New York
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
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.
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.
Pfizer on Monday reported a “strong neutralizing response” against both subtypes of respiratory syncytial virus across all cohorts and age groups, according to topline data.
In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement.
Longeveron and Lexeo Therapeutics are working on CGT therapies to treat Alzheimer’s disease, but it’s not clear whether they have a better chance of success than traditional approaches.
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