Exelixis Inc. will waste no time making Cabometyx (cabozantinib) available to advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy, following the FDA's widely anticipated approval Monday.
Having worked in academia, big pharma and venture capital, Naia Ltd. co-founder H. Daniel Perez got to witness drug development from three different perspectives, and he came away with one conclusion: “It was very clear things were not being done efficiently,” he said.
Having worked in academia, big pharma and venture capital, Naia Ltd. co-founder H. Daniel Perez got to witness drug development from three different perspectives, and he came away with one conclusion: "It was very clear things were not being done efficiently," he said.
Nohla Therapeutics Inc., a 2015 spin-off of the Fred Hutchinson Cancer Research Center, has a simply stated yet ambitious goal, according to CEO Ben Bergo: to create a “truly universal, off-the-shelf” ex vivo-expanded umbilical cord blood stem cell product that can be administered to patients on demand without the need for human leukocyte antigen (HLA) matching.
Following a positive readout last month for a phase III trial in Dravet syndrome, GW Pharmaceuticals plc is keeping the momentum going, launching late-stage testing of Epidiolex in another rare epilepsy indication and looking ahead to what could be an exciting 2016 for the London-based firm as cannabinoid-based platforms appear finally to be catching on.
Executives of Clovis Oncology Inc. look to have an uphill battle convincing members of the Oncology Drugs Advisory Committee (ODAC) Tuesday of the clinical benefit of rociletinib in a subset of NSCLC patients, based on briefing docs released Friday raising questions as to both the drug’s safety and efficacy.
AB Science SA's shotgun approach to drug development appears to have scored another late-stage win. Just months after reporting positive phase III data with tyrosine kinase inhibitor masitinib in mastocytosis, the Paris-based firm disclosed interim results from a phase III study in which the drug met the primary objective in amyotrophic lateral sclerosis (ALS), a condition that has been littered with failure in the past two decades.
When Vitae Pharmaceuticals Inc. called a halt to enrollment in its phase IIa trial testing VTP-43742 in psoriasis with no explanation, investors naturally feared the worst, sending shares plummeting to a 52-week low earlier this month.
Regeneron Pharmaceuticals Inc. and partner Sanofi SA are hoping now to make their case in the Federal Circuit after a U.S. District Court jury ruled that patents covering Amgen Inc.'s competing PCSK9 antibody, Repatha (evolocumab), are valid, a decision that, if it stands, could put Regeneron and Sanofi on the hook for damages, including royalties from sales of Praluent (alirocumab).
Gensight Biologics SA launched a pair of phase III studies aimed at testing gene therapy candidate GS010's ability to preserve and restore vision in patients with blindness-causing Leber's hereditary optic neuropathy (LHON), a disease in which "time is of the essence," said Chairman and CEO Bernard Gilly.
