Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.
Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.
Four bills aimed at lowering prescription drug prices were advanced out of the U.S. Senate Judiciary Committee this week and will head to a vote on the Senate floor.
National Cancer Control Efforts Should Address the System, Not Its Individual Parts, Says New Report
Current cancer control efforts in the United States typically are fragmented and uncoordinated, but taking a systems approach to establish a U.S. National Cancer Control Plan would address the challenge more holistically, says a new report from the National Academies of Sciences, Engineering, and Medicine.
Polarean Imaging plc, the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the visualisation of pulmonary function in the magnetic resonance imaging market, announces its audited final results for the year ended 31 December 2018.
Allergy Therapeutics plc, the fully integrated commercial biotechnology company specialising in allergy vaccines, announces that it has received a $7.6m settlement from Inflamax Research Inc. in relation to legal proceedings about the previously disclosed inconclusive Phase II Grass MATA MPL trial which took place in the USA in 2015-16.
Allergy Therapeutics plc, the fully integrated commercial biotechnology company specialising in allergy vaccines, announces a pre-close trading update for the 12 months ended 30 June 2019 and the successful outcome of the litigation related to the Grass MATA MPL Phase II trial.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.