Weekly Rundown: First malaria drug for babies approved

Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.

First malaria drug for babies approved

On July 8th, Novartis announced that they received approval in Switzerland for the first-ever drug to treat malaria in newborns and infants. The drug, known as Coartem Baby, is a novel formulation of the adult drug Coartem, which comes in tablets. The approval marks a major step forward, addressing a critical treatment gap for newborns and infants — a group that accounts for 76 percent of malaria deaths, or more than 1,000 young lives lost each day. The newborn version was developed as a collaboration between Novartis and Medicines for Malaria Venture (MMV), with a new dosage and the capability to dissolve in liquid (including breast milk). Switzerland’s approval was based on the Phase 2/3 CALINA study, and Novartis reported that they now expect rapid approvals in eight African countries. In the press release, Martin Fitchet, Chief Executive Officer (CEO) of MMV said, “The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.” – Allison Whitten

New CRISPR center aims to bring gene therapy to children with rare diseases

A new Center for Pediatric CRISPR Cures at the University of California, San Francisco is launching with an ambitious goal: to deliver customized gene-editing treatments to children battling rare genetic diseases. Backed by $20 million from the Chan Zuckerberg Initiative, the center is a collaboration between Nobel laureate biochemist at the University of California, Berkeley Jennifer Doudna and cofounder and co-Chief Executive Officer (co-CEO) of the Chan Zuckerberg Initiative Priscilla Chan. Inspired by the successful treatment of baby KJ Muldoon — who received a personalized CRISPR therapy that corrected a metabolic disorder — the center will begin clinical trials with eight children. “We want to ensure that CRISPR-based therapies become widely available, especially for rare diseases that likely won't be the target for pharmaceutical companies," Doudna told TIME. – Bree Foster

Trump threatens 200 percent tariffs on foreign-made drugs

President Donald Trump has intensified his pressure on the pharmaceutical industry, threatening to impose tariffs as high as 200 percent on drugs manufactured outside the US. The announcement, made during a Cabinet meeting, marks a sharp escalation from his earlier 25 percent tariff proposal and is part of a broader push to encourage domestic drug production. Despite the aggressive rhetoric, markets remained stable and pharma stocks were largely unaffected. The move follows a Section 232 investigation into the national security risks of pharmaceutical imports, with Commerce Secretary Howard Lutnick indicating that tariff details could be finalized by the end of the month. Trump, however, noted that companies would be given a year or more to shift manufacturing back to the US before any tariffs take effect. While some drugmakers have announced US investments, industry leaders warn that such tariffs could disrupt global supply chains and impact patient care. – Bree Foster

FDA clears blood pressure band and approves rare disease drug

The Hilo Band, a cuffless 24/7 blood pressure monitor developed by Aktiia, received FDA clearance. The device becomes the first cuffless blood pressure monitor approved for over-the-counter use in the US, though Aktiia notes the product won’t be available in the US until 2026.
After a delay, the FDA approved KalVista’s oral drug Ekterly to treat the rare swelling disease hereditary angioedema (HAE). The approval follows the FDA’s recent approval of CSL’s subcutaneous injection to treat HAE. – Allison Whitten

Centivax raises $45 million to advance universal flu vaccine to human trials

Centivax, a South San Francisco biotech startup, has raised $45 million in Series A funding to launch human trials within eight months for what it says could be the first universal flu vaccine — one designed to train the immune system to target only the unchanging regions of the virus. This is important because a universal flu vaccine, if successful, could eliminate the need for annual shots and provide broad, lasting protection against evolving strains. Founded in 2019, Centivax has also secured $24 million in grants from groups like the Gates Foundation and NIH, and is applying its epitope-targeting platform to other high-need areas including respiratory syncytial virus (RSV), human immunodeficiency virus (HIV), malaria, and even snake venom. As part of its next phase, the company has added Emilio Emini, a veteran of Pfizer, Merck, and the Gates Medical Research Institute, to its board. “Centivax’s approach to universal immunity is unique and creative,” Emini told TechStartups. “It has considerable potential for achieving what’s eluded the field for decades.” – Bree Foster

Researchers find a way to prevent type 1 diabetes caused by immunotherapy

Immune checkpoint inhibitors (ICIs) are effective cancer treatments, but in rare cases — about 1 percent of patients — they can trigger a life-threatening form of type 1 diabetes (1). Now, scientists at the University of California, Los Angeles discovered a new approach to prevent or possibly reverse the disease by targeting CD4+ T follicular helper cells, which they found played a significant role in the autoimmune attack on insulin-producing pancreatic cells (2). In a mouse model, the team also showed that the use of Janus kinase (JAK) inhibitors prevented the onset of ICI-induced type 1 diabetes. In a press release, endocrinologist and coauthor Melissa Lechner said, “This study brings us closer to protecting patients without compromising the life-saving benefits of their treatment.” – Allison Whitten

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