Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial

Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease

Biocon Biologics gets EMA’s positive opinion for an ophthalmology product

Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin

Good momentum in commercial CDMO business

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU