The Internal Revenue Service (IRS) has issued temporary regulations for imposing billions of dollars of branded prescription drug fees on drugmakers under the Patient Protection and Affordable Care Act, but it was not immediately clear whether the complex rules resolved earlier industry concerns that included the data and process used to calculate fees for individual companies.
Amylin Pharmaceuticals Inc. and partner Takeda Pharmaceutical Co. Ltd. have discontinued development of combination obesity candidate pramlintide/metreleptin after what they described as a "commercial reassessment" of a revised development plan and the "evolving dynamics" of obesity therapeutics.
Rare Disease Therapeutics Inc., a Franklin, Tenn.-based company focused on developing orphan products, has won FDA approval for Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the U.S.
AMAG Pharmaceuticals, Inc. shares (NASDAQ:AMAG) gained $1.61, or 11.2 percent, to close at $16 Wednesday following an unsolicited offer from New York-based hedge fund MSMB Capital Management to buy the Lexington, Mass.-based company's outstanding stock for $18 a share in cash, a 25 percent premium above the previous closing price, in a deal worth about $378 million.
Active Biotech AB stock plunged 53.5 percent and partner Teva Pharmaceutical Industries Ltd.'s shares took a 6.2 percent hit Monday following their announcement that oral multiple sclerosis (MS) drug laquinimod did not achieve its primary endpoint of reducing the annualized relapse rate (ARR) in the Phase III Bravo trial.
For those to whom much is given, much is expected. So it is with Vertex Pharmaceutical Inc. as several analysts upped their sales estimates for just-launched hepatitis C treatment Incivek (telaprevir) after the company reported second quarter sales of about $75 million – more than doubling previous Street estimates and more than tripling second quarter sales of $21 million for Merck & Co. Inc.'s competing Victrelis (boceprevir).
San Diego-based Vical Inc. signed a potential $130 million-plus license agreement with Astellas Pharma Inc., of Tokyo, for worldwide development and commercialization of Vical's TransVax vaccine for cytomegalovirus (CMV) reactivation in hematopoietic stem cell transplant and solid organ transplant recipients.
Jinzi Wu, CEO of biotech start-up Ascletis Inc., has flown so often between the company's China headquarters in Hangzhou and U.S. facility in Research Triangle Park, N.C., that he said he's not a "sea turtle" – the phrase for returning Chinese scientists – but rather a "sea gull."
WASHINGTON – Getting funding for candidates beyond the lead compound continues to be a challenge for platform companies with multiple programs. Where's the money coming from today – venture capital, partners, government grants, sovereign funding or foundation support?
