing wearable rings. This strategic move comes hot on the heels of a recent $35 million investment, propelling Ultrahuman towards the top of the smart ring market. Located in Indiana, the UltraFactory is set to start operations within the next six […]

Medicine

‘We are all about making sterile supply simple’

BPR: What new products or innovations is your company showcasing at CPHI North America this year? We are a CMO focused on supporting the needs of clients looking to bring terminally sterilised injectables to market. For the US in particular in 2022 48% of all drug shortages related to injectable medicines. The ability to ensure a […]

Medicine

How Biosynth is coming to CPHI North America with an ‘even bigger toolbox’

BPR: What new products or innovations is your company showcasing at CPhI North America this year? With the new acquisitions over the past 2 years, Biosynth comes to CPHI North America this year with an even bigger tool box. Along with our novel chemiluminescent and fluorescent small molecule enzyme substrates, two of our newest and […]

Medicine

Growing mini trees – exploring QS-21, the vaccine adjuvant

We delved into the fascinating world of vaccine adjuvants, particularly focusing on QS-21, a purified plant extract derived from the soap bark tree (Quillaja saponaria) indigenous to Chile, Peru, and Bolivia. Known for its potential in boosting vaccine effectiveness, QS-21 contains water-soluble triterpene glycosides, a type of compound called saponins, which are believed to enhance […]

Medicine

Women in Science – Katrina Rice on making the world a little better

As chief delivery officer, biometrics services at eClinical Solutions, Katrina is driving clinical data transformation, and building a thriving services organization equipped to address growing trial complexity and accelerate cycle times through end-to-end data strategies and practical innovation. Could you give us an overview of your work? As eClinical Solutions’ Chief Delivery Officer, Biometrics Services, […]

Medicine

Test that can enhance the likelihood of identifying colorectal cancer produced by Mainz Biomed

Mainz Biomed has been manufacturing ColoAlert which is a non-invasive mt-stool DNA screening test designed for early detection of cancer. OSP wanted to know more about this potentially life-changing and life-saving test and sat down with Mainz to find out more. OSP: What is ColoAlert and how does it function in the detection of colorectal […]

Medicine

Against animal testing in pharma? See what the industry says

The company said its project represents a significant investment of $200 million over the past four years, with an additional $300 million earmarked for the next five years. In what it has called a comprehensive investment strategy, Charles River said it encompasses a range of technological innovations, strategic partnerships, and advocacy efforts all geared toward […]

Medicine

Giving the gift of health by finding solutions to the cost and complexity of prescription drugs

The company was founded by healthcare technology startup veteran John Romano, and the company launched a pilot program in Ohio and quickly expanded into all 50 states. Today, the team has grown to include technologists, data scientists, patient advocates, and path-to-purchase experts and the company’s purpose is simple: to help people get the prescribed care […]

Medicine

LGM Pharma to meet growing demand in geriatric and pediatric areas

As the company will be attending CPhI North America, OSP caught up with Hamilton Lenox, senior vice president of business development and operations. How does your company stay ahead of industry trends and developments in the pharmaceutical sector? LGM remains at the forefront of industry trends and developments in the pharmaceutical sector by prioritizing customer […]

Medicine

world’s fifth leading killer by 2040 if left untreated

Following on from this news, OSP put several questions to the pharma giant to dig deeper into the study. Can you provide more insights into the methodology used in the IMPACT CKD study, particularly regarding how the modeling analysis was conducted and the data sources utilized? The IMPACT CKD microsimulation model simulates chronic kidney disease […]

Medicine

The doors have opened at Thermo Fisher Scientific’s new innovation hub

The state-of-the-art facility will be an innovation and co-creation/working lab that supports the creation, testing, and validation of new services and products that help advance clinical trial research. OSP interviewed Sarah Englert, the senior director of innovation and program management (pictured) about what the lab means to the company and what it hopes to achieve. OSP: […]

Medicine

Pharma embraces combined PV solutions IQVIA study reveals

In her current role as senior director of integrated pharmacovigilance (PV) solutions, she provides senior leadership and oversight to the safety tech-service integrated offering delivery combining IQVIA’s expertise both from a technology and service perspective focusing on accuracy, efficiency, compliance, standardization, and automation. Here she discusses a recent study and how PV is managed by […]

Medicine

A new weapon against gonorrhoea

These findings, set to be showcased at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global event in Barcelona on April 30, 2024, mark a significant advancement in combatting the escalating challenge of gonorrhoea, particularly concerning drug-resistant strains. In the trial, gepotidacin demonstrated a robust microbiological success rate of 92.6%, showcasing its non-inferiority […]

Medicine

Charles River – looking for alternatives to animal testing

The project represents a significant investment of $200 million over the past four years, with an additional $300 million earmarked for the next five years. This comprehensive investment strategy encompasses a range of technological innovations, strategic partnerships, and advocacy efforts all geared toward reducing reliance on animal testing. “Advances in science and technology have brought […]

Medicine

Qinecsa acquires Insife to elevate pharmacovigilance tech

This strategic move, the company says, aligns with Qinecsa’s vision to emerge as the premier provider of digital pharmacovigilance solutions. With a strong focus on innovation and excellence, Qinecsa says it has earned a reputation as a trusted global partner in pharmacovigilance. With platforms like Reportum and CVW, Qinecsa believes it empowers life science companies […]

Medicine

AstraZeneca’s Impact CKD study: Alarming projections for 2032

The study forecasts that by 2032, up to 16.5% of the population in these countries could suffer from CKD, with a staggering rise of up to 59.3% in advanced-stage cases. Ruud Dobber, executive vice-president of AstraZeneca’s BioPharmaceuticals business unit, stressed the gravity of these projections, stating, “Our modelling emphasises the enormous impact CKD could have […]

Medicine

The key to getting pharma trials up and running

OSP spoke to Frontsin about why the CROs are under greater pressure to deliver measurable results quickly at lower costs. He said the company’s growth initiative enables CROs to evaluate the power of Oracle technology with their potential sponsors. As part of the CRO Growth Initiative, many CRO professionals have also taken advantage of the program’s […]

Medicine

Rare primary immunodeficiency drug trial’s enrollment complete

Leniolisib, marketed as Joenja in the US, obtained FDA approval in March 2023 for treating APDS in adult and pediatric patients aged 12 and above. Pharming aims to incorporate data from this trial into global regulatory submissions for leniolisib’s pediatric approval for APDS, starting in 2025. Anurag Relan, chief medical officer of Pharming, said: “This […]

Medicine

Medicxi invests $40m in D3 Bio, enhancing oncology pipeline

The investment will accelerate the development of D3 Bio’s pipeline of oncology compounds, particularly its lead asset DS3-001. D3S-001 is a new generation small molecule KRAS G12C inhibitor with differentiated properties and could potentially address the large unmet need of patients with cancers harboring KRAS G12C mutations. The treatment is currently in phase 2 development […]

Medicine

Andreas Raabe – carving out a niche for Adragos Pharma

Andreas Raabe, the visionary CEO behind Adragos Pharma, shares his insights into the company’s recent expansion and strategic objectives. With a background in biology, Raabe embarked on a mission to transform the CDMO landscape, aiming to carve out a niche for Adragos Pharma as a dynamic and agile player in the pharmaceutical industry. Reflecting on […]

Medicine

Selkirk’s rises to manufacturing biologics challenges with expansion

Founded in 2018 by a group of industry veterans with diverse expertise, the company has swiftly carved a niche for itself in the fill/finish segment of pharmaceutical manufacturing. With a relentless focus on reliability and a commitment to excellence, the company says it is poised for a significant expansion that will not only bolster its […]

Medicine

Is the headache over for migraine sufferers?

The National Institute for Health and Care Excellence (NICE) has endorsed atogepant, a novel oral medication, as a preventive treatment for both chronic and episodic migraines. This recommendation is poised to change migraine management for up to 170,000 individuals across England. Atogepant, also known as Aquipta and produced by AbbVie, represents a major shift in […]

Medicine

Hope for Fragile X Syndrome: Zatolmilast granted Orphan Status

This was announced yesterday (April 12) by the executive officer, Isao Teshirogi, of Shionogi BV, the European subsidiary of Shionogi & Co., Ltd. Pete Richardson, managing director, UK Fragile X Society, said: “FXS is a frequently misunderstood condition and too often individuals and families struggle to gain access to the support they need from health […]

Medicine

Experts hail Cystic Fibrosis drug for babies and children a breakthrough

This discovery marks a significant moment for Cystic Fibrosis treatment, with experts hailing it as a breakthrough. Lead researchers have emphasized the monumental nature of this finding, especially as it pertains to the treatment of Cystic Fibrosis in infants. The drug, Ivacaftor (Kalydeko), originally formulated for adults, has gradually gained approval for use in younger […]

Medicine

Recent pharma industry appointments that should be on your radar

By Isabel Cameron and Liza Laws 11-Apr-2024 – Last updated on 11-Apr-2024 at 12:27 GMT Facebook Twitter Linkedin Email to a friend Related tags Pharma industry appointments People on the move Pharmaceutical industry Bio Pharma Reporter and Outsourcing Pharma is back with our latest instalment of movers and shakers – breaking down all the key […]

Medicine

FDA’s thumbs up for Prenosis’ AI for sepsis: a game-changer?

Prenosis, a player in the realm of health technology, has secured this milestone with the full authorization of its diagnostic software, which it says marks a watershed moment in the field of healthcare innovation. Sepsis, a grave medical condition triggered by the body’s heightened response to infection, has long posed quite a challenge to healthcare […]

Medicine

Elisa Cascade on why women should never be afraid to ask

OSP: Could you give us an overview of your work? With more than 30 years of experience in the clinical research industry with a focus on using technology to transform clinical research for all stakeholders, I sit on the Advarra Executive Leadership Team and serve as Advarra’s Chief Product Officer. In this role, I am […]

Medicine

Andaman7 unveils AI-powered health record update

This update introduces three new AI tools geared towards providing patients with deeper insights into their health records, thereby enhancing communication and understanding between patients and healthcare providers or researchers. The new AI tools integrated into Andaman7 v5 include Simplification, Summarization, and Translation. Simplification utilizes AI to convert complex medical terminology into easily understandable text […]

Medicine

Can NHS England and Gilead Sciences eradicate hep C by 2025?

This partnership aims to eliminate hepatitis C by 2025, aligning with global efforts to eradicate the virus and improve public health outcomes. Since its inception in 2019, the Strategic Procurement agreement between Gilead, NHS England, and various stakeholders has made significant strides in treating and curing hepatitis C. Over 84,000 individuals have benefited from this […]

Medicine

Step forward in Scotland for endometrial cancer treatment

Clinicians in Scotland can now administer dostarlimab in conjunction with platinum-containing chemotherapy for adult patients diagnosed with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer, who are suitable candidates for systemic therapy. With approximately 740 new endometrial cancer cases reported annually in Scotland, an estimated 240 of these cases progress to […]

Medicine

Medicxi invests $40m in D3 Bio, enhancing oncology pipeline

Medicine

FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension patients

It is the first and only once-daily single-tablet combination therapy by the US Food and Drug Administration (FDA). OPSYNVI combines macitentan, an endothelin receptor antagonist (ERA), with tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a streamlined treatment option for adults with PAH. PAH, characterized by the narrowing of small pulmonary arteries and elevated blood pressure […]

Medicine

Beacon Biosignals expands sleep analysis capabilities

This milestone marks a significant expansion of Beacon’s analysis platform, extending its application from at-home sleep monitoring to comprehensive coverage of traditional in-lab polysomnography (PSG). The software, developed by Beacon Biosignals, automatically stages sleep from electroencephalogram (EEG) signals of clinical PSG recordings. This advancement promises to aid in the diagnosis and evaluation of sleep and […]

Medicine

How can the industry overcome real-world data integration challenges?

Q: How has the use of data evolved in clinical trials and what are the challenges that the industry is facing in this area? Data is the lifeblood of the pharmaceutical industry. Data integration from a myriad of sources supports many important areas of research – from trial site identification, patient finding and eligibility and […]

Medicine

Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’

We sat down with Dr Laura to find out the origins of her fascination with science, the importance of effective communication and how she fosters a diverse working environment. OSP: Could you give us an overview of your work? As vice president of research at CluePoints, I support a team of research scientists responsible for […]

Medicine

More from Pluss as it launches Celsure XL VIP pallets

The company is aiming to transform pharmaceutical shipping and storage standards worldwide. Engineered to meet the evolving needs of the global pharmaceutical market, Pluss promises these VIP pallets provide unmatched reliability, affordability, and sustainability. The company says the pallets are meticulously crafted using ‘premium materials and feature cutting-edge vacuum-insulated panel (VIP) technology’ combined with phase […]

Medicine

Trialbee -on a mission of improving patient recruitment

During the successful SCOPE Summit held in Orlando earlier this year, OSP was delighted to catch up with Matt Walz, who is CEO of the company that gets patients from referrals through to clinical trials using its Honey platform. OSP: Can you provide an update on Trialbee since we met at the last conference? MW: […]

Medicine

Using AI – SimBioSys and General Inception’s cancer pact

The collaboration, announced today (April 3), is poised to leverage advanced AI and biophysical modeling to gain deeper insights into tumor biology and accelerate the creation of safer and more effective cancer therapies. “We’re excited about this collaboration because all new oncology drug incubations under General Inception will be able to use SimBioSys’ state-of-the-art PhenoScope […]

Medicine

Vox Pop Pharma – the industry speaks

The news that broke yesterday (April 3) confirmed the collaboration’s aim to speed up the creation of safer and more effective cancer therapies and saw responses come in from across the pharma sector. Let’s hear what they had to add to the story. Dr Jo Varshney, CEO, and founder of VeriSIM Life, says: “Based on […]

Medicine

More from Pluss as it launches Celsure XL VIP pallets

Medicine

Molecure’s 2023 milestones and what lies ahead

The company wantd to share some of its highlights and significant advancements in both clinical and preclinical programs. The company aims to continue its momentum into 2024 and 2025 with robust research initiatives. In a statement, Marcin Szumowski, CEO of Molecure S.A., emphasized the exceptional progress made during 2023. “Last year was an exceptional year […]

Medicine

HUTCHMED & Innovent Secure NDA for cancer combo in China

The drug is intended for the treatment of advanced endometrial cancer and the news carries significant weight as it comes with Priority Review status, underscoring the potential impact of this therapeutic approach in addressing a critical medical need. “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab. […]

Medicine

Bora Pharmaceuticals acquires Upsher-Smith from Sawai and Sumitomo

With this acquisition, Upsher-Smith now operates as a wholly-owned subsidiary under the Bora Group umbrella. Bobby Sheng, chairman and CEO of Bora Group, assumes the position of chairman for Upsher-Smith, while Rich Fisher, COO and president of Upsher-Smith, remains in charge of day-to-day operations, reporting directly to Mr. Sheng. Mr. Sheng emphasized the strategic significance […]

Medicine

Quibim AI: Revolutionizing liver disease diagnosis

The device is aimed at transforming the diagnosis and management of diffuse liver diseases through advanced AI-driven MRI analysis. The company announced the product launch, which has received CE and UKCA marks for use in the European Union and the United Kingdom, marking a significant milestone in liver disease diagnostics. Chronic liver diseases pose a […]

Medicine

Enhancing AI in the clinical trial landscape

OSP: Could you start by sharing a bit about your background and how you got involved with Cluepoints? PH: Certainly. We established the company in 2012, and over the years, especially in recent times, we’ve seen significant growth in the adoption of risk-based quality management (RBQM) and associated statistical AI and machine learning software within […]

Medicine

Denmark and NVIDIA aiding innovation across multiple sectors

At the heart of this initiative lies the deployment of one of the world’s most powerful AI supercomputers, signaling a significant leap forward in research and innovation across diverse fields, including healthcare, life sciences, and environmental sustainability. The partnership, lead by the Novo Nordisk Foundation and the Export and Investment Fund of Denmark (EIFO), signifies […]

Medicine

Safeguarding emotional well-being through rare disease journeys

The Foundation is a patient-led nonprofit organization dedicated to enhancing access to diagnosis, research, and care for individuals grappling with undiagnosed and ultra-rare diseases. Mary Morlino, a patient navigator deeply involved in supporting undiagnosed and ultra-rare patients through UDNF’s patient navigation program, led this initiative alongside Cristol Barrett O’Loughlin, the founder and CEO of Angel […]

Medicine

Partnership announced to advance personalised medicine

This is intending to advance the development of personalised medicines, improve drug efficacy and outcomes in patients with specific chronic disorders by combining dose-optimised drug therapy with digital care. Dr Paul Goldsmith is chief medical officer and innovation officer, co-founder and president of Closed Loop Medicine. He said: “As clinicians, we know that dosing of […]

Medicine

This week’s woman in science

From math hater to a leader in clinical data, it’s been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar. She tells us how she discovered her love of statistics, why honing her craft has fed her passion to make a difference, and that she will never pull the […]

Medicine

The trial has started – can psychedelics help with alcohol addiction?

The trial, already underway at King’s College London, will now expand to include Clerkenwell Health’s research facility near Harley Street, London. It is focusing on evaluating the safety, tolerability, and pharmacodynamic effects of a novel psychedelic compound, BPL-003, in combination with psychological support tailored for AUD patients. BPL-003, a synthetic formulation of mebufotenin (5-MeO-DMT), promises […]

Medicine

integrating technology to enhance the patient experience

It was an insightful and interesting discussion about feeling close to patients as well as the importance of having a strong female role model and leader. OSP: Could you both introduce yourselves and tell us about your roles at CTM and what drew you to the company? KS: I’m Katherine Seay, the executive vice president […]

Medicine

skip the cliches and focus on the customers

In April 2022, Anju, a leading provider of comprehensive software solutions to the life sciences industry, announced the appointment of Laurence (Larry) Birch as its chief executive officer.Larry brought more than three decades of life sciences, software, and global management experience to Anju, and the company said he was uniquely prepared to lead the company […]

Medicine

Beacon Biosignals expands sleep analysis capabilities

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using real-world data to bridge the evidence gap

LL: Before we delve into the specifics of your work at Atropos Health, could you provide a bit more background about yourself and your involvement in tech-enabled trials? BH: Certainly. I’m the CEO and co-founder of Atropos Health. My journey into the realm of health tech and data sciences began during my tenure at Stanford […]

Medicine

how is ICON overcoming real-world challenges?

In an interview he spoke to OSP about data integration and overcoming challenges to optimise clinical trial diversity. OSP: How has the use of data evolved in clinical trials and what are the challenges that the industry is facing in this area? Data is the lifeblood of the pharmaceutical industry. Data integration from a myriad […]

Medicine

Meyos €2.3 million for improving lives of CKD patients

Led by Cenitz and joined by investors including KIMA Ventures, Advans Lab, and Bpifrance, the funding will support Metyos in developing its biowearable sensor and disease management platform. Founded by CEO Alexandre Boulanger and CTO Olga Chashchina, Metyos aims to transform CKD management by providing continuous health monitoring through its technology. Alexandre Boulanger, CEO and […]

Medicine

can it transfrom clinical research?

By integrating various patient-centric outcomes into a single treatment assessment, One2Treat aims to accelerate the delivery of new treatments to the market while reducing trial sample sizes. Traditional clinical studies often focus on a limited number of primary endpoints, neglecting valuable data and failing to capture the full impact of treatments on patients’ lives. One2Treat’s […]

Medicine

FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension patients

Medicine

eClinical empowering organizations to be more efficient and effective

During SCOPE 2024 in Orlando, Dawn Kaminski, vice president of business development operations at eClinical Solutions, shared valuable insights into the company’s latest innovations and their impact on the industry. Kaminski, with over 25 years of experience in the field, outlined eClinical’s commitment to revolutionizing clinical trial operations through their platform, the eClinical Data Cloud. […]

Medicine

DP World building resilience into healthcare supply chains

This is the company’s approach despite being amidst increasing disruptions to global trade. With 1,000 jobs already created and plans for further expansion, DP World seeks to address the complex logistics challenges faced by the healthcare and pharmaceutical industries. The expansion comes at a crucial time when businesses are prioritizing strategies to enhance resilience in […]

Medicine

myTomorrows collaborates with the ALS Association

myTomorrows is a global health technology company and says it is revolutionizing the landscape of clinical trial accessibility through its original platform. The partnership with the ALS Association underscores myTomorrows’ commitment to ensuring that individuals facing life-threatening diseases have access to all potential treatment options. Under this collaboration, myTomorrows says the ALS Association will make […]

Medicine

What are pharma titans hoping to achieve at this year’s DCAT?

Outsourcing Pharma addressed a number of those attending to produce a ‘written roundtable of what these companies wanted to achieve during this big week in the pharma calendar. Representing a diverse spectrum of expertise and vision, companies Enzene, Adragos, Quotient, Purolite, Tjoapack, Exothera, and Abzena have begun a collective journey with shared aspirations and distinct […]

Medicine

‘British companies investing in the UK should not be headline news’

The news comes after AstraZeneca CEO Pascal Soriot previously branded the UK as a ‘very unattractive’ place to do business. So, what changed and will the cash injection encourage other pharma giants to increase their investment in the UK? “AstraZeneca’s vaccine was integral to the pandemic response in 2020, demonstrating how homegrown innovation can have […]

Medicine

Quibim AI: Revolutionizing liver disease diagnosis

Medicine

Merck invests €300M in Korea bioprocessing center

This significant investment marks the largest by Merck’s Life Science business sector in the Asia-Pacific region to date and underscores the company’s dedication to expanding its presence in this rapidly growing area. Anticipated to create around 300 new jobs by 2028, this move solidifies Merck’s commitment to fostering growth and innovation in the region’s life […]

Medicine

Lonza to acquire manufacturing site from Roche in major $1.2 billion deal

The site, in Vacaville, California, is one of the largest biologics manufacturing facilities in the world, with a total bioreactor capacity of 330,000 liters. According to Lonza, the move will significantly increase its large-scale biologics manufacturing capacity for mammalian therapies and extend the presence of its facility network in the U.S. The company also plans […]

Medicine

Roquette snaps up IFF Pharma Solutions for $2.85 billion

According to Roquette, the tie-up will ‘rebalance’ its portfolio across health and nutrition, as well as expanding its pharma product portfolio range. It will also expand the company’s position in the ‘attractive’ excipients market and enhance Roquette’s US footprint. “After last year’s acquisition of Qualicaps, today’s announcement is a decisive step in our journey to […]

Medicine

Women in Science – Abzena’s Petra Dieterich on creating new medicines

She has held leadership positions in project management, technical operations, and business development. Working in the CRO and CDMO environment she has led projects for customers across the globe, helping them to achieve their goals in clinical trials and low-volume commercial manufacture. Petra holds a D. Phil in synthetic organic chemistry and an MBA from […]

Medicine

Boost for patients with schizophrenia as BSM completes $14BN deal

This acquisition marks a significant milestone in the healthcare industry, particularly in the field of neuroscience, as it focuses on a potential first-in-class, small molecule muscarinic modulator known as KarXT treatment for schizophrenia in adults, which was invented at PureTech. Eric Elenko, chief innovation officer at PureTech, said: “This acquisition recognizes the enormous potential of KarXT […]

Medicine

FDA takes proactive approach to AI with clear strategy

With a dual focus on fostering innovation and ensuring patient safety, the FDA’s approach seeks to provide regulatory predictability, promote international collaboration, and issue guidance to support the development and evaluation of AI-enabled medical devices and drugs. One of the cornerstones of the FDA’s strategy is international cooperation. Recognizing the global nature of AI development […]

Medicine

Developing angina drug shows promise in trial with no patient headaches

The drug is aimed at treating chronic stable angina pectoris and conducted in Portugal, the exploratory phase 1a pharmacokinetics study, involving 16 healthy adult volunteers, concluded just before the end of last year (2023). The study focused on evaluating the pharmacokinetics of AUX-001, an oral, extended-release, once-daily version of nicorandil, a medication used to treat […]

Medicine

An alternative to Wim Hof’s icy dips? Discover nervous system modulator Nurosym

This approach, along with the increasingly popular practice of cold exposure, is reshaping the pharma and wearable industry’s understanding of how to optimize physiological and mental well-being. Extreme athlete Wim Hof has lauded the potential of these methods, emphasizing their profound impact on human health. Parasym, a pioneering neurotechnology company has introduced Nurosym, a wearable […]

Medicine

AION Labs’ CombinAble.AI: AI-powered antibody design redefined

This startup, born out of AION Labs’ startup challenge, aims to enhance the development of biological therapeutics by using the latest AI technologies. The company says CombinAble.AI represents a bold departure from traditional antibody optimization methods, which often involve laborious trial-and-error processes. By embracing advanced machine learning models and computational simulations, AION says the platform […]

Medicine

Women in Science – Maravai’s Kate Broderick’s fascinating story

Could you give us an overview of your work? I am the chief innovation officer at Maravai Life Sciences, the parent company to several life science brands, including TriLink BioTechnologies, Alphazyme, and Cygnus Technologies. I direct the research and development focus for the company and lead where we should be going in the future. Altogether, […]

Medicine

A Conversation with Dave Hanaman

I recently had the privilege of engaging in an enlightening conversation with Dave Hanaman, the co-founder of Curavit. Our conversation covered a wide array of topics, ranging from recent achievements to industry trends and the future trajectory of clinical research. Since our last discussion, Curavit has achieved a series of significant milestones, reflecting what they […]

Medicine

eClinical empowering organizations to be more efficient and effective

eClinical Innovations Streamline Clinical Trial Processes: Insights from Dawn Kaminski In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes. During SCOPE 2024 in Orlando, Dawn Kaminski, vice president of business development operations at eClinical, shared valuable insights into the company’s latest […]

Medicine

Urgent need for more epilepsy treatments says Angelini Pharma

Partnering with scale-up Wazoku, Angelini Pharma announced yesterday (March 11) that it aims to make use of the collective wisdom and expertise of its 700,000-strong crowd to drive innovation in epilepsy treatment. The challenge, titled ‘New Digital Approaches to Target Discovery in Epilepsy,’ marks the beginning of a strategic collaboration between Angelini Pharma and Wazoku. […]

Medicine

Cresset expands North American presence with new Boston site

The company has taken a significant step towards its international expansion by establishing a new facility in Boston, which is said to be one of the world’s premier hubs for pharmaceutical and life sciences industries. Operating from its headquarters in Cambridge, UK, Cresset has emerged as a global player in drug discovery solutions, with more […]

Medicine

Negev Capital celebrates psychedelic medicine milestones across globe

It says three of its companies have recently made groundbreaking achievements including Beckley Psytech, Filament Health, and MindBio Therapeutics. With this side of the industry developing rapidly and many claiming 2024 could be a watershed year for the sector, this pipeline of advanced clinical milestones and regulatory approvals in major markets including the US. “We […]

Medicine

Insights from Medable’s Colin Weller

The purpose of the discussion was to delve a bit deeper into the challenges and advancements in the pharmaceutical industry, particularly regarding the use of digital technologies in clinical trials. Colin’s background, industry frustrations, the impact on patients, and the future direction of clinical trials were just some of the subjects tackled. When asked about […]

Medicine

Chronic pain clinical trial produces highly encouraging results

The analysis, conducted by York Health Economic Consulting (YHEC), revealed compelling insights into the efficacy and cost-effectiveness of Celadon’s cannabis-based medicines in treating chronic pain. According to the report, patients enrolled in the feasibility study experienced a remarkable 49.6% reduction in pain scores within the first month of using cannabis-based medicines. This significant reduction was […]

Medicine

Survey uncovers several critical factors motivating physicians

They are across diverse therapeutic areas regarding their participation in clinical trials, challenges faced, and the status of digitalization within the field. The survey uncovered several critical factors motivating physicians to engage in trials, with 80% of them citing a significant emphasis on advancing scientific knowledge, 55% gaining early access to novel treatments, and 55% […]

Medicine

James Riddlle of Advarra shares insights on clinical trial engagement

James Riddle, the company’s senior vice president of global review services operations, shares valuable insights into the company’s vision and its impact on the healthcare industry. Throughout his conversation with senior editor of Ousroucing Pharma Liza Laws, a deeper understanding of the importance of engagement in clinical trials and the strategies employed to optimize participant involvement […]

Medicine

Medidata’s data-driven solutions to enhance patient experiences

They discuss their roles and experiences and how Medidata handles clinical research. The conversation covers topics ranging from patient engagement to technological advancements, highlighting the importance of human touch in clinical trials and the integration of data-driven solutions to enhance patient experiences. LL: Just to kick things off, could you both introduce yourselves and explain […]

Medicine

Parents inspire dementia-friendly finance app

This investment is poised to propel financial inclusion and equality for those navigating the challenges of dementia. It is geared towards assisting individuals living with dementia in managing their everyday finances, Hailing from Southampton, Jayne thought about the idea for Sibstar while caring for her parents, both grappling with dementia. Her appearance on the show […]

Medicine

ClinOne launches enhanced self-service platform

This expansion, powered by True Software as a Service (SaaS), introduces advanced self-service configuration management capabilities, empowering users to streamline clinical trial setup and management like never before, ClinOne says. This seminal development, the company says, signifies a significant shift in the clinical trial landscape, putting the power directly in the hands of customers to […]

Medicine

Slope at SCOPE – has the sample management revolution only just begun?

During SCOPE 2024 held in Orlando, he shared insights into the complexities of sample management and data reconciliation, alongside precision medicine, shedding light on the challenges faced by teams in the industry. The company, a provider of solutions for sample and data management in clinical trials, also unveiled its progressive tools aimed, it says, at […]

Medicine

Almac Group expands facilities to meet growing client demand

These expansions cater to the rising demand for commercial manufacturing, packaging, and peptide production, bolstering the operations of its business units, Almac Pharma Services and Almac Sciences. The first facility, spanning 32,000 square feet, is a custom-built high-volume plant for Almac Pharma Services, significantly amplifying the capacity for commercial manufacturing and packaging of sachet drug […]

Medicine

Form Bio and Gingko Bioworks join to accelerate drug development

This collaboration integrates Ginkgo’s licensable assets and manufacturing capabilities with Form Bio’s cutting-edge AI-driven solutions for gene therapy optimization. The partnership offers a comprehensive solution for gene therapy developers, streamlining product optimization and accelerating the journey from lab to clinic while conserving resources. By combining Form Bio’s in silico solutions with Ginkgo’s AAV products and […]

Medicine

How curiosity and determination inspired Hayley Crowe’s journey from bench to c-suite

BPR: Could you give us an overview of the work that you do at Purolite? What do you oversee at the company? I’m excited to share that we recently combined our life sciences business with our Purolite business – so I now have a global life sciences business, which is a new endeavour! However, […]

Medicine

Veterans’ charities rally to help find volunteers for PTSD trial

To find the 40, it will need to screen up to 1,000 people which is why several leading veterans’ charities have joined forces for this mission. Charities including Head Up and re:mind are joining MQ Mental Health Research in seeking ex-service personnel who might benefit from an innovative treatment, combining the use of an investigational […]

Medicine

Metabolon introduces ‘groundbreaking’ bioinformatics platform

The announcement was made at Biomarkers UK, and it was used as an opportunity to showcase Metabolon’s latest platform designed, the company says, to propel the landscape of metabolomics analysis. Drawing on more than two decades of industry-leading experience, Metabolon says it now boasts an established database of more than 5,400 biologically relevant metabolites, the […]

Medicine

Medidata’s data-driven solutions to enhance patient experiences

Medicine

Drug discovery key to Cresset and Enamine partnership

The partnership aims to champion innovative solutions for the early stages of the drug discovery process. The companies will focus on the development of revolutionary technology to facilitate the screening of ultra-large chemical spaces during the virtual screening process in drug discovery. Virtual screening involves searching libraries of small molecules to identify structures most likely […]

Medicine

ICON’s Kathleen Mandziuk drug development journey

She explains how the intense experience now gives her a new sense of pride and dedication to the transformation of healthcare and clinical research as she takes us on her journey to clinical research and drug development at ICON. Could you give us an overview of your work? I lead an incredible team of experts […]

Medicine

Proscia partners with Pramana to enhance digital pathology solutions

This partnership marks Pramana’s integration into the Proscia Ready partner alliance, aimed at empowering life sciences organizations and diagnostic laboratories with enriched, high-quality data, including DICOM images, for enhanced research and clinical operations. The Proscia Ready initiative, established to expedite the widespread adoption of digital pathology, offers laboratories the flexibility to choose from a range […]

Medicine

Emmes submits Duchenne video assessment qualification plan to FDA

The company has officially submitted its Duchenne Video Assessment (DVA) qualification plan to the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) for thorough review. This submission marks a significant moment not only for Duchenne muscular dystrophy (DMD) research but also for the utilization of video assessments as primary endpoints […]

Medicine

New innovation hub launched by RSSL

This dedicated platform aims to bolster small- and medium-sized biotech organisations by providing them with essential resources and support to expedite the development of cutting-edge products. Jacinta George, managing director of RSSL, expressed the company’s vision, stating: “Our goal is to drive vital research and support innovation across the entire life science sector.” The Innovation […]

Medicine

Radboud University – finding the best way to diagnose rare diseases

Deploying genomic technologies helps researchers to better understand the causal mechanisms of diseases improving the accuracy of diagnoses which can help offer patients and their families a possible direction for the future. According to the US National Institute of Health, an estimated 7,000 rare diseases collectively impact between 3.5% to 5.9% of the global population. […]

Medicine

First participant dosed in phase 1 clinical trial for RXC008

The company focuses on discovering and developing small-molecule, targeted therapeutics for the treatment of fibrotic disease and cancer. RXC008 is a wholly owned gastro-intestinal (GI) targeted Rho-associated coiled-coil containing protein kinase (ROCK) inhibitor, being developed as a potential first-in-class treatment for patients with fibrostenotic Crohn’s disease. The primary objective of this first-in-human study is to […]

Medicine

Global biotech, Lifebit, achieves significant milestone

The company says this achievement signifies a major advancement in research and development capabilities within the pharmaceutical industry, driven by the federated data partnerships forged by Lifebit. In an era where traditional drug development processes are characterized by sluggishness, exorbitant costs, and inefficiency, Lifebit says its milestone is a beacon of hope. The company says […]

Medicine

Biogen’s positive step for ALS and neuromuscular disease patients

As a result, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Qalsody (tofersen). This recommendation is for the treatment of adults with ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If approved by the European Commission (EC), Qalsody will mark […]

Medicine

ICON’s Kathleen Mandziuk drug development journey

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Survey uncovers several critical factors motivating physicians

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join our panel of industry experts

Gone are the days when oral methods were the primary means of administering medication. Today, continuous innovations have expanded the arsenal of delivery methods to include implants, patches, syringes, and various solutions for transdermal, topical, and oral systems. These advancements not only cater to diverse health needs but also address the challenges posed by an […]

Medicine

Genuinely exciting phase 3 results for CymaBay’s seladelpar

CymaBay Therapeutics, Inc., a biopharmaceutical company focusing on innovative therapies for liver and chronic diseases, recently (Feb 21) announced the publication of detailed results from the RESPONSE phase 3 trial in The New England Journal of Medicine (NEJM). The trial evaluated seladelpar, an investigational agent and the only potent, selective peroxisome proliferator-activated receptor delta (PPARδ) […]

Medicine

uMotif and MoCA collaborate to deepen commitment to CNS research

This collaboration aims to streamline the process of capturing cognitive function and eCOA/ePRO data, marking a significant milestone in the field of neurological research. uMotif CEO Steve Rosenberg. In announcing the partnership with MoCA Cognition, uMotif CEO Steve Rosenberg explained: “The goal is to bring sponsors, CROs, sites and patients the combined power of modern […]

Medicine

Verisense Health adopts Datavant’s data connectivity platform.

The digital health technology and data company made the announcement last week (February 6) that by using the platform, it can link its digital health panel to other real-world data (RWD) sources and further progress objective, digital health research. Verisense Health’s panel captures participants’ longitudinal, raw, wearable sensor data, together with their patient-reported outcomes data. […]

Medicine

Artax announces first patient dosed in psoriasis treatment trial

According to the National Instituye of Arthritis and Musculoskeletal and Skin Diseases, psoriasis is a chronic, long-lasting disease in which the immune system becomes overactive, causing skin cells to multiply too quickly. Patches of skin become scaly and inflamed, most often on the scalp, elbows, or knees, but other parts of the body can be affected […]

Medicine

Rare diseases interview with Clincierge’s CEO, Scott Gray

It was created by The European Organization for Rare Diseases (EURORDIS) to bring together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers and their families. In advance of the day, OSP spoke to president and CEO Scott Gray, of Clincierge, a patient logistics management company about treatments, collaborations and the […]

Medicine

AstraZeneca’s Tagrisso approved as an important new treatment option

AstraZeneca’s small molecule Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 phase 3 trial published in The […]

Medicine

Doctor at Mendel AI invents a Google for medical records

Going many steps further than just reshaping technology, Dr Karim Galil has been a big part of creating a platform likened to the ‘Google for medical records’. Throughout modern medicine, the journey towards innovation and progress often stems from personal experiences and the desire to end human suffering. Driven by a profound understanding of the […]

Medicine

From Principal IRB to Univo

It is a next-generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies. The company is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials. At last week’s SCOPE Summit […]

Medicine

OVID Health’s initiave rewarding companies’ patient-centricity launches

Health communications consultancy, OVID Health made the announcement today (February 22) that the only Patient Partnership Initiative (PPI) is marking its half decade of the program that shares and celebrates best practices in partnership working towards raising standards across the whole industry. “We are thrilled to reach this milestone of the fifth anniversary of the […]

Medicine

NICE guidance recommends GSK’s Omjjara as treatment option

It can also be used as a treatment for symptoms in adult myelofibrosis patients with moderate to severe anaemia. Myelofibrosis, a rare blood cancer characterized by bone marrow scarring, affects approximately 1,970 individuals across England, Wales, and Northern Ireland. Momelotinib marks the first JAK-inhibitor treatment available in England and Wales for both newly diagnosed and […]

Medicine

Clerkenwell Health’s psychedelic drug trial seeks participants

With treatment-resistant depression, standard solutions aren’t enough. They might not make an impact or your symptoms may only improve temporarily. Now, an international clinical trial is investigating a novel synthetic formulation of the psychedelic substance 5-MeO-DMT, also known as Mebufotenin, for Treatment Resistant Depression (TRD). The trial has now expanded into a new London location […]

Medicine

Women in Science: Sygnature Discovery’s Jane Kendrew

She is now director of translational oncology, at Sygnature Discovery. OSP interviewed Jane to find out more about her career journey – from school to where she is now. Could you give us an overview of your work? As a department, we work with academics, biotechs and large pharma to support critical aspects of their drug […]

Medicine

Florence Healthcare and Slope join forces to strengthen processes

The companies say uniting will address research site demand for end-to-end solutions to increase efficiencies across all trials. Slope is a global clinical trial execution platform for sites used by more than 75% of NCI-designated cancer centers for inventory and sample management. Florence Healthcare is a site enablement platform used by over 18,000 connected research […]

Medicine

Arvinas doses first patient with previously undruggable disease

Arvinas Inc. is using its first oral PROTAC, or PROteolysis-TArgeting Chimera, protein degrader in development to treat neurodegenerative diseases. In preclinical studies, the ARV-102 PROTAC, has been shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2) which is a large multidomain scaffolding kinase. Increased activity and expressions of LRRK2 is […]

Medicine

Innovative Trials partners with Oliver Patch Project for trial retention

Brian Burkhardt began the Oliver Patch Project in 2020 after his son, Oliver, was diagnosed. Children going through treatment can receive regular patches, uniquely designed by artists, to keep them motivated and focused on staying positive throughout their treatment journey. More than 35,000 patches have provided support to thousands of children and teenagers in each […]

Medicine

AstraZeneca’s Tagrisso approved as an important new treatment option

Medicine

Phesi celebrates 100 million global patient data milestone

The company, a provider of patient-centric data analytics made the announcement today (February 6), that this unparalleled volume of data will allow sponsors to access data on patients with more than 4,000 indications, plan more successful trials, and stimulate clinical development activity with a high degree of accuracy. The company says that with such a […]

Medicine

Pharmacies in crisis need Charac’s digital help

Thanks to an injection of funds from private equity firm, Traditum, funds raised are now around the £4 million mark following three earlier funding rounds. The company plans to further enhance its online platform for independent pharmacies and accelerate its growth in the UK and internationally. In January, the government and NHS England launched The […]

Medicine

How Stella Vnook is ‘infusing innovation’ into cell therapies with Likarda’s technology

Having spearheaded the development of companies focused on CAR-T, CAR-NK, and gene-editing technologies, Vnook encountered challenges with CAR-T efficacy on solid tumors, where NK and T cells struggled to maintain their intended targets. Now, Stella runs a company which she believes is able to tackle that exact issue. At Likarda, Vnook leads a team dedicated […]

Medicine

Artax announces first patient dosed in psoriasis treatment trial

Medicine

Advarra’s single sign-on for sites

Some of the biggest subject areas included overburdened clinical sites along with patient retention. To improve clinical research, these key areas must change. Budgeting and contracting have always been the top burden for sites, but in a new survey, technology jumped to the top for the first time. This is significant. On average, sites are […]

Medicine

dsm-firmenich announces partnership with Zerion for CBD innovation

The company says patients currently have to self-administer large volumes of cannabidiol (CBD) to achieve a helpful therapeutic outcome. The partnership grants dsm-firmenich global access to ZERION AS’s Dispersome technology, developed to significantly increase the bioavailability of oral CBD compared to commercially available CBD oils. The companies say that not only will the collaboration inspire […]

Medicine

New data from Japan shows early resolution of common Covid-19 symptoms

The trial met its primary and key secondary endpoints, making ensitrelvir the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection. The study found that once-daily administration of ensitrelvir led to a statistically significant reduction in the time to resolution of five typical COVID-19 […]

Medicine

Roche pulls plug on camonsertib agreement with Repare Therapeutics

Repare has said that it will take back control its global development and commercialization rights to camonsertib (RP-3500), it says is a potential best-in-class, oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase). Roche notified Repare that, effective from May 7, 2024, it is terminating its agreement for the development of camonsertib following a […]

Medicine

Roche pulls plug on camonsertib agreement with Repare Therapeutics

Medicine

First treatment for Friedreich’s ataxia in Europe granted approval

Omaveloxolone will be the first therapy within the European Union to treat Friedreich’s ataxia (FA) in adults and adolescents aged 16 and over. The company announced yesterday (February 12) that the European Commission has given its approval for the small molecule drug, known as Skyclarys. Sylvia Boesch is the principal investigator of the MOXIe study […]

Medicine

New appointments in the pharma industry so far in 2024

Related tags appointments People on the move Pharma industry Jobs Outsourcing Pharma and BioPharma Reporter breaks down the key people on the move in the pharma industry. Enhanc3D Genomics, Cytomos and Cellular Origins are among the companies welcoming new faces to top jobs.

Medicine

Verisense Health adopts Datavant’s data connectivity platform.

Medicine

IQVIA: Healthcare data regional compliance complexity requires AI, ML and NLP automation

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear.

Medicine

Good news for Hong Kong as colorectal cancer treatment approved

The announcement was made today (January 30) that there was marketing approval by the Pharmacy and Poisons Board of Honk Kong for the treatment of adults with previously treated CRC with Elunate. The drug is a selective oral inhibitor of vascular endothelial growth factor (VEGF) receptors -1, -2 and -3, which play a pivotal role […]

Medicine

Top minds from pharma, academia and tech to sit on ArisGlobal’s new generative AI council

The Global Council is a small and exclusive top-tier group of AI tech, academia, regulatory agency leaders, and the life sciences (pharma) industry, including Microsoft. The group’s remit is to pinpoint and showcase repeatable use cases that will shape the targeted use of next-generation artificial intelligence and machine learning (AI/ML) innovation, particularly in the form […]