Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.
Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
Amarin Corp. plc's sale of $400 million in American depositary shares (ADSs) ahead of the Sept. 28 PDUFA date for Vascepa (icosapent ethyl) boosted investor confidence while sparking buzz about another player in the space: Acasti Pharma Inc., of Laval, Quebec, which has a krill oil-based product due to report pivotal data soon.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
Seongnam, Korea-based Bridge Biotherapeutics Inc. nailed down a deal with Boehringer Ingelheim GmbH (BI) to develop the former's phase I autotaxin (ATX) inhibitor, BBT-877, for fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF).
Kalvista Pharmaceuticals Inc. made big news in October 2017 by way of its handsome deal with Merck & Co. Inc. to advance KVD-001, an intravitreal injection candidate to treat diabetic macular edema (DME).
Just over a month after adding an indication to the label for Zerbaxa (ceftolozane/tazobactam), Merck & Co. Inc. gained FDA clearance of Recarbrio (imipenem, cilastatin and relebactam) 1.25 g for injection. The new combo antibacterial is indicated for adults who have limited or no alternatives for the treatment of complicated urinary tract infections (cUTI).
Trefoil Therapeutics Inc.'s $28 million from an oversubscribed series A financing will let the company finish a phase IIa proof-of-concept study as researchers edge toward attacking corneal endothelial dystrophy, including Fuchs dystrophy, a disease that leads to the deterioration of the endothelial layer on the back surface of the cornea.
"We tried to land on Mars and we got to the moon," Novavax Inc. President of R&D Gregory Glenn told BioWorld, referring to the Gaithersburg, Md.-based firm's phase III trial with the respiratory syncytial virus (RSV) vaccine called Resvax. And it was more than anyone had done thus far, he added.
