The tumor microenvironment is critical for the ability of cancers to survive and grow, and some aspects of the microenvironment are studied, and targeted, accordingly. Tumor immunology is one of the most active areas of cancer research and has become a pillar of treatment. Others, not so much. “The nervous system is the last component of the microenvironment that people have left completely unrecognized,” Humsa Venkatesh told BioWorld. Even in brain tumors and metastases, where the presence of neurons is glaringly obvious, there has been little attention to how the two interact until recently. Read More
Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
Through a $600 million deal, Juniper Biologics Pte. Ltd. has acquired rights from Kolon Life Science Inc. to develop and commercialize TG-C LD (Tissuegene-C low dose) for the treatment of knee osteoarthritis. Singapore-based Juniper will hold the rights for Asia Pacific, the Middle East and Africa and be responsible for developing and commercializing the candidate within those regions. Read More
Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to two candidates from Lenz Therapeutics Inc. for the treatment of presbyopia in greater China in a deal worth up to $110 million. San Diego-based Lenz will receive $15 million in up-front payments, up to $95 million in regulatory and commercial milestone payments, and potential royalty payments based on net sales. Read More
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market. Read More
It’s been one thing after another for rusfertide from Protagonist Therapeutics Inc. for the past year. Now the U.S. FDA has told the company it wants to rescind the breakthrough designation, a relatively rare occurrence, based on observed malignancies in a follow-up to September’s clinical hold. Read More
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld. Read More
Aurion Biotech Inc. pulled down a $120 million financing to advance efforts with its lead candidate, a cell therapy for the treatment of corneal edema secondary to endothelial dysfunction (CESED). Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Alpine, Apexigen, Basilea, Biopath, CG, Chemocentryx, Cstone, Deciphera, Erasca, Gritstone, Highlight, Kineta, Mustang, Neoimmunetech, Neoleukin, Oric, Portage, Sotio, Trishula.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adiso, Addex, Amryt, Imcyse, Lineage, Medicinova, Oncternal, Phosplatin, Recce, Sonnet, Syneurx, Turning Point. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Dyadic, Epygen, Emergex, Excellthera, Hookipa, Inotrem, Insilico, Gain, Geneuro, ICER, Longeveron, Magenta, Matinas, Micros, Oncolytics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Atyr, Biogen, Boehringer, Briacell, Direct, Eli Lilly, Novavax, Recbio. Read More
