Drug companies can streamline the development of new antibacterial drugs for seriously ill patients by applying less rigorous standards of effectiveness and more limited clinical trials than typical, the FDA…
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by…
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Source: Drug Industry Daily
A third-party evaluator should be used to assess the expanded communications program proposed in the next generation of the FDA’s biosimilar user fees, according to BIO. Source: Drug Industry Daily
As part of the Trump administration’s deregulatory push, the FDA has withdrawn nine regulations proposed for the pharmaceutical industry, some in the works for years. Source: Drug Industry Daily
A White House commission on opioid abuse, established in March by executive order, delivered its initial set of recommendations to President Trump, urging him to declare an immediate, national state…
The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Source: Drug…
The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved…
An FDA vaccine advisory panel voted 12-to-1 last Friday to recommend approval of Dynavax’s Hepislav-B in adults for the prevention of hepatitis B. Source: Drug Industry Daily
Pharmaceutical and medical device companies will not get tax breaks after the Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning,…