Armetheon Inc., of Menlo Park, Calif., said the EMA's Scientific Advice Working Group will allow the company to run a single, 1,000-patient pivotal study prior to filing a market authorization application for its experimental oral anticoagulant, tecarfarin. Read More
Viking Therapeutics Inc., of San Diego, said Poc Capital LLC agreed to pay up to $1.8 million in expenses associated with initial development of VK2809, including a planned proof-of-concept study, in patients with glycogen storage disease type Ia, or GSD Ia. Read More
Galena Biopharma Inc., of San Ramon, Calif., said it closed its underwritten public offering of 17 million common shares and warrants to purchase 17 million common shares priced at $1 per share and accompanying warrant. Read More
Incyte Corp., of Wilmington, Del., reported net product revenues for the quarter ending Dec. 31, 2016, of $238 million for Jakafi (ruxolitinib) compared to $182 million for the same period in 2015. Read More
NEW YORK – The Affordable Care Act (ACA) will be repealed, PDUFA VI will almost certainly be passed and the pressure on drug pricing will not go away in the coming year. While panelists during a panel on policy outlook under the new Trump administration largely agreed on those predictions, some noted that gaining a bit of certainty could be the biggest boon for the industry in 2017. Read More
Gilead Sciences Inc., pressured by declining sales in its hepatitis C franchise and slower than anticipated growth in its HIV line-up, is putting its best foot forward at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle this week. Read More
Adding to its portfolio in an increasingly attractive therapeutic area and hoping to bring back patients after a landmark Women's Health Initiative (WHI) study on estrogen treatments, Amag Pharmaceuticals Inc. signed a deal with Endoceutics Inc. that brings U.S. commercial rights to Intrarosa (prasterone), an FDA-cleared, daily non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA) due to menopause. Read More
Caught in an instant firestorm over the $89,000 list price for its new Duchenne muscular dystrophy (DMD) drug, Marathon Pharmaceuticals LLC is doing some unprecedented backtracking, as it pauses the commercialization of Emflaza in the U.S. to give it more time to discuss access to the drug with the DMD community. Read More
