Three weeks after an FDA panel overwhelmingly rejected Aveo's bid to gain an approval for its kidney cancer drug tivozanib, the biotech has earned another vote of no confidence--this time from its pharma partner.
Merck has cut one of most advanced efforts to develop a new therapy for Parkinson's disease. Its Phase III clinical trials of preladenant for the prevalent neurological disorder failed to beat placebo, prompting the U.S. drug giant ($MRK) to halt extension studies of the experimental A2A receptor agonist and abandon plans to file for regulatory approvals for the treatment.
Scientists failed to replicate the tantalizing evidence of efficacy from a study of the cancer drug bexarotene in mouse models of Alzheimer's disease, throwing cold water on efforts to advance the approved anti-tumor therapy for patients with the memory-stealing illness.
For years patients from depression have been cycled through one drug after the next, a hit-and-miss approach that also reflects the poor odds of success in clinical development. But now investigators say that a trial of a well-known anesthetic often used illicitly in the club scene has real potential in the fight against depression.
H.I.G. BioVentures has stepped up to lead a $34 million round for Seattle-based Cardeas Pharma, which is developing new antibiotics for drug-resistant bacterial infections.
For 5 long years the IPO window on Wall Street has largely been closed to biotech companies. But with investors warming up to the potential rewards after a lengthy chill, Portola Pharmaceuticals became the latest biotech to pull off a successful maiden offering. The biotech raised $122 million from the sale of 8.4 million shares, sticking to the middle of its range after pricing shares at $14.50.
Seaside Therapeutics has revealed its second failed study for its lead drug STX209 this month. In one of two Phase III studies for the compound for the genetic mental disorder Fragile X syndrome, STX209 treatment missed its main goal of reducing social withdrawal.
In a bid to join the billion-dollar sales club, the UK's BTG has snapped up a pair of operations with new delivery tech and a treatment for deep vein thrombosis for up to $420 million—most of that in cash. And it's selling a chunk of shares to help pay for it all.
Johnson & Johnson built its R&D rep around blockbuster development deals. Now the pharma giant's drug development arm wants the world to know that there's a comprehensive, global pipeline strategy in play that will deliver more than 10 new product applications over the next 4 years. And new drug development efforts in China and Japan are growing to rival the work it does in the U.S. and Europe.
A panel of experts assembled by the FDA has given Merck a boost in its quest for an approval of the sleep drug suvorexant.
The European Medicines Agency will provide an accelerated review of the treatment combined with ribavirin, which is shaping up as the first all-oral hepatitis C regimen up for a regulatory decision.
Two Swiss billionaires--Ernesto Bertarelli and Hansjorg Wyss--have joined forces to buy out the former Merck Serono facility in Geneva, with ambitious plans to create a major collaboration on discovery work and translational research while offering a home for a new generation of biotech companies in the region.
A group of ex-oil traders who created a new private equity group dubbed Hydra has decided to back the two lead programs at Seattle-based Kineta. There's no word on just how much they're investing in the biotech, but the "major investment" will be used to develop ShK-186, a Phase I immune-sparing autoimmune disease drug, and rOAS, a pan-viral therapeutic "aimed at an array of high priority contagious pathogens" now headed into the clinic.
In the first collaboration of its kind, the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority has brought on GlaxoSmithKline to help the federal agency develop new antibiotics to combat bioterrorism and growing resistance to the drugs.
According to an analysis by Bloomberg, Novartis is interested in finding a competitive Alzheimer's drug program. But it's hard to determine from the story if the pharma giant--always reluctant to detail partnering efforts or in-house strategies--has anything specific in mind.
Just a year or two ago, analysts and investors were in a frenzy over the frantic race to develop a new set of hepatitis C drugs that promised to change the standard of care. Now, as the leaders in that race approach the first round of likely marketing approvals, a new R&D competition has grabbed analysts' feverish attention as the next big thing in biopharma. And the leading players in this field may once again be betting on a mega-blockbuster payoff.
Grifols has agreed to foot up to $65 million of the Phase III bill, with a promise of $25 million in development milestones for a successful outcome. And Grifols is buying up a 35% stake in Aradigm at a cost of $26 million.
Turns out there was some truth behind the rumors that 3i was shopping the anti-infectives company Xellia.