Safety

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.

The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.

Supplement industry trade groups and an attorney offer differing views of impact from layoffs imposed by White House’s “Department of Government Efficiency” reportedly numbering as many as 700. They agree layoffs, reported as some 700 across the agency with its food safety programs particularly hit, will affect FDA’s work, but not on whether it will be able to fulfill its responsibilities.

Recent court cases initiated by the Swiss medicines regulator against “unbalanced” media reporting on GLP-1 drugs for weight loss highlights its zero tolerance for any form of misinformation that compromises patient safety.

The US company has voluntarily halted enrolment in BEACON-IPF of bexotegrast on the recommendation of the trial’s independent data safety monitoring board, leaving analysts puzzled over the drug's prospects for the lung disease.

Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.

Hematologists discussed the still limited treatment options for sickle cell disease at ASH, weighing the risks and benefits of disease-modifying versus curative therapies after the withdrawal of Pfizer’s Oxbryta (voxelotor).

Hematologists’ concerns about hepatoxicity with hemophilia A gene therapies may limit use, but Phase III data for Pfizer’s candidate at ASH show a lower rate of ALT increases than seen with BioMarin’s Roctavian.

Vital discussions are ongoing over which medicines containing per- and polyfluoroalkyl substances should be exempt from forthcoming wide-reaching EU restrictions on these substances.