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The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Read More
The FDA has released a question-and-answer guidance to clarify its policies on inspections, pending drug applications and changes in manufacturing facilities for approved drug products during the COVID-19 pandemic. Read More
The Department of Justice has made another move against a drugmaker in its investigation of an alleged industry-wide kickback scheme, accusing Teva Pharmaceuticals of funneling kickbacks for its multiple sclerosis drug Copaxone (glatiramer acetate) through charitable foundations. Read More
Gilead Sciences has received a complete response letter (CRL) from the FDA for its potential blockbuster rheumatoid arthritis treatment filgotinib, calling for more data from ongoing studies. Read More
Johnson & Johnson (J&J) announced that it will acquire the autoimmune-focused biotech company Momenta Pharmaceuticals for $6.5 billion, expanding its holdings in the area of novel treatments for autoimmune diseases. Read More
BioMarin Pharmaceutical announced that the FDA has declined to approve its investigational gene therapy for severe hemophilia A, valoctocogene roxaparvovec, and the agency wants to see two years of follow-up data from a phase 3 study. Read More
Swiss pharma giant Roche is partnering with Regeneron Pharmaceuticals to ramp up production of the New York-based biotech’s COVID-19 antibody cocktail candidate, REGN-COV2. Read More