Pharmaceuticals, Biotechnology and Life Sciences
FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Puma Biotechnology’s PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.
Harpoon Therapeutics, a new Arix Group Business, has closed a Series B investment round raising $45 million.
The U.S. Food and Drug Administration (FDA) has approved Roche’s Actemra/RoActemra (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition.
The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10 to 3 that the overall Benefit-Risk profile of Emmaus Life Sciences’s Endari for the treatment of sickle cell disease (SCD) is favorable.
Bioverativ has acquired South San Francisco-based True North Therapeutics, a privately-held, clinical-stage rare disease biotechnology company, for an upfront payment of $400 million plus assumed cash.
Emmy and Tony award-winning actress and singer, Kristin Chenoweth will kick off Allergan’s “Less Red, More You” campaign at an exclusive event in New York City.
Boehringer Ingelheim has reported new analyses that provide further evidence that adding SPIRIVA RESPIMAT improved breathing across diverse patient populations who experience uncontrolled asthma symptoms despite the use of another daily maintenance therapy in the Phase III clinical development program.
Alexion Pharmaceuticals has announced big changes to its executive leadership team. Brian Goff is joining Alexion as Chief Commercial Officer, effective June 1, 2017.
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).
Novo Nordisk has submitted a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.