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Here are the most relevant search results for "BioPharmaDive" found in our extensive news archives from over 250 global news sources.
In addition to our news stories we have dozens of PubMed Articles about BioPharmaDive for you to read. Along with our medical data and news we also list BioPharmaDive Clinical Trials, which are updated daily. BioPortfolio also has a large database of BioPharmaDive Companies for you to search.
The agency is set to launch a new review tool aimed at reducing the number of cycles of application review.
In submitting ALXN1210, the rare disease biotech used one of its priority review vouchers to hasten an approval decision from regulators.
Electronic diary (eDiary) cards are helping sponsors overcome the unique data collection challenges associated with vaccine trials.
Over the past half year, Roche has spent $6 billion on investments aimed at building a lead in the industry's shift toward more personalized medicine.
The FDA put a halt to the company's Phase 1 trial before it even began.
Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.
While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business.
The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.
The sell-off of the stem cell firm will tighten AMAG's focus on pharmaceuticals and help pay down debt.
Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.
Big pharma extended its string of divestitures and portfolio streamlining this week. Meanwhile, manufacturers can't seem to beat Alzheimer's disease.
The gene therapy continued to show promise in two genetic blood disorders, but questions of durability remain.
The trial win is likely welcome news for Lilly and partner Incyte in light of the drug's narrow and disappointing approval in rheumatoid arthritis.
Securing approval for its river blindness drug also hands Medicines Development for Global Health a coveted regulatory fast pass.
All 450 staff employed at the Sanofi site will transfer over to the Swedish CDMO, which hopes to expand its contract business with the buy.
The generic drugmaker faces another regulatory setback for its copycat version of the blockbuster GSK lung drug.
Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market.
Taiwan Biotech was urged to call in a consultant to remedy the cGMP violations flagged by the FDA.
Inking a deal with Shionogi for rights to SAGE-217, the biotech will earn $90 million upfront just as it preps for a potential market launch of brexanolone.
Designing a processing system to handle high-viscosity BioPharma products can be a demanding process, and there are many challenges to consider. However, the better you understand the nature of these challenges, the better you will be able to optimize your quality and productivity.
CoA Therapeutics, the second subsidiary BridgeBio has rolled out this month, aims to create drugs for diseases linked to coenzyme-A deficiencies.
Two drug distributors and four pharmas have signed onto the MediLedger Project, aiming to create a blockchain-based approach to product traceability.
Uptake of the few copycat biologics launched in the U.S. has been slow. Yet a Leerink analyst expects a typical biosimilar will erode 20% of branded drug sales in the first year post-launch.
The nation's largest drugmakers have yet to voluntarily bring down prices on their drugs as President Trump claimed they would — and recent exchanges with lawmakers signal such reductions may not be coming.
Safety concerns for its lead candidate are forcing the company to abandon development and pursue strategic options.