The FDA has stamped its approval on sofosbuvir for hepatitis C, perhaps one of the most anticipated new drugs of the year. Gilead's therapy, which will be marketed as Sovaldi, will open the door to a new generation of treatments that don't require interferon--freeing patients from an arduous regimen tied to a host of nasty side effects.
Just over a month after crossing the T's on a $535 million acquisition by Cubist Pharmaceuticals, Optimer Pharmaceuticals is shedding 177 jobs in the U.S. and Canada, New Jersey's Star-Ledger reports.
Ariad Pharmaceuticals seemed to dodge a bullet last month when the European Medicines Agency chose not to follow its U.S. counterpart, letting the troubled Iclusig stay on the market. Now, the regulator is reopening the books on Ariad's cancer drug, reviving concerns about the company's sole product and sending its shares down about 10%.
Geron got an early gift from its friends at the Mayo Clinic, as a release of upbeat imetelstat results sent its shares skyward Friday morning, rising as much as 30% in premarket trading on news its myelofibrosis drug triggered complete remission in some patients.
Novartis' in-development multiple myeloma candidate LBH589 hit its primary endpoint of staving off cancer progression in a late-stage study, the company said, stoking hopes the Swiss drugmaker can take first place among a new class of treatments.
One of the first deals Flemming Ornskov struck as the new CEO of Shire has soured quickly. The company says that its therapy for dry eye, lifitegrast, missed one of two key endpoints in a Phase III study, raising some serious questions about its future.
Well-traveled biotech luminary Michael Foley has agreed to head up a new translational research effort that unites minds at Weill Cornell Medical College, the Rockefeller University and Memorial Sloan-Kettering Cancer Center with the mission of turning exciting lab work into promising drug candidates.
With pressure growing on Big Pharmas to be more transparent with their drug data, Pfizer says it plans to start unlocking the data vaults, with special plans to allow easy access for patients in studies to check out their personal info.
FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.
It's looking like the end of the line for Transcept Pharmaceuticals: The troubled biotech, long in search of a buyout offer, will be forced to liquidate if it doesn't find a benefactor before the second quarter of next year, the company said.
Eli Lilly extended its streak of Phase III flops today, reporting that its depression drug edivoxetine (LY2216684) failed to beat out a placebo in a slate of three Phase III studies. And the pharma company said it will add the drug to its growing scrap heap.
The brouhaha that erupted on Twitter when Puma Biotechnology switched to a Bayesian statistical model in its I-SPY 2 study to predict the likelihood of late-stage success of neratinib for metastatic HER2-positive breast cancer indicates that this approach could make the industry pause before the Bayesian predictive formula is widely adopted in the biotech world.
California's PaxVax has picked up $22 million in venture cash to get an oral cholera vaccine into the FDA's hands, working its way through late-stage trials for the single-dose treatment.
Menlo Park, CA's 5AM Ventures has pieced together a fourth fund, roping in $250 million with its eye on a new generation of promising drug developers.
Today, Cambridge, MA-based Zafgen said that it is banking $45 million from a Series E round, adding a group of new investors that includes RA Capital Management, Brookside Capital, Venrock, Alta Partners, an undisclosed blue chip investor and a private investor.
A little more than two months after GlaxoSmithKline abandoned its $1.5 billion partnership on ChemoCentryx's lead drug, the Crohn's drug vercirnon, scrapping three late-stage studies after the first Phase III flopped, the biotech says that GSK has begged off pursuing a follow-up anti-inflammatory program and returned another drug--CCX354--licensed out four years ago.
The Medicines Company is taking a deep dive into hospital-borne infection treatments, signing a deal worth up to $464 million to pick up Rempex Pharmaceuticals and its fleet of pathogen-fighting drugs.
Once-rival researchers from the Fred Hutchinson Cancer Research Center and Memorial Sloan-Kettering Cancer Center have decided to join forces and dive into drug development, hauling in a massive $120 million Series A round to advance "smart" T cells that spur an immunologic attack on cancers.
Three big players in the life sciences industry--Celgene, Eli Lilly and GE Ventures--are chipping in to help fund a $100 million venture fund that will be used to launch up to 20 new biotech companies in New York City, adding some fuel to a small but growing fire of R&D efforts in the Big Apple.