Phase III
Novartis released results from the Phase III CANOPY-A trial, showing that its canakinumab candidate failed to meet its primary efficacy endpoint in adult NSCLC patients.
The U.K’s MHRA has granted conditional authorization to Moderna’s newest vaccine candidate, making it the first Omicron-specific COVID-19 booster vaccine approved by a regulatory agency.
BrainStorm Cell Therapeutics said it will submit a Biologics License Application to the FDA for ALS hopeful NurOwn. Additionally, a correction has been made to analyses of the Phase III clinical trial.
Roche Wins Approval for Flu Drug in Young Children, Pfizer Touts Positive Results for Infant Vaccine
Roche and Pfizer shared positive news from their respective forays into a new pneumococcal vaccine for infants and a treatment for influenza in small children.
Amgen announced two lung cancer studies with mixed results, Innovent dosed the first patient in a Phase I diabetic macular edema study and HUTCHMED hit the primary endpoint in colorectal cancer.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Using Cerevance’s proprietary NNETSseq technology platform, Merck and Cerevance have partnered to identify new targets for the treatment of Alzheimer’s disease.
BeiGene and Novartis’ unresectable hepatocellular carcinoma treatment, Tislelizumab, is gaining ground as a potential treatment for advanced liver cancer.
The week started off with a clinical bang for Verona Pharma, Kodiak, AstraZeneca and Daiichi Sankyo with wins in COPD, lung cancer and macular edema respectively.
Industry executives often lament the fact that clinical trials take a long time to complete and often fail. BioSpace spoke with Tufts’ Ken Getz about possible reasons and solutions.
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