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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
Almost half of all pharmaceutical companies had more than 1,000 leaked employee credentials exposed on the deep web in the past three months, and nearly 10 percent of pharma manufacturers are now considered highly susceptible to a ransomware attack. Read More