Medicine Archives - Exermarm.com

Medicine

Ethris reports positive phase 1 results for ETH47 mRNA asthma treatment

Munich-based biotechnology company Ethris has announced encouraging topline data from a phase 1 clinical trial evaluating its lead messenger RNA (mRNA) candidate, ETH47. The therapy is intended for the treatment of uncontrolled asthma, a condition where asthma symptoms are frequent and disruptive, often due to a virus infection. Targeting the source of uncontrolled asthma The […]

Medicine

Lantheus acquires radiopharma CDMO Evergreen

The US radiopharmaceuticals giant Lantheus is snapping up the Contract Development and Manufacturing (CDMO) Evergreen Theragnostics as it expands its radiopharmaceuticals business. The deal, which is expected to close in late 2025, is intended to absorb Evergreen’s manufacturing capabilities and radiopharmaceutical pipeline. One of the star attractions is the diagnostic imaging compound Octevy, which is […]

Medicine

Novo Nordisk reports 22% weight loss with amycretin

Novo Nordisk has reported weight loss effects of up to 22% in patients who received a weekly subcutaneous dose of its next-generation weight loss drug, amycretin, over the course of 36 weeks. These topline results show early potential for the drug candidate to surpass the efficacy of Eli Lilly’s Zepbound (tirzepatide), one of its major […]

Medicine

Manas AI launches with $24.6 million seed round

The round was led by the US venture capital (VC) firm General Catalyst Partners with participation from compatriot VC Greylock Partners in addition to strategic investors. Manas will use the proceeds to scale up its AI technology and drive ahead its drug pipeline programs. Manas AI is one of many startups gunning to address the […]

Medicine

Applying data to real-world challenges

Head of solution value at One2Treat, Émilie Barré shares her journey to date with Outsourcing-Pharma. Could you give us an overview of your work? I have recently been promoted to head of solution value at One2Treat. In this new role, I’m ensuring the development of our software solution and strategic services are fully aligned with […]

Medicine

The largest pharma acquisitions of 2024

Compared to the previous years, 2024 has been a relatively slow year for mergers and acquisitions in the pharmaceutical space. The largest acquisition of 2024 doesn’t nearly match Pfizer’s acquisition of Seagen for $43 billion in 2023, or Amgen’s Horizon buyout for $27.8 billion in 2022. In contrast, the year 2025 has already started strong, […]

Medicine

Arctic therapeutics secures funding for groundbreaking dementia and acne treatments

Arctic Therapeutics announced this week that it has raised €26.5 million, a sum bankrolled by investors including the European Innovation Council (EIC) Fund, the Icelandic investment firm Kaldbakur and the strategic player Sanos Group. The company will use the proceeds to carry out a pivotal phase 2b/3 trial of its lead candidate program AT-001, an […]

Medicine

Trial shows high-dose Wegovy can increase weight loss effects

Results from the STEP UP trial show that a high-dose formulation of Wegovy can significantly increase the weight loss effects the drug is known for. Novo Nordisk has announced topline results from the phase 3b trial STEP UP, which investigated the effects of two doses of Wegovy (semaglutide) in over 1,400 patients over the course […]

Medicine

BioCina and NovaCina join forces in merger

Australian contract development and manufacturing organizations (CDMOs), BioCina and NovaCina, have merged in a move to pool their biologic and small molecule production expertise and infrastructure. BioCina, which specializes in process development and manufacturing for microbial, plasmid DNA, and mRNA-based treatments, began its life as Bresagen, a spinout of the University of Adelaide, Australia, in […]

Medicine

AI proving critical in clinical trial design

We ran a Q&A With Michael Young, co-founder of Lindus Health on the challenges of 2024 and the company’s goals for 2025 Achievements and milestones What are the most significant milestones your company achieved in 2024, and how have they impacted your organization or the industry? The most important thing is the trials we’re running […]

Medicine

Spotlight on patient centricity in clinical trials

We ran a Q&A with John Clarke, associate director in patient recruitment at Innovaderm on the changing landscape of patient centricity in terms of clinical trials and how the industry can navigate the evolving regulatory expectations around that. Regulatory expectations How are new regulatory guidelines shaping the way clinical trials are designed to prioritize patient […]

Medicine

Medable Showcases AI-Powered Innovations at SCOPE 2025

Stakeholders across the clinical trials and digital health industry will be gathering next month in Orlando at the Summit for Clinical OPS Executives (SCOPE) 2025. With decentralized clinical trials increasingly gathering attention in the pharmaceutical industry, accompanied by rapid market growth, advancements in this area will be one of the major topics of discussion during […]

Medicine

Tech key to accelerating clinical trial outcomes

Ashley Davidson, vice president of sponsor and tech strategy at Advarra, discusses her outlook for this year’s edition of the SCOPE summit. The global market for clinical trials is expected to grow to over $106bn by 2032, but stakeholders in this industry face increasingly challenging obstacles, including regulatory hurdles, talent shortages and clinical studies becoming […]

Medicine

WCG’s outlook for SCOPE 2025

As pharmaceutical pipelines and R&D investments expand worldwide, the global market for clinical trials is projected to grow by almost 9% per year from $48.2 billion in 2023 to $73.2 billion in 2028, partly driven by soaring demand for outsourced trial providers. However, clinical trial providers are facing challenges in completing trials efficiently, including long […]

Medicine

Patient Perspectives and Multidimensional Assessments

The evolution of clinical trials is being driven by an increased focus on patient perspectives and innovative statistical methodologies. Regulatory agencies are pushing for trials that better integrate patient needs, fostering more effective and inclusive treatments. Companies like One2Treat are leveraging this momentum, using advanced tools and expertise to streamline trial design and ensure real-world […]

Medicine

Johnson & Johnson acquires Intra-Cellular Therapies in $14.6bn deal

Johnson & Johnson has entered an acquisition agreement with drug developer Intra-Cellular Therapies priced at $14.6bn, positioning the deal as one of the largest seen in the pharmaceutical industry in the past year. Founded in 2002, Intra-Cellular Therapies develops innovative treatments for complex psychiatric and neurologic diseases, with a scientific platform based on the work […]

Medicine

Scope Summit 2025 award finalists announced

As the Cambridge Healthtech Institute (CHI) celebrates its 16th annual Clinical Ops Executives (SCOPE) Summit in Orlando, Florida, USA, next month, two awards, one for site innovation and another for patient engagement, have released their shortlisted finalists who will battle it out for the winner and runner-up positions. Recognizing Site Innovation in Clinical Trials For […]

Medicine

Anthem Biosciences plans IPO worth $397m

As India’s contract manufacturing and development organization (CDMO) is set to double in the next decade, Anthem Biosciences is planning to raise 33.95 billion rupees ($397m) in an initial public offering (IPO). Anthem expects to list its shares on the BSE (formerly the Bombay Stock Exchange) and National Stock Exchange of India, according to a […]

Medicine

Verdiva Bio’s launch is backed by financing of over $410m

The company’s launch is backed by an oversubscribed Series A round of $411m co-led by Forbion and General Atlantic. RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures and LYFE Capital also participated. Verdiva intends to pioneer next-generation oral and injectable treatments for obesity and other cardiometabolic disorders with first-in-class or best-in-class potential. A particular […]

Medicine

Denali’s ALS Drug DNL343 Misses Key Trial Endpoint

Denali Therapeutics has announced topline results from the phase 2/3 Healey ALS Platform Trial, which evaluated the effects of its drug candidate DNL343. The study did not meet the primary efficacy endpoint of slowing disease progression in comparison with a placebo, as measured using the ALS Functional Rating Scale-Revised (ALSFRS-R). What is ALS? Amyotrophic lateral […]

Medicine

Orbis Medicines bags €90 million Series A

Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, the assets and wealth manager of the Novo Nordisk Foundation. The company is developing treatments based on a class of drug called macrocycles – compounds with a ring-like structure. While macrocycles have yielded blockbuster drugs such as the fungal-derived immunosuppressive drug cyclosporine, […]

Medicine

Bremelanotide: Promising Diabetic Nephropathy Treatment

Palatin Technologies has announced topline results for the phase 2b Breakout study, which evaluated the effects of bremelanotide in patients with type 2 diabetic nephropathy. This condition is a severe complication of diabetes and the leading cause of renal failure in end-stage renal disease, however, there is currently no treatment that can achieve a complete […]

Medicine

Gilead taps into Terray’s AI-based drug discovery

According to the terms of the deal, Gilead will select a set of drug targets and Terray will discover and develop small molecule drugs that bind to them. Gilead has the option to exclusively license compounds in the deal and take on their development and commercialization. In return, Terray will receive an undisclosed upfront payment […]

Medicine

Brazil’s Nintx bags $10m for plant-based drugs

Founded by a team of scientists and healthcare specialists in 2021, Nintx harnesses compounds from Brazil’s world-famous plant ecosystems to develop treatments for complex, multifactorial diseases such as metabolic, immunological, cancer, and brain disorders. The startup unearths disease targets via data-focused technologies that simulate the gastrointestinal system and map out networks of proteins, the human […]

Medicine

AbbVie acquires Nimble for oral peptides

AbbVie and Nimble Therapeutics have announced an acquisition deal in which AbbVie will gain ownership of the company’s pipeline of oral peptide candidates. As part of the $200 million agreement, AbbVie will also acquire Nimble’s proprietary technology platform for peptide synthesis, screening, and optimization. Nimble Therapeutics was founded in 2019 as a spinout of Roche, […]

Medicine

General Inception acquires Enable Medicine

The company creator General Inception (GI) has acquired Enable Medicine to pool its know-how regarding drug development and the biotech ecosystem with the latter’s biological data offerings. A lot of biological data is fragmented and siloed away, making it difficult to harness for discovering new classes of drugs. To tackle this issue, Enable is building […]

Medicine

Noema Pharma Secures $147M to Advance CNS Disorder Treatments

Noema Pharma has announced an extension of its series B financing round, bringing the total raised up to $147 million (CHF 130 million). The round extension has seen venture capital firm EQT Life Sciences join the Swiss company’s existing investors, which include Forbion, Jeito Capital, Sofinnova Partners, and Gilde Healthcare among others. The funds will […]

Medicine

Eli Lilly expansion set to add 750 skilled jobs to Wisconsin site

Shortly after acquiring a manufacturing site in Wisconsin, Eli Lilly intends to expand it to boost its production of injectable products, including diabetes and obesity drugs Mounjaro and Zepbound. Eli Lilly has announced a $3bn expansion of its manufacturing facility in Kenosha County, Wisconsin, in the context of the growing demand for its diabetes and […]

Medicine

AbbVie set to file for FDA approval on tavapadon

Pharma company, AbbVie, reports that its D1/D5 partial agonist, tavapadon, has met the primary and secondary endpoints in a pivotal Phase 3 trial. The trial, called TEMPO-2, evaluated the investigational drug as a flexible-dose monotherapy for individuals with early Parkinson’s disease. Tavapadon is the first partial agonist of the dopamine receptors D1/D5, helping to activate […]

Medicine

PTC Therapeutics boosted by Novartis rights deal for Huntington’s program

PTC Therapeutics announced this week that it has made a deal with Novartis for global rights to its oral Huntington’s disease candidate PTC518, a splicing modifier of the huntingtin protein HTT. The drug is designed to cross the blood–brain barrier and lower levels of the mutant HTT protein, which developers hope will significantly improve outcomes […]

Medicine

Investment in radiopharmaceuticals is ramping up

Investment in radiopharmaceuticals is ramping up as big pharma shows a growing appetite for this promising drug modality. Radiopharmaceuticals see radioactive isotopes being delivered into a target, typically a cancer cell, to kill it. While they have existed for decades, interest in this drug modality was originally limited due to the elevated risk of side […]

Medicine

Mitsubishi and Dewpoint team up to tackle ALS

The pharma arm of Mitsubishi Chemical Group has launched a collaboration with US-based Dewpoint Therapeutics to co-develop a preclinical-stage treatment for the neurological condition amyotrophic lateral sclerosis (ALS). As part of the deal, Dewpoint can expect an undisclosed upfront payment from Mitsubishi Tanabe Pharma Corporation (MTPC) in addition to undisclosed “near-term” developmental milestone payments, with […]

Medicine

Körber absorbs Bähren to expand pharma packaging

The pharmaceutical business unit of the German giant Körber has snapped up the compatriot label and leaflet supplier Wilhelm Bähren GmbH & Co as the pharmaceutical packaging market is set to double in the coming decade. Körber’s pharmaceutical segment offers products to store and transport drug products, including folding boxes, sustainable packaging and secure boxes […]

Medicine

Novocure’s TTFields therapy boosts survival in pancreatic cancer

Swiss oncology specialist Novocure has announced positive topline results from the PANOVA-3 phase 3 clinical trial, which evaluated the use of tumor treating fields (TTFields) therapy in combination with the chemotherapy drugs gemcitabine and nab-paclitaxel. The trial met its primary endpoint of a significant improvement in median overall survival in patients with unresectable, locally advanced […]

Medicine

Tech-driven solutions for patient access

While these sites are important for clinical research, they make patient recruitment challenging. Many participants are forced to travel to these locations for recurring visits, and many face obstacles, such as taking time off work, childcare, or living in remote locations. With the rise of technology (and AI), decentralized clinical trials are becoming more popular […]

Medicine

Overcoming nonspecific binding challenges in PK assays

However, nonspecific binding (NSB) can hinder PK assays, impacting their accuracy and reliability. Fortunately, there are strategies and best practices to counter this issue. NSB occurs when analytes in a solution bind to a solid surface. This can happen at various stages of PK assays and can potentially skew results by affecting a formula’s dosage […]

Medicine

Diabetes prevention – Eli Lilly’s Tirzepatide shows 23% weight loss

Eli Lilly has released detailed results from the SURMOUNT-1 phase 3 trial, where over 1,000 obese or overweight prediabetic participants were followed over the course of 176 weeks, making it the longest study to date of tirzepatide. The data shows that weekly injections of tirzepatide significantly reduced the risk of progression from pre-diabetes to type […]

Medicine

AstraZeneca invests $3.5BN to boost US manufacturing power

With around $2 billion of the investment dedicated to creating more than a thousand U.S. jobs, AstraZeneca is looking to expand R&D and manufacturing facilities in states including Massachusetts, Maryland, and Texas dedicated to specialty manufacturing, biologics and cell therapies. The £158.7 billion ($200.8 billion) market-cap player is among the top ten biggest pharmaceutical companies […]

Medicine

Phase 3 success for AstraZeneca prostate drug

AstraZeneca has reported positive results from the CAPItello-281 phase 3 trial, which evaluated Truqap (capivasertib) in combination with Johnson & Johnson’s Zytiga (abiraterone) and androgen deprivation therapy (ADT) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). The combination therapy showed significant improvements on its primary endpoint of radiographic progression-free survival (rPFS) of […]

Medicine

FDA grants orphan drug designation to CervoMed’s dementia drug

The US company CervoMed announced yesterday that the FDA has granted Orphan Drug Designation to its oral investigational small molecule drug, Neflamapimod, for the treatment of frontotemporal dementia. The FDA’s decision is on based promising results from the company’s Phase 1 and 2 studies. Frontotemporal dementia is a rare neurological condition affecting approximately 50,000 to […]

Medicine

Portugal’s Hovione builds spray drying capacity in US and Ireland

Spray drying involves converting pharmaceutical liquid solutions into tiny droplets that are rapidly dried with hot gases such as nitrogen. This turns medicinal products into fine powders that can be easier to take as inhalable or oral formulations, especially for compounds that are hard to dissolve in water. Hovione’s latest investment, whose value is undisclosed, […]

Medicine

Adragos Pharma snaps up Baccinex to expand CDMO network

Founded in Munich in 2020, Adragos’ global manufacturing sites were acquired from other players including Haupt Pharma Livron, LAW Pharma, Sanofi and Fresenius Kabi. They offer a range of services including drug development, manufacturing, and supply chain management. The acquisition of Baccinex, which specializes in clinical trial supplies and smaller-scale commercial production, is designed to […]

Medicine

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What’s new at leading trade publication Outsourcing Pharma

Medicine

Decentralized clinical trials market expected to grow to $25BN

According to a recent report by Business Research Insights, the total size of the global decentralized clinical trials market was $7.14 billion in 2023, a figure that is projected to grow to $8.19 billion by the end of 2024. The report forecasts that the decentralized clinical trials market will continue growing to reach $24.97 billion […]

Medicine

Equity boost and partnership aim to accelerate GEMS platform’s efficiency

NVentures also participated in the company’s $200 million Series B last August. This strengthened collaboration is aimed at advancing Genesis’ capabilities to tackle complex and previously undruggable disease targets through optimized AI technologies.The collaboration centers on advancing Genesis’ computational efficiency, with NVIDIA bringing specialized expertise to enhance the GEMS platform’s neural network performance, particularly in […]

Medicine

How eCOA/ePRO is transforming clinical trials

eCOA and ePRO (electronic patient-reported outcome) technology are transforming clinical trials, offering streamlined processes for patients, sites, and sponsors. In this Q&A, Steve shares how user-centric design, emerging trends, and collaboration are shaping the future of clinical research. The clinical trial landscape continues to evolve rapidly, and eCOA and ePRO are at the forefront of […]

Medicine

C Ray Therapeutics $100M to improve RDC technology platform

C Ray Therapeutics has announced the completion of a series A+ financing round, which has exceeded the $100 million mark. The round was co-led by Shenzhen Capital Group and TaiLong Capital, with participation of GL Ventures, 3SBio, Guanghua Wuting among others. Headquartered in Chengdu, China, C Ray Therapeutics specializes in the development of radionuclide drug […]

Medicine

Promising phase 2 results for Eli Lilly’s Muvalaplin

Yesterday, Eli Lilly and Company revealed promising Phase 2 results for its investigational small molecule drug, Muvalaplin, against cardiovascular events. The drug met its primary and secondary endpoints at 12 weeks, revealing a reduction of lipoprotein(a)– Lp(a)– levels by up to 85% in adults with high risk for cardiovascular events. Muvalaplin selectively inhibits Lp(a), a […]

Medicine

Chemistry passion to industry leadership

Now the Global market development manager at Phenomenex, she thrives on connecting insights with solutions, all while channeling the wisdom of her science-loving microbiologist father. Tran’s story is a testament to curiosity, perseverance, and finding unexpected paths beyond the lab. Could you give us an overview of your work? I serve as the biopharma market […]

Medicine

From lab to leading biopharma innovation

Now leading the Biopharma product management team at Phenomenex, she brings a problem-solving mindset honed by a love of forensic science and analytical chemistry. Her story showcases the power of patience, adaptability, and breaking traditional career molds to find success in a fast-paced, global industry. Could you give us an overview of your work? I […]

Medicine

Samsung Biologics and European pharma company enter major manufacturing deal

The global contract development and manufacturing organization (CDMO), Samsung Biologics, announced this week that it has entered into a collaboration with an undisclosed European pharmaceutical company, signing a series of manufacturing deals worth over $668 million. The company will provide manufacturing services through December 2031. “We are delighted to expand our partnership with the European […]

Medicine

Drug-free pain relief for knee osteoarthritis

Sameer Sabir, CEO and co-founder of Brixton Biosciences, aims to revolutionize pain management. With Neural Ice, the company’s groundbreaking drug-free therapy, Brixton aims to offer ultra-long-lasting pain relief with a simple injection. Targeting knee osteoarthritis as its first focus, this novel technology uses a temperature-based mechanism to disrupt pain-transmitting nerves without addiction risks or systemic […]

Medicine

Pfizer’s HYMPAVZI wins EU approval for hemophilia A and B care

The US big pharma company Pfizer has been granted marketing authorization for its hemophilia A and B treatment, HYMPAVZI (marstacimab), by the European Commission based on positive Phase 3 study results. In the EU, the drug is the first once-weekly, subcutaneous treatment for people with severe hemophilia B, and the first that can be administered […]

Medicine

Icotrokinra ‘best in class oral therapeutic for plaque psoriasis’

The phase 3 ICONIC-LEAD study showed that icotrokinra, a peptide drug that blocks the interleukin (IL)-23 receptor, was able to induce significant clearance of psoriatic plaques. The drug is being developed in conjunction with Johnson & Johnson and Protagonist will earn $115 million as a milestone payment from the big pharma for successful completing a […]

Medicine

Samsung Biologics and European pharma company enter major manufacturing deal

Medicine

Pfizer’s HYMPAVZI wins EU approval for hemophilia A and B care

Medicine

C Ray Therapeutics $100M to improve RDC technology platform

Medicine

Promising phase 2 results for Eli Lilly’s Muvalaplin

Medicine

GHO and Ampersand acquire CDMO Avid Bioservices for $1.1 billion

Under the terms of the merger agreement, Avid Bioservices will be acquired by funds managed by GHO and Ampersand in a transaction valued at $1.1 billion. The acquisition price represents nearly a 22% premium to the company’s average share price for the past 20 days, and over six times the revenues expected in 2025. Based […]

Medicine

Coronado’s CSO champions data-driven innovation in clinical trials

At the helm of Coronado’s scientific strategy, Professor Visser-Rogers envisions a data-driven future powered by innovative methodologies and emerging technologies. Her approach emphasizes not only precision medicine and patient-centric clinical trials but also the critical integration of AI, advanced analytics, and adaptive regulatory frameworks to meet the industry’s pressing challenges. Vision for Coronado Research: As […]

Medicine

Gifthealth partners with United Digestive

Gifthealth has announced a strategic partnership with United Digestive, a leading practice management organization for gastroenterology. This is to enhance patient access and improve preparation processes for gastrointestinal procedures. As a result of this collaboration, Gifthealth becomes the exclusive patient adherence and education platform for United Digestive, marking a significant expansion for the company, which […]

Medicine

Patients prefer telehealth for clinical trials, survey shows

Conducted with 136 US-based participants across multiple health conditions, the survey found that 63% said they would be more likely to join a trial if telehealth options were available. The company suggests this shift could help address logistical challenges, making participation possible without the need for extensive travel or in-person visits. The option to use […]

Medicine

AI-driven Medable Studio speeds digital trial startups

Medable, a provider of clinical development technology, has announced a collaboration with Google Cloud to bring its decentralized clinical trial platform to Google Cloud Marketplace, a digital store for third-party software solutions. This partnership will allow customers to benefit from cutting-edge technology of Google’s cloud infrastructure and artificial intelligence (AI) capabilities. “This alliance provides life […]

Medicine

Overcoming nonspecific binding challenges in PK assays

Medicine

Equity boost and partnership aim to accelerate GEMS platform’s efficiency

This forms part of an expanded partnership to enhance Genesis’ AI-powered drug discovery platform, GEMS (Genesis Exploration of Molecular Space). The new investment follows NVentures’ participation in Genesis’ $200 million Series B funding in August 2023. This strengthened collaboration is aimed at advancing Genesis’ capabilities to tackle complex and previously undruggable disease targets through optimized […]

Medicine

Diabetes prevention – Eli Lilly’s Tirzepatide shows 23% weight loss

Medicine

AstraZeneca invests $3.5BN to boost US manufacturing power

Medicine

Tech-driven solutions for patient access

Medicine

Decentralized clinical trials market expected to grow to $25BN

Medicine

Merck, Abbisko’s oral drug aces phase 3 for rare tumors

According to the topline results, a total of 54% of patients given the treatment saw their tumors shrink compared to just 3.2% in the placebo group, hitting the primary endpoint of the trial. TGCT is a rare condition mainly caused by an overexpression of the protein colony stimulating factor-1 receptor (CSF-1R), which drives the proliferation […]

Medicine

Dexter Tjoa on Tjoapack’s journey and future in packaging

CEO Dexter Tjoa shares insights on the company’s journey, from early barcoding breakthroughs to embracing advanced technologies for patient safety, sustainability, and global compliance. Discover Tjoapack’s pivotal role in transforming the packaging landscape. Outsourcing Pharma’s senior editor, Liza Laws (LL) caught up with him to find out more. LL: Tjoapack recently marked 35 years in […]

Medicine

Axonis raises $115 million to treat epilepsy

Epilepsy is one of the most common neurological conditions in the world, with around 50 million people with the condition. There are a variety of approved medications for epilepsy and pain. but many patients cannot benefit from the drugs or have severe side effects such as depressive mood, psychosis and anxiety, according to Axonis’ website. […]

Medicine

Abzena unveils cell Line and ADC innovations at CPHI 2024

By offering comprehensive, integrated solutions, Abzena aims to streamline drug development processes and minimize risks for customers, helping to accelerate timelines and enhance production. OSP had a catch-up with them after the event to find out how things went. What new products or innovations did your company showcase at CPHI Milan 2024 this year? At […]

Medicine

Veeva’s Tim Davis on overcoming eCOA deployment challenges

Tim Davis, vice president of strategy at Veeva eCOA, had a conversation with Outsourcing Pharma’s senior editor, Liza Laws, and sheds light on how the landscape is changing and what this means for study teams, sites, and overall trial efficiency. In this interview, Davis discusses the hurdles of eCOA, innovative solutions streamlining implementation, and the […]

Medicine

Novo Nordisk signs $285 million deal for a once-monthly Wegovy

Ascendis Pharma has granted Novo Nordisk an exclusive worldwide license to its TransCon technology platform for the development, manufacturing and commercialization of Novo’s products in metabolic diseases, including obesity and type 2 diabetes. The deal also covers an exclusive license in cardiovascular diseases granted on a product-by-product basis. As part of the licensing deal, Ascendis […]

Medicine

Senhwa Biosciences starts trial of drug for rare cancers in children

Silmitasertib, also known as CX-4945, was originally developed by Cylene Pharmaceuticals, a San Diego-based biotech that ceased operations in 2013. Since then, Senhwa Biosciences, which is headquartered in Taiwan but also has a San Diego base gained the rights to the small molecule, first in class, casein kinase 2 (CK2) inhibitor. CK2 is overexpressed in […]

Medicine

Middle School MD fosters youth interest in medical careers

The Palomar Health Foundation recently completed its third annual Middle School Medical Discoveries (Middle School MD) program, engaging local youth in immersive learning sessions aimed at inspiring future healthcare careers. By directly connecting students with healthcare professionals, Middle School MD aims to nurture an early interest in medicine and highlight the crucial role healthcare professionals […]

Medicine

MD Anderson investment supports groundbreaking cancer therapies

Starget Pharma, an Israeli startup developing AI-powered precision therapies for difficult-to-treat cancers, has secured a $5.1 million investment from MD Anderson Cancer Center’s Cancer Focus fund. This latest funding round supports the clinical development of Starget’s unique radioligand-based therapies, designed to deliver targeted radiotherapy directly to tumor cells while sparing healthy tissue. Expected to revolutionize […]

Medicine

Novo Nordisk study – semaglutide reduces hospital admissions

Novo Nordisk has released data from the SELECT phase 3 trial showing that a 2.4 mg dose of semaglutide reduced the number of hospital admissions as well as the overall length of hospital stay for adults with obesity or overweight with previously established cardiovascular disease and without diabetes. Semaglutide is the active compound in Wegovy […]

Medicine

First-line leukemia therapy granted accelerated approval by FDA

Novartis’ Scemblix (asciminib) has received accelerated approval by the US FDA as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive myeloid leukemia in chronic phase (Ph+ CML-CP). The approval of Scemblix is based on results from the ASC4FIRST phase 3 trial, in which Novartis’ drug was compared to all other standard of care […]

Medicine

AI-driven outreach boosts therapy start, adherence rates

A new case study from AllazoHealth demonstrates that a top 10 rare disease pharmaceutical company experienced a 10.4% increase in therapy initiation through AI-driven patient outreach and tailored, multi-channel communications. The study highlights how AllazoHealth’s AI-enabled personalization strategy allowed the company to precisely time and tailor messages to patients, caregivers, infusion centers, and prescribers across […]

Medicine

Labguru ELN integration enhances Thermo Fisher LIMS capabilities

This integration aims to create a unified lab management experience, offering scientists enhanced data traceability, security, and streamlined workflows across a wide range of laboratory settings—from research and development to GXP-compliant environments. We spoke with Dino Kazanis, product manager, and James Swartz, commercial lead for the Labguru integration at Thermo Fisher Scientific, to learn more […]

Medicine

Vicky Marriott on leading with empathy in science and statistics

In an exclusive interview, Vicky shares insights on her career, the challenges she faced, and her passion for inspiring the next generation of women in science. Facing challenges head on, problem solving, and determination led her to become head of statistics at Phastar. She shares how statistics helped her see the real-life applications of mathematics […]

Medicine

Enhancing pharma manufacturing with digital twin technology

From reducing operational costs to enhancing patient outcomes, Stevanato Group is at the forefront of digital transformation in pharma. Digital Twin Technology: How has the implementation of digital twin technology at Stevanato Group enhanced your manufacturing processes? Can you share specific examples of how it has reduced risks and costs? Data management and AI are […]

Medicine

Anu Codaty’s path to biotech leadership

With a background spanning biotech and executive roles at Medtronic, Anu brings a unique blend of resilience, collaboration, and strategic insight to her role—transforming challenges into opportunities for growth in a traditionally male-dominated field. Could you give us an overview of your work? I am on the leadership team of Aldevron, a leading provider of […]

Medicine

GLP-1 market heats up as companies vie for next-gen obesity drugs

Since the FDA approval of Novo Nordisk’s Wegovy as a treatment for chronic weight management in 2021, followed by the approval of Ozempic the next year, demand for GLP-1 agonist drugs has rapidly grown. So much so that both Novo Nordisk and Eli Lilly, which has two GLP-1 competitors, Mounjaro and Zepbound, have been facing […]

Medicine

Axonis raises $115 million to treat epilepsy

Medicine

NovAliX and Bruker forge alliance to boost drug discovery

This alliance marks a shift in biopharma R&D, with the launch of the Biophysics Institute for Biomedical Research (IBRB), offering top-tier scientific instrumentation and collaborative research support. Bruker’s minority stake in NovAliX, coupled with the collaboration’s focus on advanced analytical tools and biophysical expertise, positions the two companies to reshape the research landscape, particularly in […]

Medicine

Rentschler Biopharma to boost production with new buffer media station

Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) will be increasing its production at its headquarters in Laupheim with the construction of a state-of-the-art buffer media station. The new four-story facility is slated to open by the end of 2027 and be fully operational by 2028. “The new buffer media facility at our […]

Medicine

GSK beefs up US manufacturing with $800 million

GSK is one of the world’s biggest pharmaceutical companies with products ranging from the shingles vaccine Shingrix and the HIV antiretroviral medicine Dovato to general medicines such as the inhaled asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy. The latest investment is GSK’s biggest in the U.S. to date, with the aim of boosting […]

Medicine

Merck acquires Modifi Biosciences in $1.3B cancer drug deal

Modifi Biosciences, a spin out of Yale University founded in 2021, has been snapped up by Merck for $30 million paid upfront, and up to $1.3 billion in potential milestone payments. Modifi focuses on the development of small molecule drugs that target cancer cells with impaired DNA repair. “In founding Modifi Biosciences, we sought to […]

Medicine

NorthStar launches radiopharmaceutical CDMO

Radiopharmaceuticals consist of radioactive isotopes that are chemically attached to small molecules, peptides or protein drugs such as antibodies. These treatments are rapidly gaining traction in the treatment of cancer for their ability to zap tumors with deadly targeted radiation, and they depend on the scalable production of medical isotopes including Copper-67 (Cu-67) and Actinium-255 […]

Medicine

Boston biotech secures funds to advance depression, anxiety drug

Seaport has developed a platform called Glyph designed to enhance efficacy and reduce the side effects of potential drug candidates. The original research behind the platform came from Monash University in Australia. Potential medications developed using Glyph are absorbed like fats in the diet through the lymphatic system. The Series B adds to Seaport’s $100 […]

Medicine

Merck acquires Modifi Biosciences in $1.3B cancer drug deal

Medicine

NorthStar launches radiopharmaceutical CDMO

Medicine

Donanemab Alzheimer’s drug approved by MHRA, rejected by NICE

A new Alzheimer’s treatment, donanemab, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but a draft decision by the National Institute for Health and Care Excellence (NICE) has rejected the drug for use on the NHS. Manufactured by Eli Lilly, donanemab, also known as Kisunla, is designed to slow cognitive decline […]

Medicine

PTC Therapeutics DMD drug misses regulatory hurdle

The EU first gave Translarna a conditional marketing authorization in 2014 for the treatment of DMD, a progressive condition that causes the muscles to weaken, eventually becoming life-threatening. Eligible patients for the treatment are at least 2 years old, are able to walk, and their disease is caused by a so-called nonsense mutation in the […]

Medicine

PTC Therapeutics DMD drug misses regulatory hurdle

Medicine

Women in Science – SCIEX Rebekah Sayers

Find out all about her intriguing journey to where she is now in her role as marketing manager within small molecule omics at SCIEX. Could you give us an overview of your work? One of the things I love about my job is the fast paced and dynamic environment, every day is different and brings […]

Medicine

Acquisition adds late-stage drug candidate with blockbuster potential

Lundbeck and Longboard Pharmaceuticals have announced an agreement for the Danish pharmaceutical company to acquire all outstanding shares of Longboard, in a transaction valued at $2.6 billion in equity value. The transaction is expected to close by the end of the year. The deal will give Lundbeck ownership over Longboard’s pipeline of drug candidates for […]

Medicine

The industry is opening up to techbio – panel highlights

Techbio is a field where the computational expertise of the tech sector and the biological know-how of the biotech sector converge. This leads to applications including the use of clinical and genomic data as well as sophisticated artificial intelligence (AI) algorithms to cut healthcare costs, deliver personalized medicine, and speed up drug discovery. “If you’re […]

Medicine

Jane Koo’s role in advancing cancer therapies at CTMC

With a career spanning monoclonal antibodies and now cell therapies, she expertly navigates complex regulatory landscapes to bring life-changing treatments to patients. Her passion for science, leadership in regulatory strategy, and commitment to advancing cancer cures drive her work every day. Could you give us an overview of your work? CTMC is a unique therapeutics […]

Medicine

Corden Phama – staying on top of manufacturing trends

Outsourcing Pharma caught up with experts from the global CDMO, CordenPharma, to learn how they maintain their competitive edge. Brittany Hayes, Global Platform Director for Highly Potent & Oncology, and Ilia Freifeld, Global Platform Director for Small Molecules at CordenPharma, shared their insights with Outsourcing Pharma at CPHI. How would you describe the current global […]

Medicine

Sanofi halts Denali’s MS drug trial after phase 2 failure

The K2 trial tested oditrasertib’s safety and ability to reduce the blood levels of neurofilament light chain, a biomarker of neuronal damage in multiple sclerosis. However, the trial failed to meet its primary and undisclosed key secondary endpoints, according to a filing. Multiple sclerosis is a degenerative and progressive disorder where the immune system attacks […]

Medicine

Precision dosing expert Sharmeen Roy

With a background in pharmacy and specialized pediatric care, she now bridges bioinformatics with practical, user-friendly tools, empowering clinicians to make patient-specific dosing decisions. Her passion lies in improving patient safety by reducing medication-related errors and driving innovations that directly impact healthcare outcomes. Could you give us an overview of your work? At DoseMe, our […]

Medicine

From researcher to market leader at SCIEX

Now a global market development manager, she plays a pivotal role in shaping solutions for food safety and environmental protection. In this Q&A, Gitte opens up about her inspiring journey, the hurdles she’s overcome as a woman in STEM, and the lessons she’s learned along the way. Could you give us an overview of your […]

Medicine

Enzene targets cost savings and efficiency

The significant advantages it offers include: Large reduction in COGS: By 2025, EnzeneX 2.0 expects to produce 40 kg/1000 L batches at $40/gram, redefining FCCM economics. Lower operational costs and higher productivity can lead to up to 50% reductions in overall cost per gram. Higher Titer Clones: EnzeneX 2.0 maximizes protein yield per cell line […]

Medicine

SGD Pharma to showcase new glass packaging solutions at CPHI 2024

These siliconized vials are designed to protect sensitive, aggressive, and viscous drug products by reducing interactions with the glass and preserving the integrity of the contents. Available in both clear and amber glass, and in sizes ranging from 3ml to 500ml, these vials are suitable for various drug delivery methods, including parenteral, oral, and nasal […]

Medicine

Evaxion AI platform identifies cancer vaccine targets in trials

Danish techbio company Evaxion Biotech has published results showing the outcome of three clinical trials comparing the prediction scores of its AI-Immunology platform with patients’ immunological responses. The AI-immunology platform can identify targets – called neoantigens – for cancer vaccines and predicts the specific immune response of a particular vaccine target against a tumor. In […]

Medicine

AstraZeneca strikes $2 billion deal with CSPC

Dyslipidemia, a condition involving unhealthy levels of cholesterols and other fats in the blood, is a major risk factor in cardiovascular diseases, which make up the world’s biggest killer with 17.9 million deaths per year. While there are treatments for dyslipidemia, they are not sufficient to control the blood levels of low-density lipoprotein cholesterol, or […]

Medicine

FDA clearance to start clinical trials with new obesity drug

Antag Therapeutics has announced that the FDA has accepted the investigational new drug (IND) application for its lead drug candidate, AT-7687. This will enable Antag Therapeutics to initiate a phase 1 clinical trial to evaluate the small molecule drug candidate in both healthy lean and healthy obese individuals. The study will also explore the combination […]

Medicine

Third-generation lung cancer therapy commercialized

Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (Ask Pharm) have announced a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) intended for the treatment of lung cancer. Under the terms of the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China and will receive a […]

Medicine

Will AI live up to its promise and how will it impact global health?

One area it is thriving is pharmaceuticals as it is being used to bring drugs to market faster than ever before. OSP sat down with Melanie Nelson, director of product management, solutions and integrations at Dotmatics, a research and development (R&D) scientific software company to find out where they think AI will take the industry and […]

Medicine

How will the Biosecure Act impact the pharma industry?

But what does the Act mean for the biotech and pharma industry and how can companies best prepare for any impacts on future business? The Biosecure Act was first proposed by the US government late last year due to concerns about national security and how genetic and other biological data could be misused by foreign […]

Medicine

Recipharm bolsters global production facilities

One of Recipharm’s main aims is the expansion of its oral solid dosage and sterile fill & finish services in sites in Europe, the U.S., Israel and India, with the aim to cover all phases of drug development from active pharmaceutical ingredient synthesis to commercial manufacturing. Recipharm began its life in 1995 as Recip and […]

Medicine

Big reveals for dsm-firmenich at CPHI 2024

Located at booth 3B25 (API Hall 3), the company says it will demonstrate its ongoing commitment to advancing the global pharma market. The company aims to continue elevating therapy development – and at this year’s CPHI it will be showcasing its first-to-market CBtru drug product intermediate and taste modulation solutions for enhanced therapy convenience and […]

Medicine

FDA compliance and AI drive growth for Quotient

He will also be explaining how the company is expanding its Translational Pharmaceutics platform into new therapeutic areas like mRNA, and using AI to optimize drug development. With a focus on compliance, innovation, and streamlining processes, he says the company continues to set itself apart in the pharmaceutical industry. We caught up with him before the […]

Medicine

Adragos Pharma and the evolving world of outsourcing

We also delve into the latest trends, the rise of AI and the increasing focus on sustainability. How has the role of contract development and manufacturing organizations (CDMOs) evolved over the last five years? The role of CDMOs has shifted significantly since the onset of the COVID-19 pandemic, with the pharma industry now focusing on […]

Medicine

Symbiosis unveils expanded facility at CPHI Milan 2024

The event provides a great platform for the company to present its newest addition—a 20,000 sq ft facility in Stirling, UK, which the company says enhances Symbiosis’ ability to support biopharma companies with high-quality manufacturing solutions. Colin MacKay, founder and CEO of Symbiosis, shared exclusive insights in a recent interview with Outsourcing Pharma. Symbiosis has long […]

Medicine

Ardena expands bioanalytical and GMP services

The company explains attendees will gain insight into how Ardena’s innovations can streamline drug development for advanced therapies, particularly in oncology and specialized therapeutic areas. OSP spoke to Jeremie Trochu, CEO at Ardena in the build-up to the show. What new products or innovations is your company showcasing at CPHI Milan this year? Ardena will spotlight […]

Medicine

SK pharmteco invests $260M in small molecules

The expansion involves setting up a new facility, which is planned to begin operations in late 2026. The facility, which will include 300 new hires, will have a footprint of 135,800 square feet with eight production trains with an output of tens of metric tons annually. After a difficult period with shocks from the Covid-19 […]

Medicine

Optimizing patient recruitment for faster clinical trials

The success of these trials hinges on finding and enrolling the right patients in a timely manner. Eben Scanlon, chief customer officer at OneStudyTeam, has spent over two decades working in clinical data management and recruitment strategy. In this interview, Scanlon shares insights on how biopharma companies can optimize patient recruitment by collaborating with specialized […]

Medicine

Women in Science – SCIEX Rebekah Sayers

Medicine

LoQus23 raises £35M to advance Huntington’s disease therapy

UK-based company LoQus23 Therapeutics has announced the closing of a £35 million series A round to advance its pipeline of small molecule drugs. The financing was led by Forbion and joined by existing investors Novartis Venture Fund (NVF) and SV Health Investors’ Dementia Discovery Fund (DDF). LoQus23 focuses on developing small molecule drugs that are […]

Medicine

Stevanato to launch Vertiva 10mL on-body system at CPHI 2024

The company says this new platform is specifically designed to administer large-volume injectable therapies, including highly viscous biological drugs, making it suitable for a wide range of conditions such as cardiovascular diseases, oncology, immunology, and pain management. It offers a pre-filled and pre-loaded on-body solution that can be customized to deliver drugs in different dosing […]

Medicine

Sequentia Biotech bags €10m for omics products

Sequentia will use the round winnings to speed up the market introduction of its cloud-based and microbiome-focused healthcare software MICK and scale up the development of its technology offerings. The round was led by Seventure Partners, a French venture capital firm with a history of backing microbiome-focused companies developing disease treatments including Microbiotica and MaaT […]

Medicine

The impact of AI technology in pharmacovigilance

Eric Prugh is the chief product officer at Authenticx, a US-based company that recently launched an AI solution to detect adverse events in conversations to empower pharmacovigilance. Prugh leads product strategy, design, and product marketing at Authenticx and has spent more than 15 years building and scaling software companies. In this Q&A with Outsourcing Pharma, […]

Medicine

An Interview with Tim Martin of Yseop

In an insightful interview, Tim Martin, vice president, product, at Yseop, discusses the company’s recent advancements, notable collaborations, and the significant impact their AI-driven solutions are having on big pharma. He was speaking to senior editor, Liza Laws, during DIA Global in San Diego. From enhancing the efficiency of medical writers to ensuring data privacy […]

Medicine

How does Leal Health’s GenAI transform cancer patient care?

This innovation is poised to transform patient access to cancer care by leveraging advanced AI capabilities to provide personalized treatment options, streamline patient journeys, and enhance overall care. LL: Can you provide an overview of Leal Health’s new GenAI single point of access technology and how it revolutionizes patient access to cancer care? The addition […]

Medicine

How is wearable tech enhancing sleep tracking in clinical trials?

Her insights, captured in the white paper “Closing the Gap in Our Understanding of Sleep Health with Fit-for-Purpose Wearable Digital Health Technologies,” underscore the transformative potential of wearables in providing accurate, real-world sleep data. This comprehensive understanding is essential for improving patient outcomes and supporting regulatory approvals. The white paper is available for download here. […]

Medicine

Tyra Biosciences announces proof of concept data in hypochondroplasia

Tyra Biosciences has released positive results from a preclinical proof of concept study testing its lead drug candidate, TYRA-300, in animal models of hypochondroplasia (HCH). HCH is a type of skeletal dysplasia, a genetic condition that causes the underdevelopment of limbs and other body parts. There are currently no approved treatments for people living with […]

Medicine

Vox Pop Pharma – where will AI be in five years?

Industry leaders give their takes on what else is in store for AI-based tools in the pharma space. AI-powered algorithms have taken many industries by storm and pharma is no exception. For example, many companies are using AI to empower drug discovery and the search for disease targets by crunching reams of literature, helping human […]

Medicine

CEO discusses hormone-free male birth control development

Bakshi shares the innovative approach of YCT-529, the results of their Phase 1a study, and the anticipated impact on reducing unintended pregnancies. This conversation highlights the significance of male contraception in the broader landscape of reproductive health and the challenges faced in pioneering such a transformative solution. What inspired you to develop a hormone-free birth […]

Medicine

Unlocking innovation: Women in Science

In this interview, she shares insights into her role, personal journey, challenges faced, and advice for aspiring women in science. Could you give us an overview of your work?  My role as a global technical developer at Roquette revolves around uncovering new ways to unlock business opportunities through high-quality pharmaceutical excipients. This can look like […]

Medicine

Barriers to opioid treatment access in the US

This Q&A with Sheeba Ibidunni, public health expert and the VP of operations at Sonara Health explores the socio-economic factors fuelling the epidemic, the barriers to accessing life-saving medications, promising government interventions, the impact of state laws, and innovative solutions like telehealth platforms. Can you elaborate on the specific socio-economic factors that you believe are fueling […]

Medicine

Unveiling a key player in ovarian cancer survival

The initiative seeks to understand the crucial role of the omentum, a lesser-known yet vital organ in cancer treatment and overall health. From diagnosis to determination Meg’s journey with ovarian cancer began in 2014, marked by vague symptoms like nausea and abdominal distension. “I looked like I was four months pregnant by night,” she recalls. […]

Medicine

dsm-firmenich unveils advanced CBD drug product intermediate

The IP-protected CBD intermediate brings superior functionality allowing for a higher drug loading compared to currently commercially available products, paving the way for oral dosage forms with enhanced bioavailability. This will enable the development of more convenient and patient-friendly dosage forms – like tablets, including orally disintegrating tablets (ODTs) or chewables – making CBtru a […]

Medicine

Women in Science – Vector Labs’ Pam James

With a lot of familial inspiration, an early love of science developed for Pam James, here we find out how she got to reach her position of vice president. Could you give us an overview of your work? I serve as the VP, Product at Vector Laboratories. I oversee R&D, product management, product marketing, […]

Medicine

Eli Lilly enters $140M partnership with Radionetics Oncology

Eli Lilly has entered a strategic partnership with Radionetics Oncology, a biotechnology company focusing on the discovery and development of targeted radiopharmaceuticals to treat a broad range of solid tumors. As part of the agreement, Eli Lilly will pay $140 million upfront to Radionetics Oncology with the goal of advancing the company’s pipeline of drug […]

Medicine

CatSci acquires Reach Separations to offer chromatography services

The deal was supported by Keensight Capital, a private equity manager focusing on pan-European investments in the technology and healthcare sectors. Headquartered in the UK, and with facilities in the UK and France, Reach Separations provides state-of-the-art chromatography services for the analysis and purification of therapeutics. The company makes use of supercritical fluid chromatography (SLC) […]

Medicine

Tyra Biosciences announces proof of concept data in hypochondroplasia

Medicine

How does the FDA’s Accelerated Approval Program impact patients?

Ginny brings a wealth of knowledge and experience to the table from her diverse background in nursing, law, and regulatory policy. The conversation delved into the intricacies of global regulatory practices and the importance of collaboration in the industry. Liza Laws (LL): Thanks for joining me, Ginny. Could you start by introducing yourself and explaining your […]

Medicine

How is wearable tech enhancing sleep tracking in clinical trials?

Medicine

Esteve invests €100 million in Spanish API manufacturing muscle

The construction project will be financed until 2026 by a €100 million ($108 million) investment by the company. The facilities, slated to begin operations in early 2026, will involve production and service buildings in addition to up to 150 cubic meters of reaction volume. With the new manufacturing facility, Esteve expects its production capacity in […]

Medicine

ALS treatment slows down disease progression by 36%

Results from the PARADIGM clinical trial have revealed that PrimeC, a treatment being developed by NeuroSense Therapeutics, was able to significantly slow down disease progression in ALS patients. The phase 2b clinical trial recruited 68 people living with ALS across Canada, Italy and Israel, who were followed for up to 18 months. ALS patients treated […]

Medicine

Mainz Biomed’s cancer stool test takes on liquid biopsies

In an interview with Biopharma Reporter, Mainz Biomed CEO Guido Baechler explains how his company’s stool test for colorectal cancer compares with well known, multicancer blood tests like Galleri. Early detection blood tests such as Grail’s Galleri typically involve isolating DNA from the blood and deploying machine-learning algorithms to scan the DNA for early signs […]

Medicine

Revolutionizing clinical trials: Yonalink’s game-changing tech

YonaLink, a pioneering company in digital healthcare, is set to change that. In an in-depth interview with senior editor, Liza Laws, Gav Martell, co-founder of Yonalink, shared insights into his journey, the company’s groundbreaking technology, and the promising future of clinical trials. The genesis of Yonalink Gav Martell’s path to Yonalink is a testament to […]

Medicine

The evolution of personalized medicine for reproductive health

Also known as precision medicine, this kind of individualized treatment is designed specifically for the patient and has revolutionized cancer therapies in recent years. These treatments also have massive potential for reproductive health and, by extension, the developmental and reproductive toxicology (DART) field, which studies the toxicological effects on reproductive health and development. The most […]

Medicine

The pharma industry’s commitment to sustainability

These efforts are driven by the need for transparency, compliance, and sustainability in response to pressures from stakeholders, including investors, regulators, and consumers. In this piece, industry experts share their insights on the actions being taken and the challenges faced in this important area. Insights from industry leaders: Nic Nunn-Faron, nonprofit & local government advisory […]

Medicine

FDA greenlights Verona’s game-changing COPD drug Ohtuvayre

This groundbreaking approval is expected to transform the market for patients suffering from moderate to severe exacerbations, particularly those with limited treatment options. Asiyah Nawab, a Pharma Analyst at GlobalData, provides her expert insights on the approval and its implications. “Ohtuvayre, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, has great potential to dominate the market […]

Medicine

FDA greenlights Verona’s game-changing COPD drug Ohtuvayre

Medicine

The top 5 emerging startups fuelling drug discovery with AI

Check out five upcoming AI players attracting investor attention for their potential to speed up drug discovery. Drug discovery is a laborious undertaking that traditionally involves lots of trial-and-error drug screening to arrive at a potential candidate for further development. For this reason, the process can take several years and many millions of dollars to […]

Medicine

ELRIG UK & The Protein Society host drug discovery conference

This collaboration aims to unite experts from various fields to explore how emerging protein science can address the challenges in drug discovery. ELRIG UK, known for its commitment to delivering high-quality scientific conferences and networking events, focuses on innovative research that can transform drug discovery. TPS, an international scholarly society dedicated to advancing protein research, […]

Medicine

Revolutionizing clinical trials: Yonalink’s game-changing tech

Medicine

Will Novo Nordisk’s $4.1BN US investment transform drug manufacturing?

This expansion, one of the largest in the company’s history, aims to enhance the production of injectable treatments for obesity and chronic diseases. This investment will create 1.4 million square feet of production space, doubling the footprint of Novo Nordisk’s existing facilities in North Carolina. The new facility will generate 1,000 jobs, in addition to […]

Medicine

How does the FDA’s Accelerated Approval Program impact patients?

Medicine

Sonara Health’s innovative app enhancing access to methadone treatment

With his background in psychiatry, Michael observed the daily struggles of patients in Opioid Treatment Programs and developed Sonara to offer a more flexible and supportive approach. This groundbreaking solution allows patients to demonstrate responsible methadone use, earn take-home doses faster, and achieve their recovery goals with greater ease. Liza Laws (LL): If you could […]

Medicine

CluePoints’ growth investment from EQT: What’s next?

CluePoints is a cloud-based software platform specializing in Risk-Based Quality Management (RBQM) and data quality oversight in clinical trials. The platform is designed to streamline processes, improve data integrity, and ensure risk compliance, making clinical trials safer and more efficient. The investment by EQT, a firm with a strong track record in healthcare and technology, […]

Medicine

Deep dive – why did IQVIA launch a participant payments service?

IQVIA recognized the intricate challenges associated with participant payments in clinical trials, which often involve cumbersome processes and multiple vendors, leading to delays and dissatisfaction among participants. Jim provides insights into the motivations and objectives behind launching this comprehensive solution. Can you explain the core motivations behind launching IQVIA’s participant payments service? IQVIA recognized the […]

Medicine

Mainz Biomed’s cancer stool test takes on liquid biopsies

Medicine

How are AI and real-world data speeding up drug development?

The panel featured Ariel Berger, executive director of integrated solutions and real-world evidence at Aventura; John Van Hoy, executive director of AI and advanced analytics at PPD; and Gino Pirro, vice president of product and technology at PPD. The conversation highlighted how AI and real-world data are transforming the landscape of clinical trials. Disease models […]

Medicine

EMA’s new clinical trials guideline

This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP had a conversation with Vesta […]

Medicine

Is behavioral science key to patient-focused drug development?

Last year, Astellas Pharma established a behavioral science consortium to perform research aimed at better understanding what matters to patients and their carers, findings that will be channeled into drug development. Health organizations are developing a keen interest in behavioral science too. The World Health Organization (WHO) recently appealed for experts to join its global […]

Medicine

How will Cellibre’s $2M NIH grant revolutionize pharma production?

This first-of-its-kind phase 2 grant will expedite the commercialization of cannabinoid ingredient production via precision fermentation. The funding aims to develop cost-effective active pharmaceutical ingredients for treating conditions such as appetite suppression, obesity, inflammation, and diabetes. Cellibre, established in 2019 by a team of biomanufacturing innovators, is dedicated to creating a sustainable manufacturing company that […]

Medicine

DSP Expansion Adds 200,000 sq.ft. to Boost R&D Capacity

The expansion will introduce 200,000 sq. ft. of additional space, addressing the growing demand for Grade-A facilities amid a rising global appetite for research and development (R&D). The new storage and logistics areas will support over 500 customers, including industry giants such as AstraZeneca, Pfizer, BeiGene, and GE Healthcare. This expansion aligns with Dubai’s strategic […]

Medicine

uMotif revolutionizing clinical trials with innovative eCOA solutions

However, the eCOA/ePRO market has seen minimal innovation since the transition from paper-based forms to digital formats two decades ago, leaving a gap in meeting the escalating demand for improved patient reported outcomes driven by heightened regulatory requirements. Speaking on the pressing need for industry-wide transformation, Steve Rosenberg, CEO of eCOA/ePRO provider uMotif, he said: […]

Medicine

Combogesic IV – a new era of opioid-free pain relief medication?

This new medication, approved by the US FDA in October 2023, combines 1,000 mg of acetaminophen and 300 mg of ibuprofen to address mild to severe pain in adults. The introduction of Combogesic IV offers healthcare providers in the US an innovative and non-opioid option for pain management. The American Society of Anesthesiology (ASA) emphasizes […]

Medicine

How does genetic polymorphism affect Alzheimer’s treatments?

This key study explores the influence of CYP2C9 genetic polymorphisms on the pharmacokinetics (PK) of delta-9-tetrahydrocannabinol (THC) and its active metabolites in Alzheimer’s disease (AD) patients. Titled ‘A study on CYP2C9 polymorphism, in Puerto Rican Alzheimer’s patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol,’ it is accessible at the European Society of Medicine website. […]

Medicine

What are the challenges in signal management in pharmacovigilance?

The conversation delves into the complexities of signal management in the PV landscape, highlighting recent advancements and the challenges faced under stringent regulatory requirements. Dr Buddha shares his expertise on how evolving technologies and methodologies are enhancing the detection, evaluation, and management of drug safety signals, ensuring patient safety and regulatory compliance. LL: The life sciences […]

Medicine

CluePoints’ growth investment from EQT: What’s next?

Medicine

EMA’s new clinical trials guideline

Medicine

How will Thermo Fisher’s new EU Facility impact trials?

This expansion of Thermo Fisher’s clinical trial network in Europe will help foster global clinical trial innovation and provide biorepository storage solutions. Thermo Fisher Scientific Inc., a global leader in serving science, has launched this cutting-edge facility to support pharma and biopharma customers with tailored, end-to-end solutions throughout the clinical supply chain. This includes services […]

Medicine

Lokavant unveils AI solution for clinical trial optimization at DIA

Spectrum supports study teams by providing real-time predictions and control over trial timelines and costs, ensuring successful trials in today’s complex landscape. Clinical trials today are more intricate than ever. Late-phase studies now collect over 3.5 million data points, triple the amount from a decade ago, and must juggle an average of 26 endpoints, including […]

Medicine

How does genetic polymorphism affect Alzheimer’s treatments?

Medicine

Lokavant unveils AI solution for clinical trial optimization at DIA

Medicine

How does genetic polymorphism affect Alzheimer’s treatments?

Medicine

Systech unveils game-changing turnkey solution for pharma rework and aggregation

In a groundbreaking development, Systech, a subsidiary of Markem-Imaje and Dover, has introduced a turnkey manual aggregation and rework solution tailored for pharmaceutical manufacturers, CMOs, CDMOs, re-packagers, and wholesalers.

Medicine

uMotif revolutionizing clinical trials with innovative eCOA solutions

Medicine

Creative Qinesca unveiled at DIA – a game changer

Promising to redefine the landscape with its latest solutions, the company hopes to take center stage, offering advancements in data management and patient engagement. Join us for an exclusive preview of how Qinesca is poised to win over the industry and why this unveiling is the must-see event of the conference. Product and Service Innovations: […]

Medicine

GiftHealth’s vow to enhance patient outcomes

John Romano, president, and co-founder, shares exclusive insights into how these innovations are set to tackle industry challenges and enhance patient outcomes. Can you share any new products or services your company is unveiling at this year’s DIA? The Gifthealth team continues to innovate and develop tools to improve the medication access journey for patients. […]

Medicine

how CluePoints is transforming research

This was to discuss what they describe as the groundbreaking impact of their Sub-population Optimization & Modeling Solution (SOMS). This cutting-edge technology, he says, integrated with advanced artificial intelligence, is poised to transform the landscape of clinical trials. Here’s what you need to know about how SOMS is setting new standards in trial precision, rescue […]

Medicine

path forward is giving sites their own log-in credentials

Advarra is set to reveal solutions tailored to address current challenges in the pharmaceutical and healthcare industries. With the results from the 2023 Advarra Site Survey highlighting the burden of training and use of sponsor technology on sites, it is putting forward solutions such as single sign-on and integrated technology ecosystems to streamline study start-up […]

Medicine

Lokavant unveils AI feasibility solution at DIA 2024

This innovative technology allows study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction. By automatically incorporating ongoing financial forecasting, Spectrum dynamically adjusts budgets based on real data, ensuring accurate modeling and efficient trial management. Product and Service Innovations: Can you share any new […]

Medicine

A year of innovation: Roquette’s US center milestone

The center, envisioned as a hub for groundbreaking research and development in pharmaceutical sciences, has thus far successfully lived up to its promise of fostering innovation and accelerating drug development. To gain deeper insights into the successes and future directions of the US Innovation Center, Outsourcing Pharma had the privilege of speaking with Vinod Tuliani, […]

Medicine

Is Stardog AI the cure for pharma batch delays?

Enter Stardog, an AI and data startup at the forefront of revolutionizing how drugs are brought to market. As pharmaceutical companies navigate the complexities of manufacturing, one major bottleneck emerges: the quarantine process. Batches placed in quarantine can lead to significant delays as plant operators struggle to pinpoint the root cause of issues that prevent […]

Medicine

FDA and CluePoints agreement boosting clinical data quality

FDA and its stakeholders have a vested interest in ensuring the integrity of clinical trial data and the safety of participants while clinical research is being conducted. People taking part in clinical trials can be put at significant risk of harm if clinical research misconduct such as fabrication or omission of data in reporting study […]

Medicine

Enzene Bioscience’s creative approach to biosimilars

He says the strategic expansion into continuous manufacturing facilities aims to revolutionize the accessibility and affordability of life-saving medicines. LL: Could you introduce yourself and share a bit about your background leading up to your role at Enzene? HG: My journey in bioprocessing started with a PhD in biochemistry from the University of Tennessee. I […]

Medicine

Diane Lacroix on Clinical Trials Day

Diane shares her expert insights on how creative data solutions are transforming the landscape of clinical research, enhancing efficiency, and improving patient outcomes. What significance did Clinical Trials Day hold for your company? Each year, Clinical Trials Day is an opportunity for eClinical Solutions to celebrate the people involved in clinical trials and the advancements […]

Medicine

Positive CHMP opinion for Mirum’s Livmarli in PFIC

This endorsement comes from the phase 3 March study showing a highly significant reduction in pruritus severity compared to placebo across all PFIC types. The CHMP’s assessment highlights that Livmarli offers significant clinical benefits over existing therapies. Additionally, the Committee for Orphan Medicinal Products (COMP) recommended maintaining the Orphan Drug Designation for Livmarli in PFIC. […]

Medicine

Shionogi expands infectious disease R&D to the US

The big announcement was made at the BIO International Convention, where top policy and health leaders gathered to discuss the future of pandemic preparedness and antimicrobial resistance. The new lab, established through Shionogi’s group company Qpex Biopharma, is set to boost their capabilities in infectious disease and pandemic preparedness. The new Shionogi Qpex Lab will […]

Medicine

Uncovering the talent pool of AI in Montreal at Mila

Established in the 1990s by a group of professors including the renowned Yoshua Bengio, and Laurent Tillement, OSP was delighted to be invited to visit during a recent trip to Montreal. Tillement explained how Mila has grown rapidly over the last decade to become one of the world’s largest AI research institutions. In a comprehensive […]

Medicine

Revolutionizing drug development: AI’s game-changing potential

Christine Allen, a veteran with 25 years in drug formulation, is at the forefront of this breakthrough. She says Intrepid Lab’s innovative AI-driven platform is poised to transform drug development, drastically reducing costs, and improving success rates. From rapidly optimizing formulations to extending the life of off-patent drugs, this technology, she tells OSP, promises a […]

Medicine

Greenphire wins big at the 2024 MedTech Breakthrough Award

The company says its mission is geared towards enhancing clinical research site performance and participant satisfaction. This prestigious accolade recognizes Greenphire’s outstanding achievements in improving the participant experience through advanced patient-facing solutions. This marks the company’s fifth consecutive win, highlighting its sustained excellence in innovative solutions, client support, and ongoing advancements. The MedTech Breakthrough Awards […]

Medicine

UK’s Celadon shipping cannabis-based medicine to the US

Following the signing of an introductory sales contract with a long-established American business, Celadon has successfully shipped two different medical cannabis products across the pond. This shipment represents the company’s first international commercial supply. The American business is a supplier to various US government departments, and this initial sale has the potential to grow into […]

Medicine

Women in Science – this week Orla Cussen

Coming from Donegal in the northwest of Ireland, where there isn’t much industry to a more than 20 years supporting engineers, she explains how she got from A to B and the challenges and triumphs she encountered along the way. Could you give us an overview of your work? I am the engagement delivery lead […]

Medicine

biggest psychiatric breakthrough in 40 years

Cybin is driven by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches – developing differentiated next-generation psychedelic therapeutics – and treatment regimens to address the unmet needs of patients across a multitude of mental health issues. After receiving just two doses of one of Cybin’s developing drugs – three weeks apart – a […]

Medicine

biggest psychiatric breakthrough in 40 years

Medicine

Asahi Kasei’s $1.1 billion power move

This strategic acquisition, valued at approximately SEK 11.8 billion (around $1.1 billion), aims to make Calliditas a wholly owned subsidiary, significantly boosting Asahi Kasei’s international footprint. With shareholders offered SEK 208 ($20) per share and SEK 416 ($39) per ADS, and major stakeholders already on board, this deal is poised to revolutionize Asahi Kasei’s presence […]

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

Bicycle Therapeutics balance sheet boosted by $555M

The recent financing boosts Bicycle Therapeutics’ balance sheet, bringing the pro forma cash position to approximately $1 billion. This financial runway is expected to extend into the second half of 2027, providing robust support for the ongoing advancement of their clinical-stage pipeline. Kevin Lee, CEO of Bicycle Therapeutics, said: “We are excited to announce today’s […]