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Major Medical News in the U.S. Pharma Industry in August 2023: Breakthroughs in Treatment, New Drugs, Experimental Research

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The FDA has approved Sandoz's drug Tyruko (natalizumab), becoming the first biosimilar authorized in the U.S. for the treatment of multiple sclerosis, comparable to Biogen's "Tysabri" (natalizumab). Tyruko is intended for injections in adult patients with relapsing forms of multiple sclerosis, as stated on the Sandoz website.

Sandoz is a division of Novartis specializing in the production of non-patented medicines.

According to the company, nearly a million people in the U.S. suffer from multiple sclerosis, with hundreds of thousands experiencing disease relapses. Tyruko can expand the treatment options for natalizumab for such patients and "stimulate innovation through market competition," according to the announcement.

Multiple sclerosis is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system, which can significantly impact daily life. Most patients experience periods of new symptom onset or relapses that partially or completely improve and alternate with periods of remission.

American company Danaher, involved in the manufacturing and sale of medical and industrial products and services, will acquire all shares of the British company Abcam, specializing in the production of research consumables necessary for drug development. The deal is valued at $5.7 billion.

The agreement is part of Danaher's strategy to track complex diseases and accelerate drug development, and it is expected to close by mid-2024. Abcam will continue to operate as an independent company within Danaher's Life Sciences segment, specializing in biosciences.

"We are thrilled to welcome Abcam to Danaher. Their long-standing track record of innovation and outstanding product quality make Abcam a key partner for the scientific community," said Danaher President and CEO Rainer Blair.

In 2021, Danaher acquired Aldevron for $9.6 billion, a leading global manufacturer of high-quality plasmid DNA, mRNA, recombinant proteins used in vaccines, gene and cell therapy, enzymes, antibodies, and other bioproducts.

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AstraZeneca has stated that it is filing a lawsuit with the aim of protecting timely access to medicines in the United States. The U.S. government offers several incentives for the development of treatments targeting rare diseases as soon as they enter the market. However, AstraZeneca believes that the program will impede further development of such treatments, such as the cancer drug Lynparza and the rare blood disorders drug Soliris, which have orphan drug status for many conditions.

According to the U.S. government's plan, the first meeting regarding the reduction of prices for ten expensive drugs will take place next month. The agreed-upon prices will take effect in 2026. The list of candidate drugs compiled by analysts and pharmaceutical companies includes several dozen medications, including Jardiance from Boehringer and Eli Lilly (used to treat type 2 diabetes).

Pfizer and BioNTech have accused Moderna of copyright infringement and intend to seek the invalidation of Moderna's patents for mRNA vaccine technology against COVID-19. In 2022, Moderna developed therapeutic agents and vaccines based on mRNA, and based on this, it filed patent infringement lawsuits against Pfizer and BioNTech, accusing them of infringing its patent rights in the production of the COVID-19 vaccine.

Pfizer and BioNTech have informed the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office that the two patents held by Moderna, mentioned in the lawsuits, are "incredibly broad" and pertain to an "idea [of vaccines] that was known long before" their registration in 2015.

The Patent Trial and Appeal Board is reviewing the validity of patents based on the concept of "prior art," which describes technological solutions existing in the world that are similar to those proposed in a new patent. Pfizer and BioNTech claim that at the time of Moderna's patent registration, the technologies she presented already existed.

However, Moderna previously claimed that its patents were infringed. "Moderna believes that the Comirnaty COVID-19 vaccine developed by Pfizer and BioNTech infringes on patents filed by Moderna between 2010 and 2016 related to Moderna's core mRNA technology. This innovative technology was critical to Moderna's own mRNA COVID-19 vaccine – Spikevax. Pfizer and BioNTech copied this technology to create Comirnaty without Moderna's permission," the company stated.

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