Copycat Ozempic makers just lost a big court fight
A federal judge in Texas handed Novo Nordisk (NVO) a big win late Thursday in its battle against cheaper versions of its blockbuster drugs Ozempic and Wegovy, rejecting a bid by compounding pharmacies to keep making the drugs while a legal challenge moves forward.
In a sealed order U.S. Judge Mark Pittman denied a request for preliminary injunction a trade group representing compounding pharmacies that would have prevented the Food and Drug Administration from taking action against its members for making knock-off versions using semaglutide, the active ingredient in the weight loss drugs.
Small-scale compounders must now immediately stop making their versions of Ozempic and Wegovy. Larger, federally licensed compounders have until May 22 to keep producing the copycats.
The popular drugs had been in short supply for some two years, which led the FDA to declare a shortage, thus allowing pharmacists to legally make compounded versions of the patented medications. Many telehealth companies also jumped into the market with compounded drugs. However, in February the FDA determined that the semaglutide shortage was over, leading to the lawsuit by Outsourcing Facilities Association.
'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy® and Ozempic® is resolved,' said Steve Benz, Corporate Vice President, Legal and U.S. General Counsel, Novo Nordisk in an statement. He said that the company will continue driving legal actions forward 'and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.'
Compounding pharmacies make drugs tailored to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.
Eli Lilly (LLY) has also taken aggressive legal action against compounding pharmacies, and on Wednesday filed lawsuits against four telehealth companies that offer cheaper versions of its weight loss drugs Mounjaro and Zepbound.
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For more information about the FORTITUDE trial, visit the FORTITUDE study website or visit and search for NCT05747924. For more information on the FORTITUDE-OLE study click here or visit and search for NCT06547216. About Del-brax Del-brax is designed to treat the underlying cause of FSHD, which is caused by the abnormal expression of a gene called double homeobox 4 or DUX4. The abnormal expression of DUX4 protein leads to changes in gene expression in muscle cells that are associated with the life-long, progressive loss of muscle function in patients with FSHD. Del-brax aims to reduce the expression of DUX4 mRNA and DUX4 protein in muscles in people with FSHD. Del-brax consists of a proprietary monoclonal antibody that binds to the transferrin receptor 1 (TfR1) conjugated with a siRNA targeting DUX4 mRNA. Del-brax is currently in registrational-stage studies including FORTITUDE biomarker cohort and the global, confirmatory, Phase 3 FORWARD trial in individuals with FSHD. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan designation for del-brax and the FDA has granted del-brax Fast Track designation. About Facioscapulohumeral Muscular Dystrophy (FSHD)Facioscapulohumeral muscular dystrophy (FSHD) is a rare, progressive, and variable hereditary muscle-weakening condition marked by life-long, relentless loss of muscle function, significant pain, fatigue, and progressive disability. It is characterized by progressive and often asymmetric skeletal muscle loss that initially causes weakness in muscles in the face, shoulders, arms and trunk and progresses to weakness in muscles in the lower body. FSHD is an autosomal dominant disease caused by the aberrant expression of the DUX4 (double homeobox 4) gene in the skeletal muscle, which activates genes that are toxic to muscle cells and leads to a series of downstream events that result in skeletal muscle wasting and compromised muscle function. 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These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Avidity's plans to file a BLA for accelerated approval of del-brax and the timing thereof; the potential for del-brax to achieve accelerated approval from the FDA; the status of accelerated approval as a regulatory pathway for del-brax; the use of KHDC1L as the primary endpoint in the FORTITUDE™ biomarker cohort; topline data from the biomarker cohort of the FORTITUDE trial and the timing thereof; characterization of data from the FORTITUDE trial; the potential for del-brax to improve the lives of people with FSHD; the status of the FORTITUDE trial and the cohorts therein and the FORWARD™ trial, including without limitation progress, initiation, enrollment, design, goals and dosage levels and frequencies. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Avidity's business and beyond its control, including, without limitation: the data and results produced from the FORTITUDE trial as of the most recent cutoff dates may not be indicative of final results, may not support BLA submission or accelerated approval, may not be satisfactory to the FDA and other regulators, and new analyses of existing data and results may produce different conclusions than established as of the date hereof; data delivered to the FDA may not support accelerated approval pathways or BLA submissions and may not be satisfactory to the FDA, including as a result of our inability to establish that a novel biomarker may serve as a surrogate endpoint reasonably likely to predict a clinical benefit; even if approved, Avidity may not be able to execute any successful product launches; unexpected adverse side effects to, or inadequate efficacy of, del-brax that may delay or limit its development, regulatory approval and/or commercialization; later developments with the FDA and other global regulators that could be inconsistent with the feedback received to date; Avidity's approach to the discovery and development of product candidates based on its AOC™ platform is unproven and may not produce any products of commercial value; potential delays in the commencement, enrollment, data readouts and completion of clinical trials; Avidity's dependence on third parties in connection with clinical testing and product manufacturing; legislative, judicial and regulatory developments in the United States and foreign countries; Avidity could exhaust its available capital resources sooner than it currently expects; and other risks described in Avidity's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and subsequent filings with the SEC. 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Abcuro Appoints Courtney Cupples as Chief Commercial Officer
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