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Novartis receives approval for first malaria medicine for newborn babies and young infants
- 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
- 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
- WHO. Malaria vaccines (RTS,S and R21)
- 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
- 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.
- 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.
- Dobbs, et al. Plasmodium malaria and antimalarial antibodies in the first year of life. Parasitology. 2016;143(2):129-138. doi:10.1017/S0031182015001626
- WHO. Malaria.
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Trump tariffs goods from Brazil at 50%, citing ‘witch hunt’ trial against Bolsonaro
WASHINGTON (AP) — President Donald Trump singled out Brazil for import taxes of 50% on Wednesday for its treatment of its former president, Jair Bolsonaro, showing that personal grudges rather than simple economics are a driving force in the U.S. leader’s use of tariffs.
Trump avoided his standard form letter with Brazil, specifically tying his tariffs to the trial of Bolsonaro, who is charged with trying to overturn his 2022 election loss. Trump has described Bolsonaro as a friend and hosted the former Brazilian president at his Mar-a-Lago resort when both were in power in 2020.
“This Trial should not be taking place,” Trump wrote in the letter posted on Truth Social. “It is a Witch Hunt that should end IMMEDIATELY!”
There is a sense of kinship as Trump was indicted in 2023 for his efforts to overturn the results of the 2020 U.S. presidential election. The U.S. president addressed his tariff letter to Brazilian President Luiz Inacio Lula da Silva, who bested Bolsonaro in 2022.
Bolsonaro testified before the country’s Supreme Court in June over the alleged plot to remain in power after his 2022 election loss. Judges will hear from 26 other defendants in the coming months. A decision could come as early as September, legal analysts say. Bolsonaro has already been barred from from running for office until 2030 by the country’s electoral authorities.
Brazil’s vice president, Geraldo Alckmin, said he sees “no reason” for the U.S. to hike tariffs on the South American nation.
“I think he has been misinformed,” he said. “President Lula was jailed for almost two years. No one questioned the judiciary. No one questioned what the country had done. This is a matter for our judiciary branch.”
For Trump, the tariffs are personal
Trump also objected to Brazil’s Supreme Court fining of social media companies, saying the temporary blocking last year amounted to “SECRET and UNLAWFUL Censorship Orders.” Trump said he is launching an investigation as a result under Section 301 of the Trade Act of 1974, which applies to countries with trade practices that are deemed unfair to U.S. companies.
Among the companies the Supreme Court fined was X, which was not mentioned specifically in Trump’s letter. X is owned by Elon Musk, Trump’s multibillionaire backer in the 2024 election whose time leading Trump’s Department of Government Efficiency recently ended and led to a public feud over the U.S. president’s deficit-increasing budget plan. Trump also owns a social media company, Truth Social.
Brazilian lawmakers allied with President Lula blamed Bolsonaro and two of his sons, congressman Eduardo Bolsonaro and Sen. Flávio Bolsonaro, for Trump’s action.
“Every justification to retaliate against Brazil is political, as if Bolsonaro was politically persecuted,” Sen. Lindbergh Farias, the whip of Lula’s Workers’ Party in the Senate, said on social media. The Bolsonaros “must be very happy to harm Brazil, our economy and our jobs.”
The Brazil letter was a reminder that politics and personal relations with Trump matter just as much as any economic fundamentals. And while Trump has said the high tariff rates he’s setting are based on trade imbalances, it was unclear by his Wednesday actions how the countries being targeted would help to reindustrialize America.
The tariffs starting Aug. 1 would be a dramatic increase from the 10% rate that Trump levied on Brazil as part of his April 2 “Liberation Day” announcement. In addition to oil, Brazil sells orange juice, coffee, iron and steel to the U.S., among other products. The U.S. ran a $6.8 billion trade surplus with Brazil last year, according to the Census Bureau.
Trump initially announced his broad tariffs by declaring an economic emergency, arguing under a 1977 law that the U.S. was at risk because of persistent trade imbalances. But that rationale becomes problematic in this particular case, as Trump is linking his tariffs to the Bolsonaro trial and the U.S. exports more to Brazil than it imports.
Trump also targeted smaller trade partners
Trump also sent letters Wednesday to the leaders of seven other nations. None of them — the Philippines, Brunei, Moldova, Algeria, Libya, Iraq and Sri Lanka — is a major industrial rival to the United States.
Most economic analyses say the tariffs will worsen inflationary pressures and subtract from economic growth, but Trump has used the taxes as a way to assert the diplomatic and financial power of the U.S. on both rivals and allies. His administration is promising that the taxes on imports will lower trade imbalances, offset some of the cost of the tax cuts he signed into law on Friday and cause factory jobs to return to the United States.
Trump, during a White House meeting with African leaders, talked up trade as a diplomatic tool. Trade, he said, “seems to be a foundation” for him to settle disputes between India and Pakistan, as well as Kosovo and Serbia.
“You guys are going to fight, we’re not going to trade,” Trump said. “And we seem to be quite successful in doing that.”
Trump said the tariff rates in his letters were based on “common sense” and trade imbalances, even though the Brazil letter indicated otherwise. Trump suggested he had not thought of penalizing the countries whose leaders were meeting with him in the Oval Office — Liberia, Senegal, Gabon, Mauritania and Guinea-Bissau — as “these are friends of mine now.”
Countries are not complaining about the rates outlined in his letters, he said, even though those tariffs have been generally close to the ones announced April 2 that rattled financial markets. The S&P 500 stock index rose Wednesday.
“We really haven’t had too many complaints because I’m keeping them at a very low number, very conservative as you would say,” Trump said.
Tariff uncertainty returns with Trump’s letters
Officials for the European Union, a major trade partner and source of Trump’s ire on trade, said Tuesday that they are not expecting to receive a letter from Trump listing tariff rates. The Republican president started the process of announcing tariff rates on Monday by hitting two major U.S. trading partners, Japan and South Korea, with import taxes of 25%.
According to Trump’s Wednesday letters, imports from Libya, Iraq, Algeria and Sri Lanka would be taxed at 30%, those from Moldova and Brunei at 25% and those from the Philippines at 20%. The tariffs would start Aug. 1.
The Census Bureau reported that last year the U.S. ran a trade imbalance on goods of $1.4 billion with Algeria, $5.9 billion with Iraq, $900 million with Libya, $4.9 billion with the Philippines, $2.6 billion with Sri Lanka, $111 million with Brunei and $85 million with Moldova. The imbalance represents the difference between what the U.S. exported to those countries and what it imported.
Taken together, the trade imbalances with those seven countries are essentially a rounding error in a U.S. economy with a gross domestic product of $30 trillion.
The letters were posted on Truth Social after the expiration of a 90-day negotiating period with a baseline levy of 10%. Trump is giving countries more time to negotiate with his Aug. 1 deadline, but he has insisted there will be no extensions for the countries that receive letters.
The president threatened additional tariffs on any country that attempts to retaliate.
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Associated Press writers Mauricio Savarese in Rio de Janeiro, David McHugh in Frankfurt, Germany, and Eileen Ng in Kuala Lumpur, Malaysia, contributed to this report.
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Yankees designate DJ LeMahieu for assignment, still owe him $15 million in 2026
NEW YORK — The writing was on the wall for DJ LeMahieu when manager Aaron Boone said that he would be a bench player for the New York Yankees. A day later, LeMahieu’s seven-year career in pinstripes ended when the Yankees announced Wednesday they had designated him for assignment.
Unless another team claims him, the club will owe LeMahieu about $22 million, which includes the rest of his $15 million salary this season, along with $15 million in 2026.
“It’s been a tough couple days, some hard conversations and then ultimately coming to this decision, obviously not easy for what’s been a great player,” Boone said. “He’s done a lot of great things for this organization, but in the end, I feel like this is the right thing to do at this time.”
Boone said LeMahieu did not ask for his release. According to the manager, LeMahieu had a long talk with general manager Brian Cashman on Tuesday night and they talked a couple of times Wednesday.
In LeMahieu’s place, the Yankees have added infielder Jorbit Vivas to the 26-man roster. With Jazz Chisholm Jr. moving over to second base and LeMahieu off the roster, Boone said Oswald Peraza, Vivas and JC Escarra will be the third-base options.
LeMahieu, 36, becomes the fourth notable veteran since 2023 to be placed on waivers by the club, joining Aaron Hicks, Josh Donaldson and Harrison Bader. When the Yankees released Hicks in May 2023, the club owed him $27.6 million — $10 million of which is being paid out this year.
LeMahieu originally signed a two-year, $24 million contract with the Yankees in 2019 before agreeing to a six-year, $90 million extension following the shortened 2020 season, in which he finished third in the American League MVP race behind Jose Abreu and José Ramírez. But since then, LeMahieu’s offense has cratered as he’s dealt with several lower-body injuries. His 99 wRC+ since the start of the 2021 season is the 20th-worst among all major-league hitters with at least 2,000 plate appearances.
With LeMahieu no longer having the positional versatility he once possessed, his departure from the Yankees became inevitable. In announcing LeMahieu’s benching Tuesday, Boone said it was a “challenge” physically for him to play third base. This was after the club planned on having LeMahieu be an option to start at the position entering the 2025 season, but a left calf injury sustained in spring training made that no longer possible.
His defense at second base became untenable as he displayed limited range in the middle of the diamond. That left the Yankees no other option but to move Chisholm back to second. On their active roster, the Yankees already have Giancarlo Stanton, who is incapable of playing the field. Having two such players, with LeMahieu being less of a threat offensively than Stanton, proved impossible.
LeMahieu finishes his Yankees career with two top-five MVP finishes, two Silver Slugger Awards and a Gold Glove Award as a utility infielder in 2022.
— The Athletic’s Brendan Kuty contributed to this report.
(Photo: New York Yankees / Getty Images)
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The US is having its worst year for measles in more than three decades
The U.S. is having its worst year for measles spread in more than three decades, and the year is only half over.
The national case count reached 1,288 on Wednesday, according to the U.S. Centers for Disease Control and Prevention, though public health experts say the true figure may be higher.
The CDC’s count is 14 more than 2019, when America almost lost its status of having eliminated the vaccine-preventable illness — something that could happen this year if the virus spreads without stopping for 12 months. But the U.S. is far from 1991, when there were 9,643 confirmed cases.
In a short statement, the federal government said that the CDC “continues to recommend (measles, mumps and rubella) vaccines as the best way to protect against measles.” It also said it is “supporting community efforts” to tamp down ongoing outbreaks as requested.
Fourteen states have active outbreaks; four other states’ outbreaks have ended. The largest outbreak started five months ago in undervaccinated communities in West Texas. Three people have died — two children in Texas and an adult in New Mexico — and dozens of people have been hospitalized across the U.S.
But there are signs that transmission is slowing, especially in Texas. Lubbock County’s hospitals treated most of the sickest patients in the region, but the county hasn’t seen a new case in 50 days, public health director Katherine Wells said.
“What concerned me early on in this outbreak was is it spreading to other parts of the United States, and that’s definitely what’s happening now,” she said.
In 2000, the World Health Organization and CDC said measles had been eliminated from the U.S. The closer a disease gets to eradication, the harder it can seem to stamp it out, said Dr. Jonathan Temte, a family physician in Wisconsin who helped certify that distinction 25 years ago.
It’s hard to see measles cases break records despite the widespread availability of a vaccine, he added. The measles, mumps and rubella vaccine is safe and is 97% effective at preventing measles after two doses.
“When we have tools that can be really helpful and see that they’re discarded for no good reason, it’s met with a little bit of melancholy on our part,” Temte said of public health officials and primary care providers.
Wells said she is concerned about continuing vaccine hesitancy. A recent study found childhood vaccination rates against measles fell after the COVID-19 pandemic in nearly 80% of the more than 2,000 U.S. counties with available data, including in states that are battling outbreaks this year. And CDC data showed that only 92.7% of kindergarteners in the U.S. had the measles, mumps and rubella vaccine in the 2023-2024 school year, below the 95% needed to prevent outbreaks.
State and federal leaders have for years kept funding stagnant for local public health departments’ vaccination programs that are tasked with reversing the trend. Wells said she talks with local public health leaders nationwide about how to prepare for an outbreak, but also says the system needs more investment.
“What we’re seeing with measles is a little bit of a ‘canary in a coal mine,’” said Lauren Gardner, leader of Johns Hopkins University’s independent measles and COVID-19 tracking databases. “It’s indicative of a problem that we know exists with vaccination attitudes in this county and just, I think, likely to get worse.”
Currently, North America has three other major measles outbreaks: 2,966 cases in Chihuahua state, Mexico, 2,223 cases in Ontario, Canada and 1,246 in Alberta, Canada. The Ontario, Chihuahua and Texas outbreaks stem from large Mennonite communities in the regions. Mennonite churches do not formally discourage vaccination, though more conservative Mennonite communities historically have low vaccination rates and a distrust of government.
In 2019, the CDC identified 22 outbreaks with the largest in two separate clusters in New York — 412 in New York state and 702 in New York City. These were linked because measles was spreading through close-knit Orthodox Jewish communities, the CDC said.
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AP videojournalist Laura Bargfeld contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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