In a deal with just $50 million up front but the potential to reach $2.5 billion, Tokyo’s Taiho Pharmaceutical Co. Ltd. and Astex Pharmaceuticals Inc., of Cambridge, U.K., are joining Merck & Co. Inc. in an exclusive worldwide research collaboration and license agreement to develop small-molecule inhibitors against several cancer targets, including the KRAS oncogene.
While Novan Inc.’s phase III failure in treating molluscum contagiosum for patients ages 6 months and older battered its stock Friday, the company intends to take the positive data it gleaned to the FDA to discuss an NDA submission and a possible phase III trial for next year.
Positive top-line data from two pivotal phase III studies of acne vulgaris treatment Twyneo from Sol-Gel Technologies Ltd. is doing the stock end-of the-year favors as shares closed up 19% at $17.50 on Tuesday.
Acceleron Pharma Inc. and Fulcrum Therapeutics Inc., two Cambridge, Mass.-based companies that have benefited from partnerships, agreed to an R&D collaboration and license agreement to identify small molecules for treating an undisclosed target in pulmonary disease.
The stock at Spring Bank Pharmaceuticals Inc. (NASDAQ:SBPH), after an especially rough Thursday, began healing a bit as investors took in the company’s decision to stop dosing and enrolling patients in its phase IIb Catalyst trials.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
In a move that Sarepta Therapeutics Inc.’s president and CEO, Doug Ingram, called “transformational” for the company and “the largest licensing transaction in cell or gene therapy history,” Sarepta granted Roche Holding AG exclusive commercial rights outside the U.S. for SRP-9001, its gene therapy for Duchenne muscular dystrophy (DMD).
While Ebola virus disease in the U.S. is a rare occurrence, the FDA approval of Merck & Co. Inc.’s Ervebo, the agency’s first for preventing Ebola Zaire virus in people age 18 and older, will have a ripple effect across the world, especially Africa where its effects have been devastating for decades. Stockpiling such a vaccine is crucial to world safety as Ebola has long been a potential bioterrorism threat, especially after 9/11. In the world of theoretical biological warfare, where the virus could be weaponized and disseminated by aerosol, Ebola virus is considered the most dangerous, with fatality rates estimated between 25% to 90%.
