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Latest From Jessica Merrill
The company said it will pull global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after determining regulatory delays would put it too far behind the competition.
Spark's Luxturna is all but guaranteed to reach the US market as the first gene therapy following a unanimous positive FDA advisory committee review. Discussions about cost and value are sure to intensify.
Janssen Biotech's Immunology President Scott White defended the company's Remicade contracting strategy in an interview and outlined why J&J believes it has been unfairly targeted in an anti-competitive lawsuit filed by rival Pfizer.
FDA issued a complete response letter for Mylan's application for a biosimilar version of Amgen's Neulasta. However, Mylan said the CRL does not change its US launch expectations, targeted for late 2018 or early 2019.
FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."
Allergan's Medicare Part D contracting tactics for Restasis have blocked Xiidra from the market, Shire lawsuit claims.