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).
Otologic Pharmaceutics Inc.’s $4.1 million in series A funding will help the Oklahoma City-based firm start a phase I trial this year with NHPN-1010, an oral combo therapy designed to reverse noise-induced hearing loss.
The once-popular image of disease foundations as “old ladies in tennis shoes” busy mainly with direct patient care is going away, said Annette Bakker, president and chief scientific officer of the Children’s Tumor Foundation (CTF). And that’s good news.
With its once-yearly implanted-pump exenatide in phase III FREEDOM trials for type 2 diabetes, Intarcia Therapeutics Inc. became the highest-valued privately held biotech in the history of the industry by way of a $200 million financing that includes $57 million from the Foresite Capital Fund II, a growth equity stash designed to back firms “when we know things are working,” said managing director Christine Aylward.
With its protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab showing strong anti-cholesterol results across patient populations and dosing schedules (monthly as well as every two weeks) in phase III trials, Amgen Inc. held fast against data provided thus far by Regeneron Pharmaceuticals Inc. with alirocumab, also targeting PCSK9.
