Sandoz Group AG

Novo Holdings completes $16.5B Catalent Pharma Solutions buyout. Merck pays $112M upfront for obesity pill. Ottimo Pharma raises $140M for cancer therapy. Novo Nordisk invests $1.2B in Denmark factory. Angitia Biopharmaceuticals raises $120M for musculoskeletal candidates. Novartis closes MorphoSys sites, laying off 330. SiteOne Therapeutics secures $100M for non-opioid pain drugs. Novo Nordisk's obesity drug underperforms. Bristol Myers Squibb invests $100M in BioArctic's Alzheimer antibodies. Sudan's healthcare collapses. Tonix Pharmaceuticals files NDA for fibromyalgia drug. Neurocrine Biosciences wins FDA approval for Crenessity. Edgewise Therapeutics discusses accelerated approval for Becker muscular dystrophy. FDA places partial hold on PepGen's Duchenne therapy. Checkpoint Therapeutics' immunotherapy approved. WHO opens Academy in Lyon. GSK's Jemperli earns FDA Breakthrough status. Sanofi's duvakitug shows remission in ulcerative colitis. Sandoz agrees to $275M settlement over drug pricing. Pfizer projects 2025 earnings. Mesoblast's Ryoncil approved as 1st MSC therapy for graft-vs-host disease.

FDA accepted Tonix's NDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia, with a PDUFA target action date expected. TNX-102 SL, granted Fast Track designation, could be the first new fibromyalgia drug in over 15 years, supported by two Phase 3 studies showing significant pain reduction and good tolerability.

The EMA CHMP gave positive opinions for Celltrion's three biosimilars, including Eydenzelt (biosimilar aflibercept), Stoboclo and Osenvelt (biosimilar denosumab), and Avtozma (biosimilar tocilizumab). The European Commission will decide on marketing authorisations. Eydenzelt is recommended for treating multiple retinal disorders and met equivalence criteria in a Phase III study. Celltrion's Taehun Ha emphasized the company's commitment to affordable, high-quality treatments in Europe.

Axsome Therapeutics, a $4.37B biopharma company, focuses on CNS disorders, with AUVELITY for MDD driving $104.8M Q3 2024 revenue. The pipeline includes AXS-05 for ADA and AXS-07 for migraine, with strong IP protection and analyst optimism.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

Law Offices of Gary Martin Hays & Associates, P.C. contact: (470) 294-1674. Law Offices of Mark E. Salomone contact: (857) 444-6468.

Sandoz Group AG plans to launch a generic Ozempic in Canada by 2026, betting on sustained demand for current GLP-1 weight-loss drugs despite new contenders. The company aims to produce a reliable generic version of semaglutide, the active ingredient in Ozempic, targeting Canada's large obesity market. Sandoz CEO Richard Saynor believes generics could significantly expand patient access if prices drop.

The USPTO withdrew a proposed rule to add a new requirement for terminal disclaimers to overcome non-statutory double patenting, favoring big pharma over biosimilar developers. The decision was based on 349 comments, with big pharma's outweighing those favoring the change.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but with stricter controls. Biosimilars, including Humira’s, have struggled with adoption despite cost savings potential. Optum Rx also adds and removes various oncology and CNS medications for 2025.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but is subject to prior authorization. Biosimilars have struggled with low adoption despite cost advantages, but large PBMs like CVS Health are shifting towards biosimilars. Optum Rx also adds and removes various oncology and CNS medications from its 2025 formulary.