Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
Germany's Merck KGaA is looking to sell its $1 billion consumer healthcare unit after a group-wide strategic review.
The European XFEL is now online. Built to be the world's largest facility to house the most powerful x-ray lasers that can be produced, the XFEL would contribute to a better understanding of molecular and chemical process by imaging particles.
Researchers from the University of Edinburgh and Heriot-Watt University in the UK have developed a medical camera that could see through the human body and track endoscopic tools used to evaluate internal conditions.
US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
A collaboration to develop next generation chimeric antigen receptor T cell therapy (CAR-T) (RELATED: Kite begins EU trial of CAR–T therapy) was announced by Takeda Pharmaceutical Company Limited (TSE: 4502) and Noile-Immune Biotech Inc..
The US Food and Drug Administration (FDA) has cleared Adherium for its new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
GNS Healthcare (GNS), a leading precision medicine company, today announced that it has raised an additional $6 million in equity from Amgen Ventures with participation from existing investor Alexandria Real Estate Equities. The funds will be used to further develop the company's REFS™ causal machine learning and simulation platform and solutions across drug discovery & development, value-based drug solutions, care management, and health system business optimization. With this investment, Amgen Ventures joins other leading biopharma companies Celgene and Zambon Pharmaceuticals, leading health plans Regence Blue Cross Blue Shield (Cambia Health Solutions), and Horizon Blue Cross of NJ and provider Heritage Provider Network, in addition to Mitsui, GHO Capital, and Fort Rock Capital as shareholders of GNS.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
Apollo Endosurgery has received CE-Mark for its ORBERA365 Managed Weight Loss System allowing commercialisation in the European Union (EU) and member countries of the European Economic Area.
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