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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.
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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.
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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.
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Vertex Pharmaceuticals announced positive Day 90 data from the first patient in its Phase I/II study of VX-880 in type 1 diabetes.
Phathom announced positive results from its Phase III trial, PHALCON-EE, comparing vonoprazan against lansoprazole in patients with moderate to severe erosive esophagitis.
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
Omeros Corporation shares were down in premarket trading after the company received a CRL for its experimental hematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.
Biogen announced topline results from the Phase III VALOR trial of tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
Cartesian’s Descartes-08 is a new chimeric antigen receptor (CAR) - T cell therapy that strives to target the myasthenia gravis disease at its source.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.
The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
Read about TFF Pharmaceuticals and Augmenta Bioworks’ dry powder COVID-19 antibody formula, the world’s first gene editing clinical trial for PKU, Bayer’s COVID-19 vaccine and other key developments in life sciences research.