Dupixent (dupilumab) continues to expand its scope, this time by hitting primary and all key secondary endpoints in a phase III study of treating chronic obstructive pulmonary disease (COPD). Data from the placebo-controlled clinical trial make the anti-inflammatory the first and only biologic that has showed a clinically meaningful and significant reduction in worsening COPD-related moderate or severe respiratory problems. Dupixent, a fully human monoclonal antibody being developed by Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, is already approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis.

FDA delivers CRL to Incyte regarding NDA for once-daily Jakafi

Incyte Corp. said the U.S. FDA issued a complete response letter (CRL) for ruxolitinib extended-release tablets for once-daily use in treating certain types of myelofibrosis, polycythemia vera, and graft-vs.-host disease. The Janus kinase inhibitor was previously cleared for those indications in a twice-daily version under the brand name Jakafi, which scored its first green light in November 2011. The CRL agrees that the findings submitted in the NDA package show bioequivalence with Jakafi, but regulators “identified additional requirements for approval,” Wilmington, Del.-based Incyte said in a statement. The company did not specify what more the FDA might need. Shares of the firm (NASDAQ:INCY) were trading midday at $68, down $4.26, or 5%.

Can’t resist? Beigene, Nurix ploys in BTK may dodge blood cancer problems

Phase II data that rolled out from Merck KGaA with its Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in relapsed multiple sclerosis put more eyeballs on the mechanism. It’s already well validated in oncology, but resistance has arisen there, and at least two firms – Beigene Ltd. and Nurix Therapeutics Inc. – are striving for solutions with degrader candidates. Darmstadt, Germany-based Merck updated the long-term efficacy and safety data Feb. 23 for evobrutinib that continue to show a favorable safety and tolerability profile, in line with findings unveiled earlier from the double-blind period of clinical experiments.

Bio-Europe Spring 2023: China’s appetite for more complex deals is growing

The increased availability of capital, greater access to talent, strong local governmental support and more focused attention on IP issues have increased the complexity of deals taking place between biotech and big pharma companies in China, according to Michelle Chan, chief business officer of Insilico Medicine Inc, who spoke in a panel discussion on the topic of Asia-Pacific partnering at this year’s Bio-Europe Spring, in Basel, Switzerland on March 21.

Stalicla secures CRADA on strong mavoglurant data for cocaine abuse

After Novartis AG decided not to take it forward in-house, the U.S. National Institute on Drug Abuse (NIDA) is to fund phase III development of mavoglurant in the treatment of cocaine abuse disorder. The agreement to back a trial involving up to 330 participants is with Stalicla SA, which in-licensed the glutamate receptor antagonist from Novartis earlier this year. Getting funding from NIDA is a “validation of mavoglurant’s potential in treating patients with substance abuse disorders,” said Lynn Durham, co-founder and CEO of Stalicla.

Partially blocking inflammatory receptor could lead to treatment for osteoarthritis

Partially blocking a receptor that helps regulate the activity of the inflammatory cytokine molecule interleukin-6 seems to promote tissue regeneration and block degeneration in a model of osteoarthritis. As reported in the March 22, 2023, issue of Science Translational Medicine, the receptor, called glycoprotein 130, regulates both positive and negative inflammatory responses that can help regenerate tissue, but also cause degeneration.

Also in the news

89bio, Abbvie, Advantage, Alkermes, Assembly, Astellas, Astrazeneca, Astrivax, Aurion, Bayer, Bioasis, Biogen, Bridgebio, Brii, Celyad, Cidara, Creative Medical Technology, Cyclerion, Dyne, Glaxosmithkline, Grin, Incyte, Inozyme, Kite, Marinus, Melinta, Mitsubishi Tanabe, Moleculin, Nexcella, Olix, Ono, Pragma, PTC, Regeneron, Sanofi, SQZ, Transcenta