Lilly said it expects the drugs to remain in tight supply, but plans for significant production increases in the second half of the year.
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Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment.
Ono Pharmaceutical said Monday it will pay $2.4 billion to acquire Deciphera Pharmaceuticals for cancer drugs that could generate peak annual sales of more than $1 billion.
According to Repertoire, the deal will use its Decode discovery platform to find the vaccine candidates. Decode is a T cell receptor-epitope platform using proprietary lipid nanoparticle delivery technology. The biotech said that the vaccines will aim to treat the underlying causes by “resetting” the immune system.
Yesterday a U.S. judge rejected a challenge by Bristol Myers Squibb and Johnson & Johnson to a law requiring them to negotiate the prices of their blockbuster blood clot prevention drugs with the U.S government’s Medicare health insurance program or pay heavy penalties.
A Phase II study funded by the National Institutes of Health found that a dose-sparing, intradermal regimen of Bavarian Nordic’s intradermal mpox vaccine Jynneos (modified vaccinia Ankara-Bavarian Nordic) can match the antibody response elicited by the standard-dose regimen.
X4’s mavorixafor, to be sold under the brand name Xolremdi, is the first therapy to get U.S. approval specifically for the treatment of WHIM syndrome.
With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
After a years-long drought, progress in the amyotrophic lateral sclerosis (ALS) space began to accelerate with the 2022 approval of Amylyx’s Relyvrio and Biogen and Ionis’ Qalsody in 2023. But now, that progress appears to have stalled. Earlier this month, Amylyx announced it would pull Relyvrio from the market after a failed Phase III trial, and closely watched trials from Seelos Therapeutics and Sanofi and Denali Therapeutics recently missed their primary endpoints.