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Treatment with the TROP2 ADC sac-TMT led to a 70% objective response rate and progression-free survival was “significantly improved” as compared to placebo—the second positive readout for the asset this week.
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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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Codagenix is entering the vaccine arena with a possible new frontrunner in protection: CoviLiv. It’s an intranasal COVID vaccine that provides hope against subvariants.
Biopharma and life sciences companies continue to strengthen their executive teams and boards with this week’s Movers & Shakers.
U.S. and Chinese regulators are edging toward a cooperation plan on Chinese companies that have stock listed on U.S. stock exchanges.
Alexion will pay Chugai $775 million in the second quarter of 2022 in exchange for the Japanese firm withdrawing the patent infringement lawsuits it filed in Europe, Japan and the U.S.
FDA
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
Alnylam is suing Moderna and Pfizer over patent infringements related to its lipid techQnology that have been foundational to the success of the mRNA-based COVID-19 vaccines.
This is the first approval for the drug in gastroenterology and was based on data from three Phase III trials.
FDA
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
On Wednesday, the World Health Organization indefinitely postponed the evaluation of Russia’s Sputnik V COVID-19 vaccine due to the ongoing conflict in Ukraine.