Oklahoma joined growing litigation over claims drugmakers misrepresented the risks of opioid painkillers, as New Hampshire cleared a hurdle in its own probe of the role played by companies in the national addiction epidemic.
FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).
BioMarin Submits Pegvaliase Biologics License Application to the U.S. FDA for Treatment of Phenylketonuria
BioMarin Pharmaceutical Inc. announced that the company submitted a Biologics License Application on June 30, 2017 to the U.S. Food and Drug Administration for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.
Roche bought Vienna-based diabetes management platform mySugr, joining a crowd of companies expanding app-based digital health services.
The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
Dublin, Ireland-based Shire plans to consolidate more than 3,000 staffers spread out at over half-a-dozen locations across Massachusetts to two campuses in Cambridge and Lexington.
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Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.
Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)
Acorda Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for Inbrija (CVT-301, levodopa inhalation powder). Acorda is developing Inbrija as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, Inbrija, has been conditionally accepted by the FDA.
First Scientifically Validated Symptom Checker with Artificial Intelligence Launches in the United States
Mediktor, a European health technology company, announced the U.S. launch of the first scientifically validated health checker based on artificial intelligence.