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. Source: Drug…
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…
Jeff Shuren, currently Director of CDRH, has announced that he is leaving the agency after 28 years of service including 15 years as the director. Source: Drug Industry Daily
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…
Guardant Health has agreed to pay $900,000 to settle allegations that it participated in a scheme with a physician to submit charges to Medicare in violation of the False Claims…
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 —…
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.…
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…
Merck announced that its investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints. Source: Drug Industry Daily
Prescription benefit managers (PBM) use drug rebate payments to promote use of brand name drugs instead of generics, says a report released ahead of a House Committee on Oversight and…