Applied Genetic Technologies Corp. (AGTC) dropped two pieces of bad news following Wednesday's market close. The Gainesville, Fla.-based company said it was halting development of rAAV2tYF-CB-hRS1, its adeno-associated virus (AAV)-based RS1 gene therapy for X-linked retinoschisis (XLRS), after top-line interim data from its phase I/II trial showed no sign of clinical activity at six months. AGTC also revealed that Biogen Inc. was walking away from their three-year-old, potential $1 billion collaboration and returning full rights to the clinical-stage XLRS and X-linked retinitis pigmentosa (XLRP) programs and discovery programs in adrenoleukodystrophy (ALD) and two ophthalmic targets, effective March 8, 2019. Read More
Sponsors of generics likely heaved a big sigh of relief Thursday when the FDA said it was tossing a controversial proposed rule that would have put generics on the hook for state failure-to-warn claims. Read More
Taking advantage of what Amag Pharmaceuticals Inc. President and CEO Bill Heiden called a "significant growth opportunity," the company is acquiring anticoagulant reversal agent developer Perosphere Pharmaceuticals Inc. for $50 million up front and up to $365 million in potential milestone payments. Analysts lauded the intent of the deal, praising its potential to further diversify Amag's portfolio and complement its oral iron therapy, Feraheme (ferumoxytol). But differentiating the phase II candidate, ciraparantag, from already-approved reversal agents Praxbind (idarucizumab) and Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), will be key to the program's success, they said. Read More
LONDON – Don't mention the B word: On a day when anxiety levels over Brexit ratcheted further upward, the if, how and when of the U.K.'s leaving the EU suffused the atmosphere at the 18th annual Genesis conference in London on Thursday. Read More
A scrappy joint meeting of the House Subcommittee on Healthcare, Benefits, and Administrative Rules and the House Subcommittee on Government Operations featured opposing views of current science with regard to fetal tissue research in a two-hour-plus session that included Chairman Rep. Mark Meadows (R.-N. Carolina) objecting to the sale of "baby parts." Read More
WASHINGTON – U.S. FDA commissioner Scott Gottlieb had some pointed words for drugmakers regarding data integrity at a Food and Drug Law Institute (FDLI) meeting in the nation's capital, while Bill Maisel, the acting director of the agency's device center, had better news for device makers on regulatory harmonization efforts. Read More
The U.S. Patent and Trademark Appeal Board (PTAB) found all the claims in two formulation patents for Sanofi SA's Lantus (insulin glargine) unpatentable as the result of an inter partes review (IPR) requested by Mylan NV, of Hertfordshire, U.K. Read More
Kuros Biosciences Ltd., of Schlieren, Switzerland, disclosed total gross proceeds of CHF16.1 million (US$16.2 million) in its rights offering and placement of 6.5 million new registered shares priced at CHF2.50 apiece. Read More
VLP Therapeutics LLC, of Gaithersburg, Md., said the Global Health Innovative Technology Fund awarded the firm a $3.9 million grant to further develop a tetravalent dengue virus-like particle vaccine. Funding will enable further development and manufacturing. Read More
