Merck & Co. Inc. Chairman and CEO Kenneth Frazier’s resignation in August from a White House advisory council was an act of principle, and a reminder that 30 years ago Merck was one of the...
PTC Therapeutics Inc. (NASDAQ:PTCT) said FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet on Sept. 28 to discuss the company's NDA for Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (nmDMD)....
ViiV Healthcare Ltd. (Brentford, U.K.) said it submitted regulatory applications to FDA and EMA for a single-tablet combination of Tivicay dolutegravir and Edurant rilpivirine to treat HIV-1 infection. The company said the combo is the...
PTC Therapeutics Inc. (NASDAQ:PTCT) said it intends to launch Duchenne muscular dystrophy (DMD) drug Emflaza deflazacort "in the coming weeks" at an anticipated annual net price of $35,000 for a 25 kg patient. It forecast...
In an update to its eligibility criteria, PhRMA will now require companies to meet benchmarks in R&D spending to be members. Companies must spend at least 10% of global sales on R&D and spend at...
PTC Therapeutics Inc. (NASDAQ:PTCT) lost $1.46 (12%) to $10.79 on Monday after it revealed plans for its impending launch of Duchenne muscular dystrophy drug Emflaza deflazacort, including its price. As it reported 1Q17 earnings, the...
At the end of 2016, investors argued that equity values had nowhere to go but up. This proved to be the case in 1Q as all market cap bands finished in the black. Sector specialists,...
PTC will acquire Duchenne muscular dystrophy drug Emflaza deflazacort from Marathon. Marathon had proposed pricing the drug at a wholesale acquisition cost (WAC) of $89,000 per year, but suspended its launch plans after facing criticism....
Amid widespread criticism over the drug's proposed price, PTC Therapeutics Inc. (NASDAQ:PTCT) is acquiring Emflaza deflazacort from Marathon Pharmaceuticals LLC (Northbrook, Ill.) for $140 million, five weeks after FDA approved the steroid to treat Duchenne...
In a letter to FDA Acting Commissioner Stephen Ostroff, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) asked the agency to defend its approval of Emflaza deflazacort from Marathon Pharmaceuticals LLC (Northbrook, Ill.) and...