ViiV Healthcare filed a patent infringement complaint against Gilead’s new HIV drug Biktarvy on the same day the combination drug secured the FDA’s approval. Source: Drug Industry Daily
The FDA issued 35 new draft and 22 revised product-specific guidances for generic drugs, including the pain treatment buprenorphine, the skin disorder treatment fluocinonide and the multiple myeloma drug ixazomib…
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly…
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Source: Drug…
A group of non-profits and activist organizations, including the American Lung Association, National Health Council and National Organization for Rare Disorders, urged lawmakers in the House of Representatives not to…
The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January. Source:…
FDA Commissioner Scott Gottlieb offered an update on the agency’s plans to address the opioid epidemic, encourage market competition, and tackle internal agency issues, in remarks Tuesday to the Alliance…
The Federal Circuit backed up a lower court ruling dismissing an AbbVie lawsuit seeking to invalidate a patent it licensed from MedImmune. Source: Drug Industry Daily
Punishments for falsification of medicines in the European Union vary significantly between EU member states, according to a study carried out for the European Commission. Source: Drug Industry Daily
Australia’s Therapeutic Goods Administration issued a survey to drugmakers asking about their pharmacovigilance activities with the intention of using the responses to prioritize inspections. Source: Drug Industry Daily