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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.
Plexxikon, which was acquired by Daiichi Sankyo, and Novartis have agreed to settle a patent case involving the cancer drug Tafinlar and its sale in the U.S.
As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.
The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.
For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
While almost half of multiple myeloma patients on linvoseltamab achieved a complete response or better, all experienced adverse events and 14 patients died due to treatment-emergent AEs.