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

Merck’s Phase 3 Keynote- A18 trial met PFS in patients with advanced cervical cancer

KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients

Kintor Pharma completes first patient enrollment in long-term safety phase III trial of KX-826

The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023

M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData

CMOs showed an increasing reluctance to take on debt in 2022

Sandoz plans to build a Biosimilar Technical Development Center in Slovenia

Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026

Dupixent is now approved in India for the treatment of adults with moderate-to-severe atopic dermatitis

Briefs: Link Pharma Chem and Zydus

USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad

Sumitomo Pharma America launches as new combined organization

SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU

Cytel acquires French group stève consultants to expand real-world analytics capabilities

Cytel excels at using proven quantitative techniques to transform real-world data into actionable insights