Archive for January 2024

The Biden administration and Danco Laboratories, manufacturer of the abortion pill mifepristone, have filed briefs petitioning the Supreme Court to keep wider patient access because restricting the drug would have damaging health repercussions for women. Source: Drug Industry Daily

An Illinois law that targets “price gouging” for generic drugs is the target of a lawsuit filed by the trade group representing America’s generics and biosimilar manufacturers who claim the law is a constitutional overreach that would have Illinois regulating transactions outside that state. Source: Drug Industry Daily

The Canadian government is not happy with the FDA’s decision to allow the state of Florida to import certain Canadian prescription drugs in bulk, and neither is the powerful U.S. pharmaceutical industry trade group PhRMA. Source: Drug Industry Daily

Two significant changes in the FDA’s final guidance on updating ANDA labeling are details on how to obtain information on changes to reference listed drug (RLD) labeling and how to submit revised ANDA labeling. Source: Drug Industry Daily

Novo Nordisk, seeking to remain in the front of the weight loss drug race, has inked a deal with EraCal Therapeutics, a biotech startup, whose small molecule program offers a potential novel mechanism of action for controlling appetite and obesity. Source: Drug Industry Daily

In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). Source: Drug Industry Daily

Less than two months after its announced investigation of secondary T-cell cancers in patients who received chimeric antigen receptor (CAR)-T cell immunotherapy cancer treatments, the FDA is mandating label updates to include a boxed warning, the agency’s most serious drug safety alert. Source: Drug Industry Daily

The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new EU regulations, guidance for working with technology and data and collaborating outside the EU. Source: Drug Industry Daily

Sanofi and Inhibrx, a clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates, today announced a $2 billion agreement for Sanofi to acquire Inhibrx. Source: Drug Industry Daily

The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials. Source: Drug Industry Daily