23:28 , Jun 26, 2019 |  BC Innovations  |  Distillery Therapeutics

Induction of NFE2L2 activity for Alzheimer's disease

DISEASE CATEGORY: Neurology INDICATION: Alzheimer's disease (AD) Inducers of NFE2L2 activity could help treat AD. Postmortem brain tissue from seven AD patients had lower NFE2L2 protein levels than tissue from seven control donors, and low...
00:43 , Mar 22, 2019 |  BioCentury  |  Finance

Biogen's lead balloon

Biogen took a 29% haircut to $226.88 on Thursday following its decision to discontinue the Phase III ENGAGE and EMERGE trials of aducanumab for Alzheimer’s disease. The company's stock price has been dragged down 48%...
12:30 , Mar 21, 2019 |  BC Extra  |  Clinical News

Biogen, Eisai discontinuing aducanumab studies in AD

Biogen and Eisai said aducanumab is unlikely to meet the primary endpoints of two Phase III trials to treat early Alzheimer's disease, joining a long list of failed mAbs against β amyloid and putting more...
02:36 , Feb 28, 2019 |  BC Week In Review  |  Clinical News

FDA accepts NDA for multiple sclerosis prodrug from Alkermes, Biogen

Alkermes plc (NASDAQ:ALKS) said FDA accepted for review an NDA for diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis. The PDUFA date is in 4Q19. The company submitted the NDA submitted under under...
19:59 , Feb 15, 2019 |  BC Week In Review  |  Company News

PTAB to review Biogen's Tecfidera patent

The U.S. Patent Trial and Appeal Board will review a patent held by Biogen Inc. (NASDAQ:BIIB) covering methods of treating multiple sclerosis with Tecfidera dimethyl fumarate. Mylan N.V. (NASDAQ:MYL) filed the inter partes review (IPR)...
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...
01:19 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Alkermes submits NDA to FDA for Biogen-partnered MS candidate

Alkermes plc (NASDAQ:ALKS) submitted an NDA to FDA under under section 505(b)(2) of the Food, Drug and Cosmetic Act seeking approval of diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis. Alkermes' partner Biogen...
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...
13:51 , Nov 19, 2018 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
18:10 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....