The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that has plenty of competition. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis (gMG) in patients who are 12 years and older. There are approved gMG therapies on the market from Argenx SE, UCB SA and Astrazeneca plc. Imaavy’s approval was based on results from the pivotal phase III Vivacity study of adults with gMG. Data showed a statistically significant reduction in a daily activity score from baseline over weeks 22 to 24 compared with placebo. The study was a randomized, double-blind clinical trial in adults with moderate to severe gMG with insufficient response to standard-of-care therapies.

Novartis adds further to renal disease pipeline via $1.7 Regulus buy

Regulus Therapeutics Inc. is being acquired by Novartis AG in a potential $1.7 billion deal focused primarily on lead candidate farabursen, an oligonucleotide targeting autosomal dominant polycystic kidney disease set to start phase III testing on a path to a potential accelerated approval. Terms include about $800 million at closing to acquire the outstanding stock at $7 per share, marking a 274% premium to Regulus’ 60-day volume-weighted average stock price and a 108% premium to the April 29 closing price of $3.37. The rest of the payment is tied to a contingent value right linked to regulatory approval of farabursen.

Hearing: 2026 US NIH budget important, but stability needed now

If today’s hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could be facing a big challenge in trying to cut more than 40% of the NIH’s budget in fiscal 2026. But the real urgency is much more immediate, according to the experts testifying at the hearing. “The scientific community is in paralysis right now. It is in paralysis across the country – in every state,” said Sudip Parikh, executive publisher of Science and CEO of the American Association for the Advancement of Science. “There are graduate students, scientists and senior scientists who instead of thinking about the very problems you’re talking about, are thinking about the next grant. They’re thinking about the next six weeks.” The need right now, he added, is stability.

AACR 2025: D3 Bio, Immvira present solid tumor, brain cancer data

Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine. Suzhou, China-based Immvira Co. Ltd. also presented phase I clinical results of MVR-C5252, a genetically engineered oncolytic HSV-1 virus that produces IL-12 and anti-PD-1 antibodies developed on the company's Ovpens platform for intratumoral treatment of recurrent or progressive glioma.

South Korea approves record number of biosimilars in 2024

South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012. 2024 was also a banner year for U.S. FDA biosimilar approvals, as the U.S. agency cleared a total of 18 products last year, pushing the total to 63 biosimilars on the U.S. market to date. The EMA in 2024 recommended a total of 28 biosimilars, among 114 new drug approvals. South Korea has cleared a total of 72 biosimilars to date, of which 52 were from domestic developers such as Incheon-based Celltrion and Samsung Bioepis Co. Ltd.

100 days of uncertainty

Massive terminations. Axed programs. Canceled grants and contracts. Communication freezes. Threats and more threats of tariffs. Lawsuit upon lawsuit. Policy whiplash. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe.

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