News
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
FEATURED STORIES
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
In a filing with the SEC, Abbvie’s decision to terminate came after the two firms jointly conducted a review of their next steps for the drug.
With one in three employed women in the U.S. also raising children at home, and the majority of U.S. moms working at least part-time, moms are working overtime to keep up with their male counterparts.
Ramesh “Sunny” Balwani, Elizabeth Holmes’ former business and romantic partner, was found guilty of all 12 fraud charges brought against him for his role in the Theranos scandal.
Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
With COVID-19 vaccination rates dropping, millions of doses are going to waste. Meanwhile, outdoors isn’t sure-fire protection but long-term intermittent fasters may be spared severe disease.
Adagio, Aravive, PolyPid, Harpoon, Durect, Nitrase, Kallyope, TScan and many more made major leadership decisions this week.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
When GSK’s consumer health spinoff Haleon launches later this month, the new business will carry more than $12 billion in debt when it lists on the London Stock Exchange.
Portage Biotech announced Wednesday that it has inked an acquisition agreement with New York-based Tarus Therapeutics, adding four new candidates to its pipeline.