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)...
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...
22:52 , Jan 15, 2019 |  BC Week In Review  |  Company News

AZ's Bohen departing after cancer-focused tenure

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Sean Bohen is leaving as CMO and EVP of global medicines development after a tenure marked by mixed results for the pharma's checkpoint inhibitor. Shortly after Bohen joined the pharma...
23:49 , Jan 14, 2019 |  BC Extra  |  Company News

AZ's Bohen departing after cancer-focused tenure

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Sean Bohen is leaving as CMO and EVP of global medicines development after a tenure marked by mixed results for the pharma's checkpoint inhibitor. Shortly after Bohen joined the pharma...
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...
23:44 , Nov 1, 2018 |  BC Extra  |  Company News

FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder. Panelists also voted 20-3 that...
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....