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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.
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.
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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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Denali Therapeutics, Inc. has announced that dosing has begun for participants of a Phase II clinical trial that intends to evaluate the potential of SAR443820 (DNL788) in patients with amyotrophic lateral sclerosis (ALS).
Biogen announced the leadership change in its quarterly financial report. Michel Vounatsos plans to depart the company when a new CEO is found.
Teva announced that it had reached a deal with Lupin over Lupin’s Abbreviated New Drug Application (ANDA) for generic deutetrabenazine - an upcoming competitor to Hungtington’s drug Austedo.
Dianthus Therapeutics launched today with $100 million in Series A financing led by 5AM Ventures, Avidity Partners and Fidelity Research and Management. The company plans to tackle severe and rare autoimmune diseases by utilizing antibodies that target complements.
Humacyte’s engineered blood vessels, human acellular vessels, are in a position to take tissue regeneration from a laboratory possibility to a commercial reality.
Therapeutic Solutions International is targeting long COVID with a new stem cell therapy, as Tonix and Pfizer explore their own treatment options.
What sets Verseon apart is its use of molecular physics modeling to enable the atomic-level engineering of new molecules. The company has 14 small molecule drugs in development.
The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.