21:59 , Apr 25, 2019 |  BC Extra  |  Company News

Salix licenses S1P receptor modulator from Mitsubishi

Mitsubishi has found a new partner for its oral S1P receptor modulator in Salix, two years after Biogen decided to return its rights to the compound. Salix Pharmaceuticals Ltd. gained exclusive rights Thursday to develop...
00:37 , Mar 27, 2019 |  BC Extra  |  Company News

FDA approves Novartis' Mayzent for MS

FDA's approval of Novartis’ Mayzent siponimod late Tuesday with a broad label could position the multiple sclerosis drug to stand out from a crowded field with its approval for secondary progressive MS, an indication for...
22:56 , Mar 25, 2019 |  BC Extra  |  Company News

Celgene resubmits NDA for MS candidate ozanimod

Celgene said it resubmitted an NDA to FDA for ozanimod to treat relapsing forms of multiple sclerosis. The company submitted earlier this month an MAA to EMA for the selective S1PR1 and S1PR5 modulator. Last...
05:09 , Jan 5, 2019 |  BioCentury  |  Product Development

Bristol-Myers’ next phoenix act?

Bristol-Myers Squibb Co. will now be in the driver’s seat to monetize the assets gained from the myriad deals Celgene Corp. has forged. The pharma will need to mimic its history of using well-timed acquisitions...
17:34 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

FDA, EMA to review Novartis' siponimod for secondary progressive MS

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and MAA have accepted applications for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS). The PDUFA date for the NDA is in March 2019; Novartis expects a decision...
18:27 , Oct 8, 2018 |  BC Extra  |  Company News

FDA, EMA to review Novartis' siponimod for secondary progressive MS

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and MAA have accepted applications for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS). The PDUFA date for the NDA is in March 2019; Novartis expects a decision...
18:11 , May 4, 2018 |  BC Extra  |  Company News

Celgene to resubmit ozanimod NDA in 1Q19, updates guidance

Celgene Corp. (NASDAQ:CELG) said in its 1Q18 earnings that it plans to submit regulatory applications to FDA and EMA for relapsing multiple sclerosis candidate ozanimod in 1Q19. The timeline settled uncertainty among analysts whose submission...
20:00 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Metabolite drives activity of Celgene's ozanimod

New data from Celgene Corp. (NASDAQ:CELG) showed that a metabolite of ozanimod accounted for the "majority" of the total activity of the relapsing multiple sclerosis candidate in humans. The revelation may provide a clue as...
22:08 , Apr 26, 2018 |  BC Extra  |  Clinical News

Metabolite drives activity of Celgene's ozanimod

New data from Celgene Corp. (NASDAQ:CELG) showed that a metabolite of ozanimod accounted for the "majority" of the total activity of the relapsing multiple sclerosis candidate in humans. The revelation may provide a clue as...
22:51 , Apr 6, 2018 |  BioCentury  |  Finance

Picking season

  Macroeconomic risks, surging volatility and a tail-off in the M&A market since January have done little to change the buyside’s strategy of overweighting small- and mid-cap biotechs. In fact, the 12 investors who spoke...