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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
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
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
In its efforts to develop new guidances, the FDA is seeking information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCP) and the best way to advance development of new biosimilar biological products. Read More
The FDA offers recommendations on what’s needed to support chemistry, manufacturing and controls (CMC) changes for biosimilars and interchangeable biosimilar products, in a new draft guidance. Read More
This edition of Quick Notes focuses on FDA approval for Roche’s Vabysmo, reintroduction of Susvimo following a recall, EC approval of Dupixent and Samsung Bioepis’ Soliris biosimilar. Read More
The Department of Justice’s complaint against Regeneron that the company’s single cash-or-credit price is a violation of the False Claims Act “is not only incompatible with the text of the relevant statute and regulations, but divorced from reality,” the company says in a recent filing. Read More