BioCentury | Mar 16, 2021
Product Development

The clinical pipeline for Alzheimer’s disease: Data Byte

Although amyloid-lowering agents still represent the lion’s share of late-stage candidates for Alzheimer’s disease, they account for less than 20% of compounds across all clinical stages. Tau inhibition, modulation of neurotransmitter signaling, and quelling of...
BioCentury | Feb 27, 2021
Emerging Company Profile

Orna: turning circular RNAs into therapies

Orna emerged from stealth Wednesday with an $80 million A round to develop circular RNA therapies for cancer and genetic diseases that could be easier to manufacture than linear RNAs and immune cell therapies. MPM Capital,...
BioCentury | Feb 19, 2021
Translation in Brief

mAb reduces amyloid plaques without hemorrhage; plus Dyno and Ally’s AAV technologies and more

Alzheimer’s disease immunotherapy reduces β-amyloid without increasing brain bleedingPublished in Science Translational Medicine, Denali Therapeutics Inc. (NASDAQ:DNLI) and Washington University School of Medicine in St. Louis researchers led by David Holtzman found that an anti-APOE...
BioCentury | Jan 30, 2021
Regulation

Biogen’s remaining options to bolster aducanumab’s case as PDUFA is extended

It’s unclear whether FDA is calling for more data from Biogen because it is looking for a rationale to approve aducanumab against the recommendation of its advisers, or whether it’s primarily stalling for time, avoiding...
BioCentury | Jan 7, 2021
Finance

Weill Cornell spinout Lexeo raises $85M series A to develop clinical gene therapy programs

With a portfolio of three gene therapy programs from Weill Cornell, two of which have already reached the clinic, start-up Lexeo has drawn $85 million in series A funding from a syndicate led by Longitude Capital...
BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...
BioCentury | Nov 10, 2020
Product Development

Pfizer & Biogen: The good, the bAD and what’s next

COVID-19 vaccine data from Pfizer and BioNTech have set a high bar for what could be a rapid wave of readouts from other companies developing vaccines accelerated by surges in case counts. In the latest...
BioCentury | Nov 7, 2020
Regulation

Aducanumab panel criticizes FDA as it rebukes Alzheimer’s candidate

FDA’s advisers not only roundly rebuffed Biogen’s Alzheimer’s candidate aducanumab, tanking its odds of approval, they also lambasted the agency for bias in its presentation of the analyses. In Friday’s meeting of the Peripheral and...
BioCentury | Nov 5, 2020
Product Development

FDA signals relatively clear path ahead for Alzheimer’s therapy aducanumab

FDA appears to be leaning toward approval of the first theoretically disease-modifying therapy for Alzheimer’s disease, or any neurodegenerative disorder, based on two incomplete Phase III trials, one...
BioCentury | Aug 31, 2020
Deals

Three years after spinout, Ionis brings back Akcea in $500M acquisition

...and AKCEA-TTR-LRx, in Phase III for ATTR amyloidosis.Two pipeline programs are partnered with pharma companies. AKCEA-APO(a)-LRx...
Items per page:
1 - 10 of 1086