Sanofi Gets Priority Review for Investigational Enzyme Therapy

The FDA has granted a priority review to Sanofi’s biologics license application (BLA) for an experimental enzyme replacement therapy for patients suffering from Pompe disease, a rare illness that causes muscle deterioration and reduced lung capacity. Source: Drug Industry Daily

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Russia Denies Pause in COVID-19 Vaccine Trial

Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever paused. Source: Drug Industry Daily

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FDA Issues Advice on Cross Labeling for Oncology Drugs

The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a combination drug regimen. Source: Drug Industry Daily

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Meet Sooner With Us, Biosimilars Industry Asks FDA

Better communications between the FDA and sponsors, and more clarity from the agency on the issue of interchangeability, were among the suggestions from industry yesterday at a public meeting on the next iteration of the user fee program under the Biosimilar User Fee Act of 2017, dubbed BSUFA III. Source: Drug Industry Daily

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IMDRF Advances Device Conformity Assessment Documents

The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic. Source: The GMP Letter

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