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Mirati gets EC approval for Krazati to treat KRASG12C mutated NSCLC
EC has cleared Adagrasib as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after a minimum of one prior systemic therapy
NovaBay signs agreement with Sonoma to sell Avenova-branded products in EU
The collaboration leverages NovaBay’s extensive expertise in eye care, demonstrated by its Avenova brand, and Sonoma’s ability to distribute hypochlorous acid products internationally
AbbVie introduces Produodopa for Parkinson’s disease in EU
AbbVie has launched the solution to treat PD with severe motor fluctuations and hyperkinesia or dyskinesia, and when existing combinations of Parkinson’s medicinal products have not delivered positive results
Venatorx grants cefepime-taniborbactam’s rights to Menarini Group
Under the agreement, Menarini will buy the exclusive rights to commercialise cefepime-taniborbactam in 96 countries in return for a licensing fee, R&D payments, regulatory, sales-based milestone payments
Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye
AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease
TIVDAK Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
Merck to buy cancer drug maker Harpoon Therapeutics for $680m
The acquisition will grant Merck access to Harpoon’s two immunotherapies in early-stage development, one for a type of lung cancer and the other for multiple myeloma
Novartis in advanced discussions to acquire Cytokinetics
The deal is expected to grant Novartis access to Cytokinetics’ experimental treatment for hypertrophic cardiomyopathy treatment, Aficamten, which met the primary endpoint in a late-stage trial
Biocytogen enters into Bispecific Antibody Drug Conjugate agreement with Radiance Biopharma
The agreement grants Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate for therapeutic product development, manufacturing and commercialisation for all human indications worldwide
Curevo’s shingles vaccine Amezosvatein meets primary endpoint in Phase 2 trial
In the trial, the vaccine demonstrated non-inferiority to Shingrix as measured by humoral immune response along with reduced rates of requested systemic and local adverse events