FDA

The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.

The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.  

Roche on Sunday released results from the first stage of the Phase III OUtMATCH study, demonstrating that its asthma drug Xolair (omalizumab) can significantly reduce severe allergic reactions in patients with several food allergies.

GlaxoSmithKline, GSK

British drugmaker GSK said on Monday its oral drug to treat gonorrhea met the main goal of non-inferiority, compared to an existing combination treatment, in a late-stage trial.

Indian pharma companies have started developing their own versions of Novo Nordisk’s top-selling weight-loss medicine Wegovy (semaglutide), hoping for a piece of the multibillion-dollar obesity market.

Frontier Medicines on Thursday closed its oversubscribed $80 million Series C funding round,  which it will use to advance its potentially first-in-class next-generation KRAS blocker FMC-376.

San Francisco-based Rigel Pharmaceuticals on Thursday announced it will acquire the U.S. rights to Blueprint Medicines’ FDA-approved non-small cell lung cancer drug Gavreto (pralsetinib).

On the heels of Takeda’s $300 million licensing deal for rusfertide, Protagonist Therapeutics’ peptide mimetic lowered hematocrit levels in patients with polycythemia vera, a type of blood cancer.

After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.

According to Bavarian Nordic, its cancer vaccine TAEK-VAC has reached a stage where more investments are required. The company would also have faced stiff competition in the cancer vaccine space.