Bio Pharma Dive
SEPTEMBER 26, 2023
Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.
Worldwide Clinical Trials
SEPTEMBER 26, 2023
In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.
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Bio Pharma Dive
SEPTEMBER 26, 2023
Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.
Pharmaceutical Technology
SEPTEMBER 26, 2023
To optimise autoinjector combination product development, it is crucial for pharma and biotech to partner with device companies that have in-house control over the whole device manufacturing process.
Bio Pharma Dive
SEPTEMBER 26, 2023
Hunting for more metabolic disease drugs, Novo plans to work with Evotec to shape early academic research into new development programs.
Pharmaceutical Technology
SEPTEMBER 26, 2023
Novo Nordisk has signed an agreement with Valo Health for the discovery and development of new therapies to treat cardiometabolic diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 26, 2023
Novo Nordisk A/S and Valo Health Inc. have partnered to use Valo's AI-powered human dataset to discover and develop new treatments.
BioSpace
SEPTEMBER 26, 2023
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
Pharmaceutical Technology
SEPTEMBER 26, 2023
The funding will support the clinical development of the oral SK ion channel inhibitor that was recently evaluated in a Phase II trial.
Pharma Times
SEPTEMBER 26, 2023
Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
SEPTEMBER 26, 2023
Genmab has received marketing authorisation from the European Commission (EC) for TEPKINLY as a monotherapy to treat adults R/R DLBCL
BioSpace
SEPTEMBER 26, 2023
After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.
Pharmaceutical Technology
SEPTEMBER 26, 2023
Novartis has confirmed plans for the spin-off of generics and biosimilars business, Sandoz, following shareholder approval.
Pharma Times
SEPTEMBER 26, 2023
EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate - News - PharmaTimes
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Pharmaceutical Technology
SEPTEMBER 26, 2023
Coherus has also announced the completion of study site inspections by the FDA for the checkpoint inhibitor toripalimab.
Fierce Pharma
SEPTEMBER 26, 2023
Amid a global expansion spree at WuXi Biologics, the company's immunization-focused subsidiary has christened its inaugural CDMO site in China. | WuXi Vaccines launched its first standalone vaccine contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development.
Pharmaceutical Technology
SEPTEMBER 26, 2023
GSK has received approval from Japan’s MHLW for RSV vaccine Arexvy to prevent RSV disease in adults aged over 60 years
Fierce Pharma
SEPTEMBER 26, 2023
As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach. | As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
SEPTEMBER 26, 2023
The Sandoz biosimilar, Tyruko, has been approved for all indications as the reference medication, Biogen’s Tysabri.
Antidote
SEPTEMBER 26, 2023
Recruiting patients for a clinical trial can be a challenging process. Studies show that many patients report having little or no knowledge of clinical trials , and sponsors and researchers often report having difficulties finding and enrolling patients in studies. However, once patients understand more about the medical research process, many individuals do want to participate in a clinical trial.
BioPharma Reporter
SEPTEMBER 26, 2023
BioPharma Reporter and Outsourcing Pharma is keeping you in the know with our most recent round-up of important appointments in the pharma industry - including Veranova, Matica Bio and Aldevron.
Outsourcing Pharma
SEPTEMBER 26, 2023
A rare and incurable blood cancer, associated with an overproduction of blood cells, that can lead to stroke or heart attack, will soon have access to a small molecule Novartis treatment for the condition.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
SEPTEMBER 26, 2023
Soon after cancelling its contract with I-Mab, AbbVie has now also turned its back on a partnership with Berkeley-based Caribou Biosciences that was focused on advancing allogeneic CAR-T therapeutics.
Outsourcing Pharma
SEPTEMBER 26, 2023
A new approach to discovering targets for Alzheimerâs and other neurodegenerative diseases has been presented by Insilico Medicine with the University of Cambridge, UK.
BioSpace
SEPTEMBER 26, 2023
Despite filing respective lawsuits challenging the program, AstraZeneca and Bristol Myers Squibb have decided to participate in the first round of price negotiations under the Inflation Reduction Act.
Fierce Pharma
SEPTEMBER 26, 2023
On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercializ | On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
BioSpace
SEPTEMBER 26, 2023
An FDA advisory committee voted 17-1 on Wednesday that BrainStorm Cell Therapeutics did not demonstrate substantial evidence of efficacy for NurOwn in mild to moderate amyotrophic lateral sclerosis.
Fierce Pharma
SEPTEMBER 26, 2023
As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again. | As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again.
Outsourcing Pharma
SEPTEMBER 26, 2023
Drug discovery will benefit from a virtual artificial intelligence (AI) expert thanks to Opportunity Pharma and OpenEye, Cadence Molecular Sciences joining forces.
Fierce Pharma
SEPTEMBER 26, 2023
It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent attempt at cutting costs.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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