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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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Elizabeth Holmes, the founder and former CEO of Theranos, has been found guilty of bilking hundreds of millions of dollars from investors to prop up her company.
Biogen exercised an option to pick up an exclusive global license for a drug to treat spinal muscular atrophy from Ionis. The compound, BIIB115, is an antisense oligonucleotide.
Three IPO aspirants have stepped up at the start of the new year: CinCor Pharma, Amylyx and Applied UV
This California biotech just bagged another partner for its endeavor to cure autoimmune disease with cell therapy.
Data from pre-clinical studies show that OV350 may be developed to treat multiple types of epilepsy and other CNS conditions, including neurodevelopmental diseases.
Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.
Applied Therapeutics said it is holding off on a New Drug Application after discussions with the FDA, which appears to require additional clinical data.
Just as 2021 was wrapping up, the U.S. FDA had some end-of-year activity. Here’s a look.
Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
Right now, Kidd’s focus is on ensuring the company is ready for late-stage development and commercialization activities.