32 documents

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01:31 , Sep 2, 2017 |  BioCentury  |  Strategy

Breach of contract

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...
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20:59 , Jun 6, 2017 |  BC Extra  |  Clinical News

FDA panel to review PTC's Translarna for DMD

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)....
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22:21 , Jun 2, 2017 |  BC Extra  |  Clinical News

ViiV submits Priority Review voucher with HIV combo

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...
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03:57 , May 12, 2017 |  BC Week In Review  |  Company News

PTC reveals price of steroid for DMD

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...
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22:44 , May 9, 2017 |  BC Extra  |  Politics & Policy

PhRMA revises eligibility criteria, cutting membership

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...
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22:56 , May 8, 2017 |  BC Extra  |  Company News

PTC reveals price of steroid for DMD

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 company...
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22:39 , Apr 7, 2017 |  BioCentury  |  Finance

Fade to black

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,...
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16:26 , Mar 17, 2017 |  BC Week In Review  |  Company News

Marathon, PTC deal

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....
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21:58 , Mar 16, 2017 |  BC Extra  |  Company News

Marathon offloads Emflaza to PTC

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...
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23:49 , Mar 15, 2017 |  BC Extra  |  Politics & Policy

Sanders, Cummings press FDA on Marathon's Emflaza

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...
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