The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Source: Drug Industry Daily
Bayer sued Perrigo for allegedly infringing on six patents in its ANDA for a generic version of its acne and rosacea treatment Finacea Foam (azeleic acid). Source: Drug Industry Daily
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two…
RELIEF™ trial demonstrated statistically significant reductions in oral ulcers with apremilast 30 mg versus placebo through week 12. Source: BioSpace
AbbVie today presented new positive results from a Phase 2b dose-ranging study evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis. Source:…
AbbVie presented today new positive results from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab (150 mg) compared to placebo…
Roche will plunk down $1.9M to acquire Flatiron Health, which has previously been backed by GV, as well as Roche. Source: BioSpace
Government officials say they are now certain they know who launched the NotPetya cyberwar that slammed operations at Merck last year. Source: BioSpace
Makena was approved by the FDA in February 2011 and remains the first and only FDA-approved treatment option currently available for pregnant women who have had a prior spontaneous preterm…
Shares of Pacira plunged more than 15 percent this morning after the company revealed the FDA panel's decision. Source: BioSpace