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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavenos
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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Allogene Therapeutics and Arbor Biotechnologies will use their allogeneic CAR T and next-generation gene-editing platforms to develop novel off-the-shelf CAR-T therapies for autoimmune diseases.
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
A controversial decision by the Alabama Supreme Court temporarily chilled IVF before igniting nationwide pushes to protect access to this type of fertility treatment, leaving drugmakers with questions.
Vertex and CRISPR Therapeutics are setting up treatment centers for patients with beta thalassemia and sickle cell disease to compete with bluebird’s established infrastructure.
Synthetic biology company Pearl Bio announced Tuesday it has entered into a license and collaboration agreement with Merck to discover biologic therapies comprising non-standard amino acids.
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.
Bristol Myers Squibb has pulled the plug on a more potent version of its cancer immunotherapy Yervoy. However, the two companies will continue to work on other collaborative programs for T-cell engagers.
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023.
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals.