The Philadelphia District Attorney is suing opioid manufacturers and is the first to sue under Pennsylvania’s consumer protection law — making it a public enforcement action on behalf of all…
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
The FDA denied a petition seeking the withdrawal of the AMAG Pharmaceuticals hormone drug Makena (hydroxyprogesterone caproate), which a patients’ rights group argues has possible links to developmental abnormalities. Source:…
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…
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:…
RELIEF™ trial demonstrated statistically significant reductions in oral ulcers with apremilast 30 mg versus placebo through week 12. Source: BioSpace
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…
The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form. Source: BioSpace
This week MA-based real estate firm Calare Properties acquired the land and buildings for $5M. Source: BioSpace