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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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In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
The FDA on Monday only granted Liquidia’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.
The Danish company on Saturday announced plans to increase production of its vaccine Jynneos on the heels of the World Health Organization last week declaring mpox a global health emergency.
SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.
The unit’s closure comes as Genentech’s parent Roche rethinks its cancer business, an effort that has included the discontinuation of three early-stage candidates and a T-cell partnership with Adaptimmune.
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Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.
For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous.