Glaxosmithkline plc (GSK) pledged $2.1 billion up front and as much as $1.2 billion in development milestone payments to take over privately held Affinivax Inc. and bring aboard the phase II-stage, next-generation, 24-valent pneumococcal vaccine candidate, AFX-3772. London-based GSK is buying all outstanding shares of Affinivax, of Cambridge, Mass., for $2.1 billion upon closing the deal in the third quarter of this year, and two potential milestone payments of $600 million to be paid if certain pediatric development goals are reached. Read More
Shares in Swedish biotech firm Rhovac AB collapsed May 30 on news that its therapeutic cancer vaccine, RV-001 (onilcamotide), failed to exhibit efficacy in a phase IIb trial in metastatic prostate cancer. The stock lost 94% of its value when trading opened on the Spotlight junior exchange in Stockholm. Read More
Pharnext SAS has completed recruitment of an FDA-requested second phase III trial of its lead product, PXT-3003, in Charcot-Marie-Tooth disease type 1A (CMT1A), but now needs to raise €50 million (US$53.9 million) to stay solvent until the data read out in Q4 2023. Read More
China has granted a green light for Glaxosmithkline plc’s human papillomavirus (HPV) vaccine, Cervarix, for girls ages 9 to 14. The HPV bivalent vaccine is used against types 16 and 18 in a two-dose course to prevent cervical cancer. It’s the first imported two-dose HPV vaccine for the age group to be approved in China, the company said. A three-dose schedule of Cervarix won Chinese approval in July 2016 for girls and women ages 9 to 25. To date, the two-dose regimen has been approved in about 100 global markets. Read More
China’s National Medical Products Administration (NMPA) released a new draft amendment to its Drug Administration Law (DAL) that introduces some important changes to the regulatory framework and is aimed at codifying initiatives implemented in the current DAL, such as patent linkage and regulatory data protection. Read More
About 56% of the clinical data recorded by BioWorld in 2022 target therapies for oncology, as well as infectious and neurological diseases, but news on COVID-19 efforts continue to dwindle compared with last year. Read More
New hires and promotions in the biopharma industry, including: Aadi, Antev, Brooklyn, Chemocentryx, Dtx, Precision, Seneca, Stipe, Tetra, Theratechnologies, Zentalis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Astrazeneca, Axcella, Bridgebio, Kintara, NLC, Todos. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Bavarian Nordic, Blade, Blue Water, Champions, Checkmate, Cyclica, Denali, Fibrobiologics, Immedica, Immunogenesis, Moderna, NRG, Orphanpacific, Oxford Biotherapeutics, Pharmenable, Regeneron, Relief, Revive, Takeda, Targovax, Transcenta, University of Oxford. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Almirall, Altesa, Amneal, Eisai, Instil, Revive. Read More
