• Coartem^® (artemether-lumefantrine) Baby becomes first malaria treatment approved for newborn babies and young infants

• Rapid approvals in eight African countries now expected under a special global health scheme run by Swiss agency for therapeutic products (Swissmedic)

• Novartis plans to introduce infant-friendly Coartem Baby on largely not-for-profit basis to increase access in areas where malaria is endemic

Basel, July 8, 2025 – Novartis today announced Coartem^® (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants. The new treatment, also known as Riamet^® Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) to treat the potentially deadly mosquito-borne disease.

Eight African countries also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency’s Marketing Authorization for Global Health Products procedure.¹ Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic.

“For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most,” said Vas Narasimhan, CEO of Novartis. “Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”

Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap. They have instead been treated with formulations intended for use in older children, which may increase the risk of overdose and toxicity. Malaria vaccines are also not approved for the youngest babies.²

Some 30 million babies are born in areas of malaria risk in Africa every year,³ with one large survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than 6 months old.⁴ However, current data on malaria in young babies is extremely limited as they are rarely included in clinical trials of antimalarial agents.^5,6

“The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials,” said Professor Umberto D’Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. “That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.”

The new dose strength designed for young infants was developed by Novartis with the scientific and financial support of MMV, and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer. 

“Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,” said Martin Fitchet, CEO of MMV. “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.”

About the CALINA study
The Swissmedic approval is based on the Phase II/III CALINA study, which investigated a new ratio and dose of Coartem (artemether-lumefantrine) to account for metabolic differences in babies under 5 kilograms. It is indicated for the treatment of infants and neonates weighing between 2 and less than 5 kilograms with acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum. Coartem is known by the brand name Riamet in Switzerland and some other countries.

About malaria
Malaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.⁷

About Novartis in malaria innovation
Novartis finds breakthroughs for diseases neglected by science and brings innovative medicines to communities on the margins of healthcare, building on 85 years of innovation in global health. Novartis has built the industry’s largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases, backed by nearly USD 490 million in funding for global health R&D since 2021. This includes four new antimalarial compounds with the potential to combat rising drug resistance, one of which is just completing Phase III trials, and another which is a potential single-dose cure. Since 1999, Novartis has delivered more than 1.1 billion treatment courses of antimalarials, mostly at no profit, including 500 million treatments of a child-friendly formulation for babies weighing at least 5 kilograms.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

About MMV
MMV is a Swiss not-for-profit working to deliver a portfolio of accessible medicines with the power to treat, prevent and eliminate malaria. Born in 1999 to drive health equity, MMV closes critical gaps in research, development and access – to expand the use of existing antimalarials and innovate new compounds. This starts with women and children. As of 2024, MMV-supported products have effectively treated more than 711 million patients.

For more information, visit www.mmv.org Follow MMV on social media: X, LinkedIn, YouTube and Facebook 

References

1. Eight African countries participated in Swissmedic’s Marketing Authorization for Global Health Products (MAGHP) procedure for Coartem Baby – Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda — and are expected to approve the medicine following approval by Swissmedic. These eight countries account for 47% of estimated cases in 2023, according to the WHO’s Global Health Observatory
2. WHO. Malaria vaccines (RTS,S and R21)
3. Reddy, Valentina et al. Global estimates of the number of pregnancies at risk of malaria from 2007 to 2020: a demographic study. The Lancet Global Health, Volume 11, Issue 1, e40 – e47
4. Ceesay SJ et al. Malaria Prevalence among Young Infants in Different Transmission Settings, Africa. Emerg Infect Dis. 2015 Jul;21(7):1114-21. doi: 10.3201/eid2107.142036. PMID: 26079062; PMCID: PMC4480393.
5. D’Alessandro U, et al. Malaria in infants aged less than six months – is it an area of unmet medical need? Malar J. 2012 Dec 2;11:400. doi: 10.1186/1475-2875-11-400. PMID: 23198986; PMCID: PMC3529680.
6. Dobbs, et al. Plasmodium malaria and antimalarial antibodies in the first year of life. Parasitology. 2016;143(2):129-138. doi:10.1017/S0031182015001626
7. WHO. Malaria.

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CNN
 — 

President Donald Trump sent letters to the leaders of seven more countries Wednesday, adding to the growing list of US trading partners for whom he has threatened new tariff rates.

Among the latest recipients were the Philippines, Sri Lanka, Moldova, Brunei, Algeria, Libya and Iraq, with rates going as high as 30% on goods they ship to the United States. The new tariffs go into effect August 1, pending negotiations.

Trump said Wednesday afternoon that he planned to announce his tariff level for Brazil within the next day or two. “Brazil as an example, has been not good to us. Not good at all,” he said during a White House multilateral meeting with leaders of African nations. “We’re going to be releasing a Brazil number, I think, later on, this afternoon or tomorrow morning.”

The rates Trump said would be imposed on goods from Sri Lanka, Moldova, Iraq and Libya were lower than those he announced in early April. The rates on goods from the Philippines and Brunei were higher, compared to April levels. Meanwhile, the rate on goods from Algeria was the same (30%) as April levels.

Collectively, the US imported $29 billion worth of goods from those seven nations last year, according to US Commerce Department figures. That accounts for less than 1% of the $3.2 trillion of goods the US imported.

US stocks were mostly unchanged after Trump’s posts. The Dow was up 50 points, or 0.11%. The S&P 500 was up 0.25% and the tech-heavy Nasdaq gained 0.58%.

The US and various trading partners have been negotiating new trade agreements since Trump announced so-called “reciprocal” tariffs back in April. Yet few deals have come to fruition.

During a cabinet meeting on Tuesday, Trump said “a letter means a deal.” But that doesn’t appear to be how some countries are perceiving the missives.

In the letters, Trump wrote that he takes particular issue with the trade deficits the United States runs with other nations, meaning America buys more goods from there compared to how much American businesses export to those countries. Trump also said the tariffs would be set in response to other policies that he deems are impeding American goods from being sold abroad.

Trump has encouraged world leaders to manufacture goods in the United States to avoid tariffs. If they chose to retaliate by slapping higher tariffs on American goods, Trump threatened to tack that onto the rate charged on their country’s goods shipped to the United States.

Trump has now sent 21 letters on tariff rates to heads of state this week, and more could still come. The 25% tariff Trump threatened to impose on Japan and South Korea would be most likely to impact prices of goods Americans buy, since the two nations are America’s fifth- and seventh-top sources of foreign goods.

Wednesday at 12:01 a.m. ET was the initial deadline Trump set three months ago for countries to ink trade deals with the US or instantly face higher tariff rates. However, on Monday he extended that deadline to August 1.

This is a developing story. It will be updated.

New York
CNN
 — 

Linda Yaccarino is stepping down as CEO of X after two years leading Elon Musk’s social media company.

Yaccarino’s departure comes one day after the company’s Grok chatbot began pushing antisemitic tropes in responses to users. It’s not clear that the events were connected.

Her exit also comes months after Musk sold X, his social media company, to xAI, his artificial intelligence company. The move formally combined the two entities that were already closely intertwined, but raised questions about Yaccarino’s role in the new company going forward.

Yaccarino announced her exit in a post on the platform, saying she is “immensely grateful” to Musk for “entrusting me with the responsibility of protecting free speech, turning the company around, and transforming X into the Everything App.”

“Now, the best is yet to come as X enters a new chapter with @xai,” she said in the post. “I’ll be cheering you all on as you continue to change the world.”

Musk replied to Yaccarino’s post with a terse response: “Thank you for your contributions.”

Yaccarino, a former NBCUniversal marketing executive, took over from Musk as CEO of X — at the time, it was called Twitter — in June of 2023, about eight months after the billionaire bought the social media platform. She was brought on to help fix the platform’s flagging advertising business, after Musk alienated brands with his controversial comments and changes to the platform.

But her tenure has been marked by repeated public relations crises, including scrutiny over antisemitic and other hateful content spreading on the platform, viral false claims around international conflicts and ads that appeared alongside pro-Nazi content on the site. That led some brands to pull their spending, for which the Yaccarino-led X sued an advertising industry group — a lawsuit Yaccarino announced in a video message to all X users, in which she decried what she referred to as a conspiracy to boycott the X platform. (The industry group, Global Alliance for Responsible Media, shut down days after the lawsuit was filed.)

In the years since Musk took over X, the company has also had to contend with a rush of new competitors, including Bluesky and Meta’s Threads.

Yaccarino repeatedly touted the company’s “freedom of speech, not freedom of reach” policy that aims to limit the reach of so-called lawful but awful content on the platform. Under her leadership, X also said it had rolled out additional brand safety controls for advertisers, including the ability to avoid having their ads show next to “targeted hate speech, sexual content, gratuitous gore, excessive profanity, obscenity, spam, drugs.”

But the company’s challenges escalated after X integrated xAI’s Grok chatbot into the platform, where users can ask the AI questions and bring it into conversation threads with other users. In May, Grok erroneously brought up a theory of “white genocide” in South Africa in response to unrelated questions. And on Tuesday — weeks after Musk said he would rebuild the chatbot because he was unsatisfied with some of its replies that he viewed as too politically correct — the chatbot shared antisemitic tropes. In response, xAI said it removed some posts and “has taken action to ban hate speech before Grok posts on X.”

It’s not clear whether Yaccarino, as head of the social media business, had any control over Grok or the company’s other AI operations.

During her time as CEO of X, Yaccarino also faced questions about her power and influence over the company compared to Musk. The billionaire has said he is the company’s chief technology officer, leading product and technology teams, but his controversial statements and seemingly off-the-cuff policy pronouncements often seemed to leave Yaccarino on the back foot.

“Being the CEO of X was always going to be a tough job, and Yaccarino lasted in the role longer than many expected,” Jasmine Enberg, vice president at research firm Emarketer, said in emailed commentary. “Faced with a mercurial owner who never fully stepped away from the helm and continued to use the platform as his personal megaphone, Yaccarino had to try to run the business while also regularly putting out fires.”

And while X announced on-platform video podcasts with high-profile figures like Khloe Kardashian and several new finance tools, including a partnership with Visa to provide peer-to-peer payments, those features are niche offerings and the platform has not exactly become the “everything app” Yaccarino said she wanted to create.

Use of the platform has also fallen during her tenure, from 915.9 million combined active app users and unique website visitors during the month she took over to just 684.2 million last month, according to web traffic analysis firm Similarweb.

Yaccarino’s exit comes at a complicated time for Musk’s businesses, especially Tesla, and his political involvement has raised questions about his ability and commitment to lead multiple companies. Her departure comes shortly after several high level exits at Tesla, including Omead Afshar, Tesla’s head of manufacturing and operations.

Musk has also recently engaged in a high-profile feud with President Donald Trump, whom he’d previously supported, that has created a rift between Musk-world and Trump-world and prompted threats from the White House against the billionaire’s companies.

This story has been updated with additional details and context.

CNN’s Hadas Gold contributed to this report.