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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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Leyden Labs secured $140 million in a Series B financing round. Combined with $40 million from a Series A round in March 2021, the company has significant funding to advance its portfolio of candidates.
Biotech companies are partnering with other biotech companies to combine their cutting-edge technology platforms in hopes of opening up new avenues for drug development.
The expert group referred to as “Supermind” shared ideas on five areas over four-weeks last year. Here are some of the highlights.
Cellino is a closed loop cell therapy manufacturing company that aims to make stem cell-based regenerative therapies available to all eligible patients and researchers using cells in clinical research.
Shares of Mustang Bio have fallen more than 13% in premarket trading after announcing the FDA had placed a hold on the company’s Investigational New Drug application for its bubble boy gene therapy.
The Phase III MOMENTUM trial showed that momelotinib was able to meet its primary endpoint by week 24, specifically a TSS reduction of over 50% compared to the baseline figures.
As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
Sixty-three percent of patients met the primary endpoint of a 2-point or greater improvement in disease severity without worsening of fibrosis.
FDA
The FDA cited data demonstrating that both treatments are not likely to be potent against omicron and should not be authorized for use in any U.S. state, territory, and jurisdiction for the time being.
The company submitted its application for AP-188 in early 2021, covering dosage details, formulation, and method of stroke rehabilitation.