The 180-day exclusivity for first generics cannot extend beyond the expiration of the patent challenged in the ANDA's paragraph IV certification, FDA said in granting exclusivity to American Pharmaceutical Partners for generic cisplatin even though it was not the first company to submit an ANDA for the drug.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
