Archive for August 2023

Pharmaceutical companies directly impacted by HHS’ Tuesday announcement of the initial 10 drugs slated for Medicare price negotiations via the Inflation Reduction Act (IRA) have swiftly reacted, with many of them already fighting the law’s provisions in court. Source: Drug Industry Daily

The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Source: Drug Industry Daily

The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization using ethylene oxide (EtO) by March 1, 2024, following the government’s signature on a consent decree that settles a complaint against the EPA filed by multiple groups in December 2022. Source: Drug Industry Daily

Despite customers’ reporting symptoms that included stroke, memory loss, atrial ffibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home electroconvulsive therapy (ECT) device, the company did not submit the required Medical Device Reporting within 30 days to let the FDA know that serious adverse events (SAE) had occurred. Source: Drug Industry Daily

Pfizer announced Monday that it has reopened its Rocky Mount plant and that efforts to restart production are on track to restart production near the end of the year. Source: Drug Industry Daily

Amgen scored a win in its bid to acquire Horizon Therapeutics with the FTC withdrawing from adjudication of its challenge of the deal until Sept. 18, to allow for discussion of a possible settlement. Source: Drug Industry Daily

The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than 160 comments the agency received. Source: Drug Industry Daily

The FDA is seeking public comment on its decision to withdraw accelerated approval for Oncopeptide’s Pepaxto (melphalan flufenamide), after a required postmarketing study showed that the drug plus dexamethasone failed to improve progression-free survival in patients with relapsed or refractory multiple myeloma. Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG). Source: Drug Industry Daily