Drug Development
Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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During the second quarter, NRx reactivated the development of NRX-101 and intends to initiate a Phase IIb/III study for ASIB by the end of this year or early 2023.
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.
The 3D-printed acoustic hologram could be very important to the delivery of certain therapeutics for Alzheimer’s Disease (AD) and other neurological disorders.
This week holds moments of truth for Provention’s type 1 diabetes drug and bluebird bio’s gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
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.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
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.
Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.