Medical device product liability litigation can take a number of seemingly unique twists and turns, but the case of Nelson v. Bard took a path that might have been predicted based on FDA-mandated labeling content. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court’s ruling that the instructions for use for a Bard inferior vena cava filter indemnified the company because the IFU listed the very events seen by the patient, undercutting the patient’s claim that Bard had failed to warn of these events.
In the six years since the U.S. FDA issued its final guidance on charging for drugs used under an investigational new drug (IND) application for clinical trials or expanded access, the agency has received several questions about how it is implementing regulations on the matters. To answer those questions, the FDA released a revised draft guidance that, when finalized, will replace the guidance issued in 2016.
Regeneron Pharmaceuticals Inc.’s Inmazeb and Ridgeback Biotherapeutics LP’s Ebanga earned a ringing endorsement from the World Health Organization (WHO) in its first ever guideline on Ebola therapies. In releasing the guideline Aug. 19, WHO officials celebrated the fact that Ebola is no longer “a near certain killer” – provided treatment starts as soon as possible following diagnosis.
Shares of Pharvaris NV (NASDAQ:PHVS) fell 34% Aug. 22 to close at $12.15 after the company reported the U.S. FDA placed a clinical hold on PHA-121, its oral bradykinin B2-receptor antagonist for hereditary angioedema (HAE), citing a review of nonclinical data. PHA-121, which goes after the same target as well-established injectable HAE drug Firazyr (icatibant, Takeda Pharmaceutical Co. Ltd.), is the active ingredient in Pharvaris’ two lead programs: PHVS-416, a softgel capsule formulation, and PHVS-719, an extended-release tablet formulation.
It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Pillar Biosciences, Thermedical.
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Axsome, Celltrion, Krystal, Kyowa Kirin, Menarini, Stemline, Valneva, Verona, Virfor.
A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astellas, Aum, Biocryst, Curis, Genfleet, Junshi, Novavax, Oncopeptides, Otsuka.
RSS
