Now that the U.S. judge overseeing Purdue Pharma LP’s bankruptcy proceedings has conditionally signed off on a $10 billion settlement intended to resolve 3,000 opioid lawsuits filed by states, tribes and local governments, the privately owned drugmaker can take the first steps to transform itself into a public service company owned mostly by the National Opioid Abatement Trust and governed by a new independent board.
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Entos, Harbour, Innovative Cellular, Janssen, Junshi, Medincell, Merck, Neuren, Teva.
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Endosound, Immunolight, In2bones, Intelivation Technologies, Rehabtronics, Tyber Medical.
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, ANI, Genhouse, Gloria, Huya, Innocare, Jazz, Ligand, Medipharm, Medivir, Merz.