19:52 , Jan 17, 2019 |  BioCentury  |  Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
18:17 , Jan 11, 2019 |  BC Week In Review  |  Company News

Regeneron, Sanofi narrow focus of immuno-oncology deal

By narrowing the focus of a 2015 immuno-oncology deal, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gains more freedom to play in its combinations sandbox as partner Sanofi (Euronext:SAN; NASDAQ:SNY) turns to other immuno-oncology agents in its pipeline....
00:11 , Jan 8, 2019 |  BC Extra  |  Company News

Regeneron, Sanofi narrow focus of immuno-oncology deal

By narrowing the focus of a 2015 immuno-oncology deal, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gains more freedom to play in its combinations sandbox as partner Sanofi (Euronext:SAN; NASDAQ:SNY) turns to other immuno-oncology agents in its pipeline....
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
00:02 , Dec 22, 2018 |  BC Extra  |  Company News

Management tracks: United Neuroscience, Zymergen

Neurodegenerative diseases company United Neuroscience Ltd. (Dublin, Ireland) hired Peter Powchik as its first EVP of R&D, effective Jan. 1. He was SVP of clinical development at Regeneron Pharmaceuticals Inc. (NASDAQ:REGN). Zymergen Inc. (Emeryville, Calif.)...
02:33 , Dec 8, 2018 |  BioCentury  |  Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
18:31 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

Regeneron planning Phase II for REGN1979 in lymphoma following ASH readout

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) plans to start next year a "potentially registrational" Phase II trial of REGN1979 to treat relapsed or refractory follicular lymphoma after reporting an overall response rate (ORR) of 100% in a...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...
19:05 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Fauci details goals of new Ebola trial

The first randomized, controlled trial of potential Ebola therapies conducted during an outbreak has started enrolling patients in the Democratic Republic of Congo. The trial is intended to treat patients who are affected by an...
23:44 , Nov 28, 2018 |  BC Extra  |  Company News

Management tracks: PolarityTE and Foamix hire first chief commercial officers

Regenerative biomaterial company PolarityTE Inc. (NASDAQ:PTE) hired Matt Kemp as chief commercial officer, a newly created position. He was CCO at Dendreon Pharmaceuticals LLC, now owned by Chinese conglomerate Sanpower Group Co. Ltd. (Nanjing, China)....