The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amylyx, ANI, Azurrx, Beyondspring, Capricor, Chimerix, Erytech, Merck, Neuraptive, Novartis, Ortho Dermatologics, Remegen.
Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, COVID-19 EMA Pandemic Task Force, Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FDA, Heads of Medicines Agencies, National Institute for Health and Care Excellence, NIH, Therapeutic Goods Administration, U.S. Cyber Command, U.S. House and Senate, Wuhan Institute of Virology.