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Takeda Pharmaceutical subsidiary Baxalta and Bayer have hashed out a settlement that will dismiss a 2019 jury verdict that ordered Baxalta to pay $173 million for infringing on Bayer’s patents for the hemophilia A drug Adynovate, with Bayer agreeing not to pursue the money it is owed. Read More
Eli Lilly said its experimental drug, tirzepatide, reduced blood glucose levels and body weight in type 2 diabetics with increased risk of heart disease more effectively than Sanofi’s blockbuster diabetes drug Lantus (insulin glargine) in a head-to-head phase 3 study. Read More
The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
The FDA clarified in a new guidance released yesterday when it is appropriate for drug sponsors to submit an abbreviated new drug application (ANDA) for a synthetic peptide drug product that references an already approved synthetic peptide of recombinant DNA origin. Read More
The FDA has begun its review of Innovent Biologics’ and Eli Lilly’s biologics license application (BLA) for sintilimab, a PD-1 inhibitor for the first-line treatment of nonsquamous nonsmall-cell lung cancer (NSCLC) alongside chemotherapy. Read More
Continuing investment and efforts to discover and develop novel drugs by small and large pharmaceutical companies drove a record launch of 66 new drugs globally in 2020, with particular success in oncology and rare diseases, according to a new IQVIA analysis. Read More
The House of Representatives on Wednesday voted 402 to 23 to pass bipartisan legislation that would close an orphan drug exclusivity loophole — just one week after the bill was denied passage by House Republicans. Read More
Emergent BioSolutions CEO Robert Kramer said Wednesday that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. Read More