The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Bristol Myers Squibb inked a licensing deal for Agenus’ proprietary bispecific antibody program, AGEN1777, and a second undisclosed target. AGEN1777 is an Fc-enhancement antibody Agenus is developing to target major inhibitory receptors found on T and NK cells that seem to improve anti-tumor activity.
Pfizer reported first-quarter 2021 revenue of $14.6 billion, an impressive 42 percent operational growth. The company’s Covid-19 vaccine revenue accounted for $3.5 billion of the total.
Roche announced topline data from two identical Phase III trials (TENAYA and LUCERNE) of faricimab in neovascular or “wet” age-related macular degeneration (nAMD), with both studies hitting their primary endpoint.
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Immunocore’s Phase III IMCgp100-202 trial of tebentafusp compared to investigator’s choice for metastatic uveal melanoma (mUM) met the pre-defined boundaries for statistical significance of the primary endpoint of overall survival in its first pre-planned interim analysis.
Mumbai-based Glenmark Pharmaceuticals is spinning off its innovation business into a U.S.-based standalone company.
AbbVie Inc., along with Teneobio Inc. and that company’s affiliate TeneoOne Inc., announced that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma.
Roche named U.S. cancer expert William Pao head of the Swiss drugmaker’s Pharma Research and Early Development business after John Reed decided to leave for what it called personal reasons.
Genentech announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema, treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone.