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Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in the dust, a new drug combo looks promising for multiple myeloma, and Regenxbio hopes to snag an Accelerated Approval for a new rare disease gene therapy. Also, Astra Zeneca is touting “major advance” in treating one type of non-small cell lung cancer. Read More
Par Pharmaceutical, a subsidiary of Endo International, announced a voluntary recall of one lot of treprostinil injection 20mg/20mL due to the potential for the presence of silicone particulates in the product solution. Read More
Human Microbes, a company promoting the value and sale of fecal microbiota transplants (FMT), has received an FDA Warning Letter listing a litany of regulatory violations, including lack of an FDA-approved BLA. Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. Read More
The FDA has adopted an updated guidance from the International Council on Harmonisation (ICH) that provides clarification on how to factor in new and increasingly used data sources, such as social media or patient support programs, when reporting individual case safety reports postapproval. Read More
This edition of Quick Notes reviews Wegovy’s new approval for cardiovascular event prevention, interchangeable approvals for biosimilars for Prolia and Xgeva, Biocon and Janssen’s settlement agreement for a Stelara biosimilar, and a Regeneron drug for inherited high cholesterol in children. Read More
Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Read More
Manufacturers of cyber devices must have a plan to keep those devices secure for the product’s entire lifecycle, and sponsors of nonprescription drugs can include some minor labeling changes on an annual report, according to two new draft guidances issued by the FDA. Read More