GeneOnline’s Weekly News Highlights: Oct 22-Oct 27

GeneOnline’s editorial team has compiled a digest of top international biotechnology and healthcare news of the week to help readers keep abreast of global biomedical industry updates.

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The First and Only FDA-approved Drug for Chronic Digestive Diseases by Celltrion USA

The U.S. Food and Drug Administration (FDA) has granted approval to ZYMFENTRA™ (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following intravenous infliximab treatment. This marks a significant development in the field of healthcare, offering an innovative solution to address these chronic digestive diseases. Celltrion USA, the company behind this subcutaneous version of Celltrion’s infliximab biosimilar., submitted a Biologics License Application (BLA) under the 351(a) pathway of the Public Health Service Act, leading to the FDA’s approval based on pivotal data from Phase 3 studies. 

Mithra Submits Marketing Approval Application in Japan to Combat Dysmenorrhea

Mithra Pharmaceuticals, a Belgian biotech company dedicated to Women’s Health, announced a significant development in its partnership with Fuji Pharma Co., Ltd. on October 23 as they submitted a marketing approval application for ESTELLE® in Japan. This strategic move is part of a broader mission to address dysmenorrhea, a common women’s health issue. The global dysmenorrhea market, valued at €257 million (approximately $271 million) in 2022, reflects the pressing need for effective treatments. As Mithra takes significant steps in Japan, its mission to redefine women’s health gains momentum.

Singapore Health Tech Startup Mesh Bio Raises Funds to Tackle Chronic Diseases

Mesh Bio, a Singapore-based health tech start-up company, has recently successfully secured an undisclosed investment from East Ventures, a prominent venture capital firm in Southeast Asia. Mesh Bio specializes in developing digital solutions to enhance the management of chronic diseases through predictive analytics. The received funding is earmarked for advancing their digital twin technologies dedicated to chronic disease management. The company is strategically focused on expanding its services across Southeast Asian nations, with specific attention to Indonesia, Malaysia, and the Philippines.

Roche Acquires Roviant’s Antibody Drug for Treating Inflammatory Bowel Disease for $7.25 Billion

On October 23, Roche announced its entry into a definitive agreement with Roivant Sciences, a commercial-stage biopharmaceutical company, to acquire Telavant, a developer of a new treatment for inflammatory bowel diseases (IBD) owned by Roivant and Pfizer. The agreement includes the development, manufacturing and commercialization rights in the US and Japan for Telavant’s RVT-3101, a Phase 3-ready TL1A directed antibody as a promising new therapy for IBD, including ulcerative colitis and Crohn’s disease. As part of the agreement, Roche will pay an upfront purchase price of $7.1 billion and a near-term milestone payment of $150 million. The transaction is currently expected to close in Q4 2023 or in Q1 2024.

OrbiMed Raises $4.3 Billion Across Private Investment Funds

In the wake of a lengthy market downturn, OrbiMed announced on October 24 that it had raised over $4.3 billion by raising three new funds, OrbiMed Private Investments IX, OrbiMed Asia Partners V, and OrbiMed Royalty & Credit Opportunities IV, to invest in public and private biotech companies worldwide. The New York-based hedge fund is led by 21 partners and is one of the largest healthcare investors in the world, with an estimated $18 billion in assets under management. It targets innovative and growth-oriented opportunities in biopharmaceuticals, medical devices, diagnostics, and technology-enabled healthcare services across multiple healthcare segments.

Five Drugs and Vaccines Featured in Time’s Annual List of Best Inventions of 2023

Biogen, Eisai, GSK, Novo Nordisk, Provention Bio, Sage Therapeutics, and Sanofi were among the companies named to Time’s annual list of the best inventions of 2023 released on October 24. There were two Biogen products on this list, once with Eisai for the Alzheimer’s drug Leqembi, and another with Sage Therapeutics for the postpartum treatment Zurzuvae. A number of RSV prevention options were also lauded by the panel as major breakthroughs in the category, including GSK’s first RSV vaccine Arexvy, Pfizer’s Abrysvo for older adults and pregnant women, and Sanofi’s Beyfortus antibody for infants. Novo Nordisk’s semaglutide product portfolio of Ozempic, Wegovy and Rybelsus made the list as groundbreaking type 2 diabetes and obesity treatments. Sanofi and Provention Bio’s Tzield biologic approved to delay the onset of type 1 diabetes also made the list.

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GeneOnline Team