JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.
Celgene Corporation today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival.
AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Pfizer Inc. today announced that the REFLECTIONS B7391003 study — a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin (bevacizumab) — met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin.
The U.S. FDA granted full approval for Tagrisso (osimertinib) 80-mg once-daily tablets for treating metastatic EGFR T790M mutation-positive NSCLC.
The new generation of hep C drugs has completely changed the conversation about launches.
Phase I first-in-human study to evaluate GSK’s OX40 agonist GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) LONDON & KENILWORTH, N.J.–(BUSINESS WIRE)–GSK and Merck, […]
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that in the large pivotal Phase II study, BIRCH, the investigational cancer […]
Merck’s immune-boosting cancer drug, Keytruda, bested the standard of care in advanced melanoma, the deadly skin cancer, and showed promising results in non-small cell lung cancer. Based on these data, […]
