The significant risks and high costs associated with neurological R&D has tended to keep companies and investors on the sidelines over the past few years. However, thanks to research progress and the development of new technologies, business development and investing in the space is heating up once again.
In an unusual move, three members of the Nov. 6 FDA advisory committee that voted against recommending approval of Biogen Inc.’s high profile Alzheimer’s disease candidate, aducanumab, have doubled down on their argument in an editorial published in JAMA on March 31.
Scribe Therapeutics Inc. raised $100 million in a series B round to continue its engineering-intensive approach to developing CRISPR-based therapies that employ custom-designed CasX enzymes.
According to an analysis conducted by BioWorld of the 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the year increased by 23% compared to the same period last year.
Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
A decade from now, 2020 likely will be considered a year like no other in terms of the massive amounts of capital raised amid a raging pandemic. Financing transactions of all types smashed records and in terms of volume hit 1,580, a total that was 42% higher than last year.
A decade from now, 2020 likely will be considered a year like no other in terms of the massive amounts of capital raised amid a raging pandemic. Financing transactions of all types smashed records and in terms of volume hit 1,580, a total that was 42% higher than last year despite the serious disruptions to normal business operations.
The whopper deal between Biogen Inc. and Sage Therapeutics Inc. – a global collaboration and licensing deal involving the latter’s zuranolone (also known as SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, as well as SAGE-324 for essential tremor (ET) and neurological disorders – drew mixed reviews from Wall Street. And, for Biogen investors, the would-be Alzheimer’s disease (AD) therapy aducanumab remains front of mind.
Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.
