Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year.
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.
Shares of Entera Bio Ltd. (NASDAQ:ENTX), a lightly traded Israeli drug delivery specialist, fell 27% on May 21 after the company said an ongoing phase II trial of its oral parathyroid hormone (PTH) candidate in osteoporosis patients found the two lowest doses tested demonstrated "suboptimal increases" in P1NP, an important biomarker of bone formation.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
Fountain Therapeutics Inc., a California company working to create treatments for age-related diseases, said Khosla Ventures has led a $6 million series A-1 financing of the startup, with participation from Nan Fung Life Sciences, which earlier contributed $5 million to the round.
A global HIV prevention study comparing a long-acting injectable antiretroviral from Viiv Healthcare Ltd. to a daily pill from Gilead Sciences Inc. has stopped early after Viiv's cabotegravir proved 69% more effective than the current standard of care, Gilead's Truvada (emtricitabine/tenofovir), in preventing HIV acquisition (95% CI 41%-84%).
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.
A new phase IIb readout at odds with earlier data suggesting PTI-125 would diminish key biomarkers of neuroinflammation and neurodegeneration in Alzheimer’s patients has left Cassava Biosciences Inc. President and CEO Remi Barbier looking for answers.
Shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) leapt 36% higher to $42.12 on Thursday after limited data from a small number of relapsed/refractory (r/r) non-Hodgkin lymphoma patients showed a combination of the company's anti-CD19 allogeneic CAR T candidate, ALLO-501, and an anti-CD52 monoclonal antibody, ALLO-647, met with an overall response rate of 78%.
Despite evidence of efficacy in binge-eating disorder (BED), Sunovion Pharmaceuticals Inc.'s dasotraline's second lease on life is done, for now. Following an initial plan to discontinue the asset in a 2010 portfolio reshuffle, the drug is now being shelved due to the need for additional clinical studies on its benefit-risk profile, parent Sumitomo Dainippon Pharma Co. Ltd. said.
