Novartis AG, keen to expand its central nervous system franchise as generics chase down crown jewel Gilenya (fingolimod), has secured rights from UCB SA to co-develop and commercialize two potential Parkinson's disease therapies for $150 million up front and milestone payments approaching $1.5 billion. Read More
While discussing positive data on its lead candidate lenzilumab for treating hospitalized COVID-19 patients, Humanigen Inc.’s CEO sparred a bit with the FDA and its refusal to grant the treatment emergency use authorization. The monoclonal antibody, Cameron Durrant told investors on a Dec. 2 call, could possibly have saved 60,000 to 70,000 patients while the company waits for another meeting with the FDA. Read More
LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial. Read More
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023. Read More
LONDON – Aviadobio Ltd. has raised $80 million in a series A round to take a precision microdosed gene therapy for treating familial frontotemporal dementia into a phase I/II clinical trial. Read More
Tune Therapeutics Inc. launched with $40 million in initial financing and plans to pursue both rare and complex disease indications with a series of epigenetic editors that employ CRISPR-Cas9 DNA recognition to modulate gene expression in a targeted fashion, without introducing potentially problematic DNA strand breaks or changes to the genetic code. Read More
The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine. Read More
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer. Read More
New hires and promotions in the biopharma industry, including: Abcellera, Albireo, Alpha Cognition, Appia, Atriva, C4X, Harbour, Monte Rosa, Novartis, Ona, Replimune, Sernova, Vizgen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cocrystal, Codiak, Entos, EOM, Fusion, Glaxosmithkline, Highlight, Huyabio, Immunocellular, Medigene, Moderna, Omeros, Orexo, Rayner, Shanghai Jemincare, Soligenix, University of Montréal, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Beyondspring, Bionomics, Bioxcel, CTI, Cytodyn, Harmony, Huyabio, Innovent, Merck, Moleculin, Ridgeback, Shenzhen Chipscreen, Secura, Siga, Statera, Surface, Telix, VBI, Zogenix. Read More
