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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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Novartis, GlaxoSmithKline and Sanofi have announced plans for significant cutbacks and changes in their labor force overseas for financial, operational and logistical reasons.
Enliven Therapeutics and Imara will merge in an all-stock deal to form a precision oncology company. The new entity will operate under the name Enliven Therapeutics.
Matchpoint Therapeutics hit the ground running Friday with $100 million in investments and a focus on developing precision small molecule medicines.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Verseon has acquired Edammo, an artificial intelligence-focused company, to deepen its own AI-based drug discovery platform. Financial terms were not disclosed.
The Biotechnology Innovation Organization, Passage Bio and Palisade Bio saw leadership shakeups at the top, while Maze Therapeutics, Cerecin and more appointed new chief medical officers.
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.