Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Romvimza scoring FDA approval for treating Tenosynpvial Giant Cell Cancer, despite positive phase 3 results Bristol Myers having to cut off its allergy asset, Biogen securing $250 million in funding, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
FDA Approves Romvimza for Rare Joint Tumor, Offering New Treatment Option
The FDA has approved Romvimza (vimseltinib) for treating tenosynovial giant cell tumor (TGCT) in patients unsuitable for surgery. Developed by Ono Pharmaceuticals, Romvimza is a kinase inhibitor targeting the CSF1 receptor to prevent tumor growth. Phase III MOTION study results showed a 40% response rate and significant improvements in mobility and pain. Unlike its competitor Turalio, Romvimza has a more convenient dosing schedule and lacks a hepatotoxicity warning. Ono acquired Romvimza through its $2.4 billion purchase of Deciphera Pharmaceuticals and plans to launch it in the U.S. soon to address this rare but debilitating condition.
Bristol Myers Squibb Cuts Drug Programs to Boost Cost Savings
Bristol Myers Squibb (BMS) has intensified its cost-reduction strategy, discontinuing plans to commercialize cendakimab despite positive phase 3 results and halting the development of a TYK2 inhibitor. CEO Chris Boerner increased the company’s savings target by $2 billion, prioritizing high-return investments. The firm opted to focus on Sotyktu over its TYK2 successor and is accelerating multiple myeloma research with an adjusted phase 3 trial for iberdomide. BMS remains committed to strategic investments, emphasizing programs with strong competitive advantages while withdrawing from less promising opportunities to streamline its pipeline.
Biogen Secures $250M for Lupus Drug, Eyes Billion-Dollar Market
Biogen has secured $250 million from Royalty Pharma to fund phase 3 trials of litifilimab, an anti-BDCA2 antibody for systemic and cutaneous lupus erythematosus (SLE/CLE). With few treatment options available, Biogen sees litifilimab as a major opportunity in an underserved market. The company opted for external funding to focus on other pipeline assets, including additional lupus treatments. Under CEO Christopher Viehbacher, Biogen has prioritized cost management, cutting R&D spending by 17% last year. If successful, litifilimab could contribute to Biogen’s projected $9-$14 billion peak sales, with regulatory submissions expected between 2027 and 2029.
Former Inizio Evoke Executives Launch Flex Marketing for Health Industry
A team of former Inizio Evoke executives has launched Flex Marketing, an independent agency specializing in pharmaceutical, biotech, medtech, and health tech marketing. Based in San Francisco, Flex offers market research, strategic planning, brand development, and data-driven analytics with a focus on adaptability. The agency is led by four partners: Gelling (client engagement), Amber Rogers (brand strategy), Jason Luis (omnichannel strategy), and Michelle Green (creative). With extensive industry experience, the team aims to provide tailored marketing solutions to global clients while maintaining independence and agility in a rapidly evolving healthcare landscape.
FDA Approves Penmenvy, First Meningococcal ABCWY Vaccine for Ages 10-25
The FDA has approved Penmenvy, a vaccine targeting meningococcal groups A, B, C, W, and Y, for individuals aged 10 to 25. Developed by GSK, Penmenvy combines elements from Bexsero and Menveo to enhance protection against invasive meningococcal disease. Approval was based on two phase 3 trials involving over 4,800 participants, demonstrating strong immune responses and safety. With meningococcal cases rising since 2021, the CDC’s Advisory Committee on Immunization Practices will soon vote on usage recommendations. Penmenvy’s approval marks a significant advancement in broad-spectrum meningococcal disease prevention.
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