Royalty monetization is a financing tactic that is becoming increasingly popular during challenging times, and PTC Therapeutics Inc. is the latest firm to leverage a marketed drug to pay off debt and fuel its development pipeline. The South Plainfield, N.J.-based company agreed to sell up to $1.5 billion of its Evrysdi (risdiplam) royalty stream to Royalty Pharma plc, of New York. Evrysdi is a survival motor neuron 2 RNA splicing modifier approved by the U.S. FDA in 2020 to treat spinal muscular atrophy. Read More
A new deal between privately held Hummingbird Bioscience Pte. Ltd. and Endeavor Biomedicines Inc. is just one of three antibody-drug conjugate (ADC) agreements reached in the past week, marking a fourth-quarter surge for the therapy. Endeavor has acquired the exclusive, worldwide rights to Hummingbird’s HMBD-501, a HER3-targeted ADC with an exatecan payload. Hummingbird could receive up-front and milestone payments of up to $430 million, along with royalties from net sales. Read More
Elevar Therapeutics Inc. and Hengrui Pharmaceuticals Co. Ltd.’s licensing deal for camrelizumab (SHR-1210; Airuika in China) will add the PD-1 antibody to Elevar’s liver cancer armory for pairing with rivoceranib, its tyrosine kinase inhibitor on the brink of U.S. FDA review. Read More
Fake versions of Novo Nordisk A/S’ 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-management space. Read More
A six-week treatment regimen of Paradigm Biopharmaceuticals Ltd.’s Zilosul (injectable pentosan polysulfate/iPPS) resulted in improvement of both the symptoms of osteoarthritis and preserved or regenerated joint tissues in the knee, according to phase II trial results. Read More
As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.” Read More
In a historic first, the European Commission (EC) sanctioned a pharmaceutical cartel focused on controlling an active pharmaceutical ingredient (API) in the European Economic Area. Read More
Pfizer Inc. entered into a conciliation agreement with the U.S. Department of Labor’s Office of Federal Contract Compliance Programs to resolve alleged compensation discrimination affecting female employees at its New York headquarters. Read More
New hires and promotions in the biopharma industry, including: Actimed, Antiva, Catalyst, Immunome, Macomics, Nurexone, Omeros, Regcell, Summit, Y-mabs. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ayala, Basilea, Beam, Biosight, Eli Lilly, Geneuro, Gigagen, Gilead, Gravitas, Mablink, Microvascular, Oxford Nanopore, Pfizer, Qnovia, Seagen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Ardelyx, Astrazeneca, Bio4t2, Brainstorm, Caribou, Celularity, Hyloris, Intellia, Mirum, Novavax, Orasis, Sage, Tiziana, UCB, Ymabs. Read More
