In stealth mode until about six months ago, Nora Therapeutics Inc. raised $18 million in series B cash to expand the development of NT100 into a second phase II trial in women with unexplained recurrent loss of pregnancy.
Epirus Pharmaceuticals Inc.'s all-stock takeover of Zalicus Inc., disclosed on the same day that Epirus put the wraps on a $36 million series B round, will add early stage pain drug candidates to its pipeline of biosimilars and immediately put some joy back into Zalicus' shares (NASDAQ:ZLCS), which closed Wednesday at $1.35, up 32 cents, or 31 percent.
About 13 years ago, when Amber Salzman's son and two nephews were diagnosed with adrenoleukodystrophy (ALD), a genetic brain disorder, she didn't know much about rare diseases at all. That's changed for the CEO of Paris-based AAVLife, which – with $12 million in series A money – is taking aim at another: Friedreich's ataxia (FA).
Lexicon Pharmaceuticals Inc.'s phase II data with oral LX4211 in type 1 diabetes could be just enough to "transport" the company into the sweet deal that investors have been waiting for.
Regado Biosciences Inc. aims to fuel with $60 million in fresh funding the phase III trial begun last year, testing the anticoagulant REG1 in patients undergoing percutaneous coronary intervention (PCI). Called Regulate PCI, the study is comparing REG1 to Angiomax (bivalirudin, The Medicines Co.) with a primary endpoint based on a composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent target lesion revascularization through day three following the procedure.
Merck & Co. Inc. nearly stole the show at the European Association for the Study of the Liver (EASL) meeting in London with results from an ongoing phase II trial testing its all-oral combo drug for hepatitis C virus (HCV), but other firms kept the program lively, as Gilead Sciences Inc. held onto rock-star status. Mostly.
"It's not the usual model," explained Mark Gurney, CEO of Tetra Discovery Partners LLC, which is collaborating with the Broad Institute's Stanley Center for Psychiatric Research on drugs that might help cognitive impairment in schizophrenia.
Despite years of biotech and pharma sporadically deploying the adjust-as-you-go approach for good clinical purposes, the phrase "adaptive trial design" still puts the fantods into company backers.
Mallinckrodt plc’s second major buy in two months – about $5.6 billion for Questcor Pharmaceuticals Inc. – created more noise than the February takeover of Cadence Pharmaceuticals Inc. for about $1.3 billion, and not just because of the larger price tag.
Investors must wait until summer for the details about a pair of serious adverse events (SAEs) that caused Intercept Pharmaceuticals Inc.’s shares to lose altitude after skyrocketing on phase IIb data with obeticholic acid (OCA) in nonalcoholic steatohepatitis (NASH).
