Breaking News

Novartis wins approval for newborn malaria treatment

July 8, 2025
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National Biotech Reporter
Good morning, I hope everyone had a great holiday weekend. Let's get into the news today.

The need-to-know this morning

  • Foundering CAR-T therapy developer Cargo Therapeutics is being acquired and shut down. The buyer is Concentra Biosciences, the private company run by investor Kevin Tang.

Global health

Novartis wins approval for newborn malaria treatment

From my colleague Andrew Joseph: Novartis said today that Swiss regulators have approved its malaria medicine Coartem for newborns and young infants, extending a long-standing treatment to the smallest babies.

Eight sub-Saharan African nations participated in the Swiss regulatory process through a program the country has to help speed access to treatments in low-income parts of the world, and it's expected those countries — Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda — will issue their own approvals soon. Novartis said it plans to make the drug, which for the youngest patients will be known as Coartem Baby or Riamet Baby, available by the end of the year "on a largely not-for-profit basis."

Coartem has long been approved for older babies, but clinicians have lacked a treatment specifically designed for patients weighing less than 4.5 kilograms, or just under 10 pounds. Novartis, which worked on Coartem Baby with the Medicines for Malaria Venture, tweaked the ratio of the ingredients in Coartem and the dose to develop the new version of the drug, accounting for how newborns metabolize drugs differently than older babies. Coartem Baby can be dissolved in breast milk.



politics

Medical groups sue RFK Jr. over vaccine changes

Six major medical groups and a pregnant doctor are suing health secretary Robert F. Kennedy Jr. over changes he made to Covid-19 vaccine recommendations.

The suit, led by the American Academy of Pediatrics, centers around a May directive by Kennedy, which said that the vaccines would no longer be recommended for healthy children and pregnant people. The groups argue that this action violated decades of policy governing how vaccines are approved and recommended in the U.S.

The directive puts doctors "in the untenable position of telling their patients that the country's top-ranking government health official's advice and recommendations are wrong and that we are right. This erodes trust," the suit reads.

Read more from STAT's Chelsea Cirruzzo.


gene therapy

Beam buys a mystery startup

From my colleague Jason Mast: Beam Therapeutics, the gene-editing company, has bought a private startup for just under $7 million in stock, plus another $89 million in potential milestone payments. That deal would hardly be notable except, in an unusual move, Beam opted not to name the company it acquired, referring to it only as an "early stage life sciences company" in SEC filings.

It's one of the only acquisitions Beam has made in the eight years since it launched to develop a new form of gene editing to change individual letters of DNA. The only other buyout of note was Guide Therapeutics, a delivery company it purchased for $120 million in stock in 2021, when a gene-editing boom sent its share price soaring. That buyout has seemingly yielded little for the company.

The gene-editing field, which has been struggling financially for the last two years, is currently trying to tackle two major bottlenecks: developing new delivery vehicles to edit specific, hard-to-reach cell types and developing new gene editors capable of making larger changes to the genome. What Beam's new acquisition focused on is anyone's guess. A spokesperson for the company declined to comment.


immunology

Cogent's immune drug worked, but it's difficult to size up

Cogent Biosciences reported yesterday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. Its drug, called bezuclastinib, led to a nine-point greater difference in a score of patients' symptoms compared with placebo.

But patients in Cogent's study had more severe disease at baseline than those in Blueprint's study. That difference that could have provided bezuclastinib a boost and makes comparisons between the two drugs more difficult.

Nevertheless, investors were encouraged by the data, sending Cogent's stock up over 20% yesterday.

Read more from STAT's Adam Feuerstein.


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Thanks for reading! Until tomorrow,


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