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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 validating 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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Big Pharma had plenty of drama to keep journalists busy this quarter, which painted an accurate portrait of the wild and wonderful world of biopharma.
Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.
BMS has so far been on a winning streak in the contingent value right cases, which allege that the pharma intentionally delayed regulatory activities for Breyanzi in order to avoid a $6.4 billion payout to Celgene shareholders.
Gilead’s layoffs include 72 employees at its Seattle location, which will close. Kite will shut down its Philadelphia facility. The layoffs are attributed to aligning resources with long-term strategic goals.
The November layoffs are the second known workforce reduction this year for Marinus Pharmaceuticals, which previously announced disappointing Phase III results for ganaxolone in two clinical trials.
Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.
Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class.
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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.