The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope. Read More
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint. Read More
Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Shanghai-based Nuance plans to run its own phase I and phase III trials in China to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic's own phase III trial planned to begin in the first half of 2022. Read More
While the focus of much U.K. Chancellor Rishi Sunak’s spring statement 2022 was on the rising cost of living, there was welcome relief for life sciences and research-based industries as part of a drive to restore economic growth. Read More
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access. Read More
New hires and promotions in the biopharma industry, including: Arrepath, Creyon, Epiendo, Epygenix, Imago, Imbria, Medicure, Mesoblast, Phosplatin, Puretech, Sosei, Verastem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Alligator, Carsgen, Janssen, Moderna, Pfizer, Pharmather, Pluristem, Rani, Rezolute, Ribomic, Servatus, South Rampart, Telix, Tryp, Urovant, Vivavision, XNK. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Biodelivery, Bullfrog, Collegium, Neonmind, Quretech, Vaxxas, Vectivbio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery. Read More
