In its fourth trip to the FDA, Endo's testosterone-boosting Aveed finally won over regulators, but as the clamor over risks tied to "low-T" treatments reaches deafening volume, the in-transition drugmaker may be late to a profitable party.
Peter Thiel's Founders Fund has rarely invested in biotech, looking for more consumer-related plays that help people navigate a turbulent landscape for healthcare.
One of the signal achievements for the biotech industry in the Affordable Care Act was a provision granting 12 years of market exclusivity to biologics. The decade-plus period of protection against generic competition ensured that biologics would remain center stage in the R&D world, especially as Big Pharma tumbled over the patent cliff as it tried to rethink its megablockbuster-sized budgets for drug development.
Texas biotech ZS Pharma banked a $55 million D round, cash that should help get its Phase III-tested treatment into the hands of regulators and, eventually, onto the market.
Now that it's steered its way successfully through the treacherous waters of a Phase II/III study for a new-and-improved drug for Parkinson's, Adamas Pharmaceuticals believes this is the right time to mount a $69 million IPO bid as it sets the stage for a pivotal trial.
Anyone looking to start a biotech company should pay close attention to this list. Venture groups, entrepreneurs and increasingly Big Pharma have been concentrating their money and their attention in a few key places, only occasionally straying from the beaten path when funding a high-risk drug development effort.
Gene editing pioneer Carl June at the University of Pennsylvania is back in the headlines. The academic investigator--heralded for his work on a gene editing technique now being tested for cancer--led a team of scientists who successfully used zinc finger nuclease (ZFN) technology from Sangamo to tailor their T cells, essentially locking a back door used by the lethal virus.
Novartis is making its way into late-stage studies for the orphan drug bimagrumab, and co-developer MorphoSys said sales of the muscle-growing treatment could peak at $4 billion a year.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.
Merck and its biotech partner are working to build a franchise of allergy immunotherapies, and their latest effort, an oral treatment for house dust mite reactions, improved symptoms in a mid-stage study.
Roche's lebrikizumab significantly reduced the rate of asthma attacks in patients with a severe form of the disease, according to mid-stage trial results, lighting the way for a Phase III study on the novel, personalized treatment.
The last 24 hours offered an important lesson over just how closely analysts and investors are tracking every movement on the immunotherapy front in cancer R&D.
The big biotech worked a deal with Eisai, offering to cover half of the research and development costs of a pair of mid-stage Alzheimer's therapies and adding an unspecified package of milestones and an upfront in exchange for half the potential profits.
After the markets closed on Tuesday, Xoma put out the word that its main pipeline asset, gevokizumab (Xoma 052) flunked a Phase II program for erosive osteoarthritis of the hand, ending any shot it had at a broad pivotal study in that indication.
Watch out, Google. Genome pioneer Craig Venter, well known for elbowing his way to the front of a scientific race, is launching a new company that will tackle the multitude of diseases that affect aging.
AbbVie's promising oral hepatitis C combo treatment is rolling along toward FDA approval, and the drugmaker unveiled a deeper set of Phase III data in which the cocktail cured nearly 100% of patients in a tough-to-treat population.
Theravance, the biotech engine behind GlaxoSmithKline's bright future in COPD, is gearing up to split in two next quarter, with one publicly traded company handling its revenue-generating drugs and the other leading the charge on R&D.
Shares of Oxygen Biotherapeutics shot up 30% Tuesday morning after the Morrisville, NC-based biotech announced that the FDA had lifted a clinical hold on Oxycyte, an experimental drug the military has been supporting as a possible treatment for traumatic brain injury.
With his nearly 20-year stint at Roche coming to an end, longtime Roche Chairman Franz Humer said he's leaving the drugmaker just as it gets out from under Genentech-related debt, clearing the way for some dealmaking and an R&D jump-start.
With IPOs still booming, follow-on financings sizzling and venture capital rolling in at a steady pace, the biotech industry has been stocking up on billions of dollars in cash.