00:50 , Jan 15, 2019 |  BC Extra  |  Politics & Policy

MSKCC says senior execs may not hold industry board seats

Memorial Sloan Kettering Cancer Center has barred its senior executive officers from holding board positions at MSKCC spinouts or external for-profit health and science-related entities, according to a staff memo sent by SVP and Chief...
19:41 , Jan 9, 2019 |  BC Extra  |  Company News

Senior FDA official to head government affairs at CRISPR Therapeutics

John Martin, principal associate commissioner for legislative affairs at FDA, is leaving the agency and joining CRISPR Therapeutics AG (NASDAQ:CRSP) as head of government affairs. Martin, who joined FDA in 2017, led the agency's negotiation...
21:18 , Oct 22, 2018 |  BC Extra  |  Politics & Policy

FDA advisory committee to consider CV studies for diabetes drugs

FDA will ask an advisory committee this week to consider whether cardiovascular outcomes trial requirements for diabetes drugs should be diminished or discarded, according to draft questions released ahead of the Oct. 24-25 meeting. Intensified...
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...
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....