22:15 , Oct 3, 2018 |  BC Extra  |  Company News

MSKCC President & CEO resigns from Merck's board

President and CEO of Memorial Sloan Kettering Cancer Center Craig Thompson will immediately resign from the boards of Merck & Co. Inc. (NYSE:MRK) and Charles River Laboratories International Inc. (NYSE:CRL) following revelations of financial ties...
02:01 , Sep 29, 2018 |  BioCentury  |  Politics, Policy & Law

PROs in prime time

A recommendation by CMS’s MEDCAC catapults the collection of PRO data to the postmarket setting from their more familiar spot in clinical development. CAR T leaders Novartis AG and Gilead Sciences Inc., however, are not...
23:43 , Sep 11, 2018 |  BC Extra  |  Politics & Policy

Former FDA chief counsel Wood rejoins Sidley

Former FDA Chief Counsel Rebecca Wood will rejoin Sidley Austin LLP as partner, a role she held in 2006-17. Wood worked at FDA for over a year before stepping down in July. She will co-lead...
20:17 , Sep 7, 2018 |  BioCentury  |  Strategy

Thinking beyond Bi

Following the resignation of Jingquan Bi, early signs for continued biopharma regulatory reform in China remain positive. But the IP reforms spearheaded by Bi look to have fallen off the government’s priority list, and there...
17:57 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Teva wins first FDA approval for generic EpiPen

FDA approved an ANDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) for the first generic version of EpiPen epinephrine auto-injector for the emergency treatment of allergic reactions including anaphylaxis. Mylan N.V. (NASDAQ:MYL) markets the...
22:52 , Aug 29, 2018 |  BC Extra  |  Politics & Policy

Part D to allow indication-driven formularies

Starting in 2020, CMS will allow Part D plans to include drugs on their formularies on an indication-by-indication basis, according to a memo released Wednesday. The change would allow plans to only cover certain indications of...
22:13 , Aug 22, 2018 |  BC Extra  |  Politics & Policy

After MEDCAC vote, CMS CAR T coverage could come down to PROs

CMS's Medicare Evidence Development & Advisory Committee voted that there is sufficient evidence to support the use of four different patient-reported outcome tools that could be used in future studies of CAR T cell therapies....
21:03 , Aug 13, 2018 |  BC Extra  |  Company News

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become director of global regulatory policy and R&D at Amgen Inc. (NASDAQ:AMGN). Khushboo Sharma becomes OND’s...
17:25 , Jun 2, 2018 |  BioCentury  |  Politics, Policy & Law

Getting flatter

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, brought the center’s entire staff of about 5,000 people together in the agency’s Great Room on June 1 for a town hall meeting to...
23:46 , May 16, 2018 |  BC Extra  |  Politics & Policy

CMS initiates national coverage analysis of CAR T therapies

CMS began a national coverage analysis Wednesday to review the use of CAR T cell therapies to treat cancer. An NCA is the first step in the path to developing a National Coverage Decision that would...