00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
01:54 , Feb 8, 2019 |  BC Week In Review  |  Clinical News

FDA approves Sanofi's Cablivi for rare clotting disease

Sanofi (Euronext:SAN; NASDAQ:SNY) said FDA approved Cablivi caplacizumab-yhdp to treat acquired thrombotic thrombocytopenic purpura (aTTP), making it the first FDA-approved therapy for the rare blood clotting disorder. Sanofi will launch the drug late this quarter...
17:51 , Feb 6, 2019 |  BC Extra  |  Company News

FDA approves Sanofi's Cablivi for rare clotting disease

Sanofi (Euronext:SAN; NASDAQ:SNY) said FDA approved Cablivi caplacizumab-yhdp to treat acquired thrombotic thrombocytopenic purpura (aTTP), making it the first FDA-approved therapy for the rare blood clotting disorder. Sanofi will launch the drug late this quarter...
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...
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...
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...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
18:30 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Sanofi's Cablivi gains EU approval, Priority Review in U.S.

Sanofi (Euronext:SAN; NYSE:SNY) said the European Commission approved Cablivi caplacizumab to treat rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). The company also revealed Sept. 3 that FDA accepted and granted Priority Review to...
18:18 , Sep 3, 2018 |  BC Extra  |  Company News

Sanofi's Cablivi gains EU approval, Priority Review in U.S.

Sanofi (Euronext:SAN; NYSE:SNY) said the European Commission approved Cablivi caplacizumab to treat rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). The company also revealed Monday that FDA accepted and granted Priority Review to its...
20:07 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a...