Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors.
A divided FDA advisory committee voted 13-10 Nov. 30 that the known and potential benefits of the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, outweighs its known and potential risks. If granted an emergency use authorization (EUA), molnupiravir would become the first take-at-home oral drug in the U.S. to keep mild and moderate COVID-19 infections from becoming severe in high-risk adults.
Glaxosmithkline plc (GSK) tapped Arrowhead Pharmaceuticals Inc. for its foray into nonalcoholic steatohepatitis (NASH), as the pair signed an exclusive global licensing deal (excluding China) for GSK to develop and commercialize phase I/II-stage ARO-HSD, Arrowhead’s RNAi therapy targeting HSD17B13.
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
After Moderna Inc. lowered its revenue expectations earlier this month, the company’s swollen stock price plunged over the next two weeks by more than 32%, signifying that BioWorld’s Drug Developers Index can no longer rely solely on one company to keep industry stocks in positive territory.
Roche Holding AG is walking away from a deal with Atea Pharmaceuticals Inc. to co-develop the COVID-19 oral antiviral treatment AT-527 after the mid-October failure of a global phase II study testing the medicine in non-hospitalized adults with mild or moderate disease missed its primary endpoint. Roche’s decision tosses the rights and licenses back to Atea so it can continue its development and commercialization efforts.
Catalyst Biosciences Inc. decided to stop developing marzeptacog alfa (MarzAA), a recombinant human coagulation factor VIIa variant for treating factor VII deficiency, and sell its hemophilia assets to focus on its complement therapeutics and protease medicines platform.
Technically speaking, the scientific community as a whole cannot say for sure whether and how well Aduhelm (aducanumab, Biogen Inc./Eisai, Co., Ltd.) works. After all, two years after the initial report of the Engage and Emerge data at the 2019 Clinical Trials in Alzheimer’s Disease (CTAD), the full trial data have still not been published in a peer-reviewed publication. Which, of course, is one of the problems with Aduhelm.
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
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