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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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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). Read More
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. Read More
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. Read More
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. Read More
The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of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. Read More
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More
A boxed warning has been added to the labeling for Prolia (denosumab) based on FDA review of information on the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease. Read More