A curve ball from the FDA for Repros Therapeutics Inc. played foul with the company's shares as investors learned that U.S. regulators have switched the firm's pre-new drug application meeting from a type B to a less-routine type C session in the first half of next month.
Nearly simultaneous approvals by the FDA of two oral drugs for idiopathic pulmonary fibrosis (IPF) set the market buzzing about the potential competitive and therapeutic advantages of each, as Roche AG prepared to launch its oral Esbriet (pirfenidone) and Boehringer Ingelheim GmbH (BI) lined up its oral kinase inhibitor, Ofev (nintedanib).
The industry has reached a tipping point with regard to women in higher-ranking positions, said Wende Hutton, general partner with venture capital (VC) firm Canaan Partners.
With $20 million in new series B cash, Dnatrix Inc. is using one of the mildest, albeit annoying, diseases – the common cold – to fight one of the more virulent and deadly illnesses – recurrent glioblastoma – by way of an oncolytic viral approach that just might succeed where a handful of others could not.
With a phase III trial bearing an identical endpoint and dosing schedule already under way, Alnylam Pharmaceuticals Inc. reported favorable data from the phase II open-label extension (OLE) study with patisiran, the RNAi therapy for transthyretin (TTR)-mediated amyloidosis (ATTR) in patients with familial amyloidotic polyneuropathy (FAP).
With a global, confirmatory phase III trial under way as of June with Translarna (ataluren) in nonsense mutation cystic fibrosis (nmCF), plus a phase III experiment in nonsense mutation Duchenne muscular dystrophy (nmDMD) fully enrolled as of last month, PTC Therapeutics Inc. is raising $108.75 million through the sale of 3 million shares at $36.25 each.
With encouraging data from a phase I trial in amyotrophic lateral sclerosis (ALS) and a phase II trial under way testing NSI-566, Neuralstem Inc. has begun – with the same candidate – the first human neural stem cell study to be given the FDA's nod for chronic spinal cord injury.
The stellar top-line data unveiled in January from Intercept Pharmaceuticals Inc.'s phase IIb obeticholic acid (OCA) trial known as FLINT in nonalcoholic steatohepatitis (NASH) helped the shares to a near 300 percent gain and whetted investor appetite for the full results, but it looks like they'll have to wait longer than next month's annual meeting of the American Academy for the Study of Liver Diseases (AASLD).
By now I’ve learned to keep my flu shot habit a secret. Every year about this time, since I was 18 years old, I get vaccinated. But long ago I stopped telling people about it, so I don’t have to hear: “Oh, you know the flu vaccines are made of antifreeze [mercury, aluminum, formaldehyde], right?” or “That’s a crazy thing to do, because the shot itself can make you sick!” or – this one’s fairly new – “You don’t really need it if you’ve got a healthy immune system. Anyway flu shots cause Alzheimer’s [in the old] and autism [in...
The modified intent to treat (mITT) phase III results with Alcobra Ltd.'s non-stimulant metadoxine extended release (MDX) for attention deficit hyperactivity disorder (ADHD) in adults gave investors the jitters, but they may have been distracted from the real meaning of top-line data by the exclusion of four high responders to placebo.
