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
Ecnoglutide, which Pfizer licensed from Sciwind Biosciences, is already approved in China for type 2 diabetes mellitus, and a marketing application for weight loss has been accepted by regulatory authorities in the country.
Following a disappointing Phase 3 performance and given Gossamer Bio’s balance sheet, seralutinib’s path to the market for pulmonary arterial hypertension has become unclear, according to analysts at Guggenheim Partners.
In a Phase 1 study, 82% of patients on VIR-5500 achieved at least a 50% reduction in PSA levels—a result analysts praised as competitive in the prostate cancer space.
Part of AbbVie’s vow to invest $100 billion in the U.S. over the next decade, the two Illinois facilities will make active ingredients for next-generation neuroscience and obesity drugs when they start operations in 2029.
Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers.
The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.
The new structure will help Merck as it slides toward a loss of exclusivity for Keytruda, pharma’s best-selling drug.