Some of the leaders in the frenzied late-stage race to develop a PCSK9 drug watched their stock prices stumble on Friday afternoon as word of the FDA's concern about potential neurocognitive side effects in the cholesterol drug class ripped through Twitter.
Fresh off positive results for its late-stage lung drug, InterMune has attracted some M&A interest from a flock of pharmaceutical companies, according to Reuters, sending the biotech's shares up roughly 12% on Friday.
In contrast to NewLink Genetics, Northwest Biotherapeutics' interim analysis was a boon to the company's investors, as word that its Phase III trial of a personalized cancer vaccine was going according to plan sent its shares up as much as 10%.
In the midst of rethinking its approach to R&D, AstraZeneca has dabbled in the virtual model of drug development, matching a small in-house staff with collaborators on contractors around the globe to make the process more efficient. Now, after some early success in neuroscience, the pharma giant is amping up its virtual efforts in oncology, signing a deal with a South Korean institution to hunt for new targets in the field.
Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.
Recro Pharma had to dial down its asking price and amp up its offering, but the Malvern, PA, biotech managed to go public at last, grossing $30 million to fund its pipeline of pain treatments.
After an interim analysis, NewLink Genetics is planning to keep on keeping on with a Phase III study of its cancer vaccine. But that news came as an apparent disappointment to investors, who hoped the drug's promise would result in an early trial termination, and the biotech's shares fell more than 12% on Friday morning.
Incyte CEO Hervé Hoppenot has been telling anyone who'll listen that his biotech is undervalued and underestimated, and now, with promising late-stage results for its lead drug in a rare blood cancer, the company has a shot at blockbuster sales alongside partner Novartis.
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.