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FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has declined to recommend approval of Eisai’s Leqembi (lecanemab) for treatment of early Alzheimer’s disease, citing concerns over the drug’s safety. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes features announcements of Lilly’s acquisition of Morphic, a licensing agreement between SK Biopharmaceuticals and Full-Life Technologies, Agilent’s purchase of Biovectra and Cook Technologies sale of its IVF and ART business. Read More
Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not tested, among other violations. Read More
Despite another attempt by Ipsen Biopharmaceuticals to regain market exclusivity for its injectable neuroendocrine tumor drug Somatuline Depot (lanreotide), an appeals court has ruled once more in favor of the FDA. Read More
This week, the FDA published final guidance on glass vials and stoppers, OTC monograph submissions and real-world data. Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing changes to biosimilars. The agency also announced that it is seeking information and comments on biosimilar product development and host cell proteins. Read More
A federal grand jury in Houston has indicted an Indian national with selling and shipping tens of thousands of dollars’ worth of counterfeit oncology pharmaceuticals into the US. Read More
A supplemental BLA for AstraZeneca’s blockbuster cancer drug Imfinzi (durvalumab) for treatment of nonsmall-cell lung cancer (NSCLC) hit a potential speed bump Thursday in a review by the FDA’s oncology advisory panel of the supporting clinical trial. Read More
In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Read More
Members of the House Committee on Oversight and Accountability grilled the leaders of the nation’s three largest pharmacy benefit managers (PBM) — CVS Caremark, Express Scripts and Optum Rx — in a hearing Tuesday over alleged anticompetitive practices and their companies’ role in increasing prescription drug costs. Read More
The FDA has finalized its guidance on the use of electronic health records (EHR) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. Read More