Immunogen Inc. said the FDA wants yet another phase III, randomized trial for mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer, so the company is prepping a redesigned study for a launch later this year.
Myovant Sciences Ltd. was thrilled with Tuesday's data announcement from the first of two phase III studies of relugolix, in which Liberty 1 met its primary efficacy endpoint and six secondary endpoints in women with uterine fibroids. The results keep the phase III races tight between relugolix, Abbvie Inc.'s elagolix and Obseva SA's OBE-2109.
Results from Minerva Neurosciences Inc.'s phase IIb study of seltorexant (MIN-202) announced on Monday bode well for further studies of the drug but couldn't bump the company stock out of the doldrums.
Chimerix Inc. is discontinuing clinical trials for oral and intravenous brincidofovir because it can't attract enough patients for the studies, the company said Thursday. The shutdown means laying off more than half its staff in Durham, N.C.
Adimab LLC announced three deals in a single day Wednesday by disclosing it will transfer its platform to Takeda Pharmaceuticals Co. Ltd., expand on an earlier multitarget research agreement with Regeneron Pharmaceuticals Inc. and up the ante on an agreement with Novartis AG to optimize antibodies against nine targets.
Cancer Prevention Pharmaceuticals Inc. (CPP) and its partner, Mallinckrodt plc, said Tuesday the phase III trial of CPP-1X/sulindac in patients with the orphan disease familial adenomatous polyposis (FAP) did not meet its primary endpoint. Mallinckrodt doesn't plan to pursue the program's commercialization.
H. Lundbeck A/S, of Copenhagen, has acquired Abide Therapeutics Inc. in a deal designed to strengthen the Danish company's weakened pipeline and establish a research hub in the U.S.
Gilead Sciences Inc. missed its top-line numbers for the first quarter of the year but was bolstered by strong volume growth of its HIV franchise in the U.S. Its weakness came from lower sales for hepatitis C virus (HCV) drugs, down 21% from last year.
The FDA has approved Sanofi Pasteur Ltd.'s Dengvaxia vaccine to prevent dengue disease for children ages 9 through 16 with a previous dengue infection and who live in endemic areas of the U.S., including the territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
Vertex Pharmaceutical Inc. stood tall Tuesday as it announced first-quarter numbers that vaulted the company from a strong 2018 to an even more powerful new year as the top-line grew and the pipeline firmed up.
