00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month's gains and losing $291.2 billion in aggregate value. Median losses...
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...
00:50 , Jan 5, 2019 |  BC Extra  |  Company News

Flurry of management moves on eve of JPM

More than 30 biopharma companies announced executive changes to kick off the New Year, including Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and Immunocore Ltd. (Abingdon, U.K.), both of which brought on former AstraZeneca plc (LSE:AZN; NYSE:AZN) executives...
19:07 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
01:29 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Alexion gains early approval for long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) received FDA approval for Ultomiris ravulizumab-cwvz (ALXN1210), the biotech's long-acting formulation of Soliris eculizumab, to treat paroxysmal nocturnal hemoglobinuria. While the approval came nearly two months ahead of the Feb. 18...
12:06 , Jan 3, 2019 |  BC Extra  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
21:26 , Dec 31, 2018 |  BC Extra  |  Politics & Policy

FDA closes 2018 with record NME approvals

FDA ended 2018 with a record 59 new molecular entity approvals, up from 46 in 2017. The agency's previous approval record was 53 in 1996, the all-time high in FDA's published data. As of Dec....
23:31 , Dec 21, 2018 |  BC Extra  |  Company News

Alexion gains early approval for long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) received FDA approval for Ultomiris ravulizumab-cwvz (ALXN1210), the biotech's long-acting formulation of Soliris eculizumab, to treat paroxysmal nocturnal hemoglobinuria. While the approval came nearly two months ahead of the Feb. 18...
19:26 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...
19:26 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Achillion discontinuing PNH monotherapy

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) said it will discontinue development of ACH-4471 as oral monotherapy treatment of paroxysmal nocturnal hemoglobinuria in favor of an earlier stage compound. The decision is a delay for Achillion as it...