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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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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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The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.
With no well-controlled data to support its efficacy, the FDA rejected Aldeyra’s methotrexate injection for primary vitreoretinal lymphoma.
Pieris Pharmaceuticals announced partner AstraZeneca’s decision to discontinue clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor, based on a non-clinical toxicology study.
The majority of ALS patients are excluded from clinical trials. Experts say using biomarkers and stratifying trial populations can expand eligibility and provide additional scientific insights.
On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The Huntington’s disease space saw a flurry of activity Wednesday as PTC and uniQure released data from their respective mid-phase trials.
Argenx’s Vyvgart will now be available in the U.S. as a more convenient subcutaneous formulation 18 months after its first approval.
The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.