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...
21:01 , Mar 15, 2019 |  BC Extra  |  Company News

ICER suggests Novartis' MS therapy siponimod won't be cost-effective

ICER said the price of multiple sclerosis therapy Mayzent siponimod from Novartis would have to reach a monthly net price of $995 to meet its standard cost-effectiveness threshold of $150,000 per QALY. That price would...
00:47 , Feb 23, 2019 |  BioCentury  |  Tools & Techniques

Modeling now for precision later

GNS Healthcare Inc. is building a platform that aims to make value-based payment models unnecessary by giving companies a way to know which patients will respond before they even launch the drug. While drug companies...
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...
20:51 , Dec 19, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Anxiety Mouse studies suggest inhibiting KPNA1 or its downstream mediator the S1P receptor could help treat anxiety. In a mouse model of anxiety, systemic KPNA1 knockout or intrahippocampal injection of an shRNA targeting KPNA1...
03:55 , Dec 7, 2018 |  BC Innovations  |  Tools & Techniques

Filaments line up as MS biomarker

Neurofilament assays appear on track to become the biomarker of choice for a wide range of neurodegeneration studies, given their tight correlation with axon damage and detectability in blood. If prospective trials can reinforce the...
18:25 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA warns of symptom worsening after stopping Gilenya treatment

FDA added a warning to the label of multiple sclerosis drug Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN) saying that patients who stop treatment could experience worsening of symptoms. Gilenya is a first-generation sphingosine 1-phosphate...
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...
17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...