Archive for December 2023

Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile neutropenia after chemotherapy. Source: Drug Industry Daily

This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with several drug approvals in the U.S. and EU. Source: Drug Industry Daily

Apple’s request earlier this week for an interim stay of federal orders to stop selling its watches is hardly an emergency, claims Masimo. Source: Drug Industry Daily

As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and complying with a final rule on TV and radio prescription drug ads, as well as a new draft guidance on clinical trial master protocols. Source:…

The FDA delivered a couple of unwelcome holiday gifts to two hopeful sponsors in the form of Complete Response Letters (CRL) — one for Merck’s chronic cough drug gefapixant and the second for Zealand Pharma’s dasiglucagon, an investigational agent intended to treat congenital hyperinsulinism. Source: Drug Industry Daily

As if lawsuits and plummeting stock prices from its faulty CPAP machines didn’t provide enough bad headlines, Philips now wants customers to pull the plug on one of its magnetic resonance imaging machines due to the potential for an explosion. Source: Drug Industry Daily

Bristol Myers Squibb’s (BMS) $14 billion acquisition of Karuna Therapeutics accelerates the company’s diversification into the neuroscience space with Karuna’s priority asset, KarXT (xanomeline-trospium), leading the way. Source: Drug Industry Daily

Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, according to the Department of Justice (DOJ). Source: Drug Industry Daily

CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Source: Drug Industry Daily

The FDA may allow third-party 510(k) reviews for Emergency Use Authorization (EUA) requests, according to a new draft guidance. Source: Drug Industry Daily