San Diego biotech Lumena Pharmaceuticals has nailed down a $45 million B round with plans to move forward with treatments for two liver diseases, one a painful orphan condition and the other a fast-spreading cause célèbre in the biotech world.
It turns out that Bayer doesn't want to be in the chin-fat busting business after all. Bayer's consumer care arm handed back its ex-U.S. rights in Kythera Biopharmaceuticals' lead treatment ATX-101, aimed at eliminating the double chin. And in return Bayer gets a $33 million chunk of Kythera's stock, a $51 million note payable by 2024 and some potential longterm sales milestones.
La Jolla Pharmaceutical's chronic kidney disease drug hit its primary endpoint of improving organ function in a Phase II trial, the company said, and while the results sent the biotech's shares skyward by 75%, a quirk in dosing gave some analysts pause.
Sanofi is joining forces with UCB to study new small-molecule approaches to treating inflammatory conditions like arthritis, looking for an easier form of administration to some of the blockbuster injected biologics that dominate the field. The pharma giant is ready to spend more than $138 million for a package of milestones and an upfront payment to UCB in exchange for the partnering arrangement with its NewMedicines research arm.
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.
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.
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.
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.