News

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.
FEATURED STORIES
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.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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
New Phase II data, published in the New England Journal of Medicine, showed Lilly’s oral GLP-1 receptor agonist orforglipron induced nearly 15% weight loss in obese and overweight adults.
CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental treatment.
Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.
FDA
Shares of Sarepta dropped 11% a day after securing accelerated approval for the first gene therapy to treat Duchenne muscular dystrophy over concerns about the potential for label expansion.
Under the merger announced Thursday, Tourmaline shareholders will own nearly 80% of the new company, which will retain its name and continue to focus on developing its anti-IL 6 antibody.
The government asked a federal judge to overturn a verdict in which a Delaware jury ruled in favor of Gilead, deciding that its preventative HIV drugs Truvada and Descovy did not infringe on its patents.