October 25, 2019 - Fierce Pharma
After an agonizing wait, Roche might finally be looking at an antitrust clearance from U.S. authorities for its proposed $4.3 billion takeover of Spark Therapeutics.
The Federal Trade Commission staff on the Roche-Spark case has
approval of the deal without any product divestiture requests, according to a report by the Capitol Forum cited by Reuters.
Roche had its eye on Spark’s gene therapy platform, especially its hemophilia franchise, when making the acquisition offer, officially
in late February—and that’s exactly what the FTC staff had been focused on, the report said.
October 23, 2019 - Fierce Biotech
Novartis has put up an initial
to land the global license to Pliant Therapeutics’ preclinical nonalcoholic steatohepatitis (NASH) asset and three additional candidates. The NASH drug, PLN-1474, is a small molecule inhibitor of integrin α
Pliant thinks can reduce the growth of fibrotic tissue in the liver.
“NASH is a difficult disease to tackle, and most compounds currently in development are targeting metabolic targets that address earlier stages of disease. PLN-1474 utilizes a fundamentally different mechanism from liver metabolism targeting drugs,” Pliant CEO Bernard Coulie said.
October 22, 2019 - BioPharma Dive
Biogen is filing its closely watched Alzheimer's disease drug aducanumab for approval in a major pivot from earlier this year, when the biotech halted two large studies of the drug because interim analyses signaled they were unlikely to succeed.
Biogen said it has consulted with the Food and Drug Administration about the new analysis and intends to submit a Biologics License Application for aducanumab in early 2020. If approved, it would be the first ever disease-modifying Alzheimer's drug to come to market, although it's not at all certain the FDA will agree with Biogen's new analysis.
October 22, 2019 - Fierce Biotech
As John Puisis was building a biotech company based on immune tolerance research from Northwestern University, venture capitalists asked him, “Why not just be a celiac disease company, a Type 1 diabetes company or a multiple sclerosis company?”
Now, with positive phase 2 data and a licensing deal with Takeda worth up to
, Chicago-based Cour has a partner to help get its celiac disease treatment to patients. Celiac is a genetically linked disease in which eating gluten, the protein found in certain grains, leads the immune system to damage the gut. Symptoms may vary, and there there is only one treatment: a gluten-free diet. Problem is, these diets can be hard to stick to, and, for some people, they don’t work.
October 22, 2019 - Outsourcing Pharma
Sartorius is set to acquire three biopharma businesses from Danaher, once the latter company concludes its deal for GE Biopharma.