Policy

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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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FDA
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.
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).
FDA
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
During the first presidential debate of Democratic candidates vying for that party’s presidential nomination, it didn’t take long for the pharma industry to take center stage.
BioTek’s Synergy™ Neo2 Hybrid Multi-Mode Microplate Reader received expanded certification from Cisbio Bioassays for their proprietary HTRF® technology, a TR-FRET assay platform used in the Life Sciences.