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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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This is a non-spoiler advance review for the first four episodes of Dexter: Resurrection, which premieres July 11, 2025 with two episodes on Paramount+.
Following a pair of Dexter spin-offs that did a great job of smoothing over the dumb, jagged edges of a much-maligned series finale without retconning anything or conveniently forgetting the Showtime drama’s many weaknesses, Dexter: Resurrection finds a reson to keep the shenanigans going. This fun, pulpy continuation of the deathless serial-killer series pairs well with last year’s surprisingly good prequel Dexter: Original, owning everything good and bad that’s happened in the saga of murderer-of-murderers Dexter Morgan (Michael C. Hall) – and that’s a lovely miracle in its own way. As Cobra Kai did for The Karate Kid III and the third Star Wars prequel did for the second, these new Dexter seasons acknowledge the bumps in the road while also using them to lay a path forward for the Bay Harbor Butcher and those who pursue him.
It helps that original showrunner Clyde Phillips has been back on board for New Blood, Original Sin, and now Resurrection. It’s a big reason why they match the tone and tenor of the original series’ early seasons. Resurrection is as its title suggests: Dexter could have died at the end of New Blood, but the door was left open. So what happens now that Dexter’s alive and without a secret identity? Angel Batista – sorry, that’s Captain Angel Batista, played once more by David Zayas – has legally brought Dexter back and with that… has he also brought back the beast that is the Bay Harbor Butcher?
The first episode of Resurrection takes its time to sort out the many reasons for continuing. At face value, it’s Dexter (the character), recovering from a near-fatal wound, wondering if he deserves to live. In a winking way, however, it’s Dexter (the show) asking out loud “Why more?” And, crazy enough, there’s a halfway decent answer. Springboarding from Original Sin’s and its flashback to Harry’s relationship with Dexter’s mom, Laura, Resurrection gives Dexter a new sense of purpose: He’ll guide and provide cover for his homicidal son Harrison (Jack Alcott) as Harry did for Dexter, the father making sure his kid doesn’t wind up on death row due to clumsy error. Naturally, Dexter and Harrison have a different relationship following New Blood, so Dexter decides to work in stealth mode, secretly checking over Harrison’s work – while also possibly, after 40 years, developing a true sense of empathy. Took him long enough.
The distractions and the obstacles inevitably come when Dexter once more feels the sinister urge to get back into the Butcher business. And so running in the background of Resurrection is a really silly (but also not totally out of bounds) story about a super wealthy dude who loves to “collect“ serial killers as regular dinner guests. Dexter sabotaging himself (as Dexter does) leads him into this wicked web of sublime guest stars – like Peter Dinklage, Uma Thurman, Krysten Ritter, Neil Patrick Harris, Eric Stonestreet, and David Dastmalchian – and an exciting move to New York City. This new, bustling hunting ground may be one of the most overused settings in movies and TV, but it helps juice up Dexter’s story nonetheless.
Dinklage’s character, charity gala maven Leon Prater, also provides an in-house reason to reflect on the legacy of Dexter. Within this specific world of killers both real and fictional, the Butcher is a legend – and viewed (and revered) differently because his victims are fellow killers. And while Resurrection ruminates about its protagonist’s life as a vigilante of sorts, it also continues to pull from Dexter history by making Batista, quite possibly, the first “gonna catch Dexter!” antagonist we’ll actually root for. He was close to Dexter, and now he needs a lot of answers regarding the loss of his friends and loved ones. He seeks justice for characters we actually knew and cared about. When Batista arrives on the scene in these four episodes, it evokes a sense of relief more than it does an “Oh nooo!” reaction. For that, there’s another savant-style investigator played by Kadia Saraf. This allows Batista, in a nice, full-circle way, to become the unexpected hero of Resurrection.
New Blood threw out the option of killing Dexter, which was something fans and critics seemed to want and need (but never got) back in season 8. Resurrection, after four episodes, seems to be leaning toward stark revelation. Not death in a remote snowy woods somewhere but Dexter Morgan (possibly) being outed for his crimes and (maybe) even paying for them in meaningful ways. This is another way Resurrection nicely locks arms with Original Sin, where we saw Dexter and Batista (and the late María LaGuerta) become co-workers and friends for the first time.
Aside from Julia Jones’ Angela, everything from New Blood is intact here, with Alcott remaining a vital (and good) part of the story. Harrison could have easily been an exhausting, bitter character, but the writing and Alcott’s performance kept the damage to a minimum, side-stepping most TV-teen clichés. In Resurrection we get a Harrison who’s learned the “code,” but now doesn’t have the benefit of a guardian angel guiding him. Everything makes sense here, motivation-wise and plot-wise, so Resurrection already has several legs up on seasons 5 through 8.
I’ll say this though: Dexter’s gonna Dexter. You’re gonna get the same trite inner monologue where people don’t know they’re talking to a killer and Dexter gets to be coy and corny with his thoughts. You’re going to get characters wanting to be Dexter’s best friend after having, basically, a one-sided conversation with him for a minute. Sometimes things will just fall into place in ridiculously serendipitous fashion. These are still the hallmarks, and Resurrection embraces them – it’s not desperate to court new viewers or old fans who jumped ship during the bad years. This Dexter for people who are okay with what Dexter still is.
That being that, it does find a compelling way back in. It’s a thrilling follow up to New Blood that also lands better now with Original Sin filling all the gaps. We’re long past due a full and official wrap up, and with a second season of Original Sin on the way, it’s hard to imagine Dexter’s tale ending here. But this early stretch of Resurrection certainly have all the perfect ingredients for a final bow.
Google has launched a suite of its AI-powered advertising tools in India, which debuted in the U.S. in May, as the repeal of the so-called “Google tax” has made the South Asian market more attractive to global tech firms selling online ads.
In March, the Indian government scrapped its 6% levy on digital advertisements, effective in April, as a move to address some of the trade concerns raised by the Trump administration.
The United States Trade Representative had criticized the levy by calling it “discriminatory and unreasonable,” as domestic companies were exempt. Its repeal would ease costs for tech giants, including Google, Meta, and Amazon.
On Thursday, Google hosted the local version of its Marketing Live event to debut its AI-powered tools for Indian marketers.
One of the tools is “Generated for You”, available within Product Studio, that identifies relevant content opportunities across shopping catalogs and pre-generates images and videos via AI that merchants can save or publish across Google platforms. Another tool is an opt-in feature called Smart Bidding Exploration in search campaigns, which is built on existing Smart Bidding and uses AI to find newer, qualified leads that merchants wouldn’t have captured or bid on typically.
Plus, Google introduced new agentic capabilities in Google Ads and Analytics.
“These agentic tools can learn from advertising inputs, including datasets, landing pages, assets, and real-time campaign performance, to take the guesswork out of achieving business goals,” Dan Taylor, Vice President for Global Ads at Google, said at a virtual media roundtable.
Google brought AI Max for Search Campaigns, which aims to enhance search ad campaign performance by identifying more relevant and high-performing search queries by learning from brands’ landing pages, their existing ads, and existing keyword lists.
Indian online marketplace for used electronics goods, Cashify, saw its conversions up by 15% and customer acquisition costs reduced by 12% after deploying AI Max during its early testing, Google said.
Google also announced that ads will start appearing on AI Overviews in India later this year.
Additionally, the company has introduced its shoppable connected TV ads on YouTube in India. YouTube’s masthead on mobile will now also start serving ads in the country.
YouTube on connected TVs has been the most-watched streaming service on television in India over the past year, said Roma Datta Chobey, managing director of Digital Native Industries at Google India.
Similarly, the country has been a significant market for YouTube Shorts, with short videos on the platform viewed trillions of times since launch. As many as 87% of Indian consumers watch YouTube or Shorts as part of their shopping journey, Chobey said.
India’s digital advertising presence is growing, as the world’s second-largest internet market continues to see more users come online. The country’s digital ad market is projected to grow over 20% year-over-year, reaching nearly $7 billion by the end of 2025, per a recent Dentsu Digital Advertising report.
“India is such a thriving digital ecosystem. We have the largest number of users who are actively trying and testing our products. So, that’s really the reason behind us getting these innovations to India faster,” Chobey said, in response to TechCrunch’s question about the timing of the new AI ad tools.
Google confirmed to TechCrunch that its newly launched features including AI Max for Search Campaigns, Smart Bidding Exploration, YouTube’s shoppable masthead and CTV, and Performance Max Retention-Only Mode support Hindi to improve local campaign compatibility. Additionally, the company introduced state-level urban and rural audience filters for Indian advertisers to enable more granular media planning, buying, and reporting.
India has long been a key market for Google, not just because it hosts the company’s largest user base but also due to consistent growth in ad revenues. In fiscal year 2024, Google’s gross ad revenue in India increased 11% year-over-year to ₹312.21 billion ($3.6 billion), while its net advertising revenue rose 18% to ₹27.43 billion ($320 million).
A commitment to tackle the smuggling gangspublished at 05:24 British Summer Time
Damian Grammaticas
Political correspondent
At this summit, the UK and France are promising that they will make progress on “new and innovative solutions, including a new deterrent” to “break the business model” of the gangs smuggling people across the Channel.
The deal that’s been under discussion envisages the UK returning migrants to France. For each individual taken back, France would transfer one asylum seeker to the UK, probably someone with a family connection or genuine reason to seek sanctuary here.
What’s not known are the potential numbers involved and whether final details could be agreed this week.
When it comes to defence, the UK and France will sign a declaration saying that their independent nuclear deterrents could, in future, be co-ordinated, if an adversary was threatening either country, and there were no extreme threats they would not confront together.
There will also be joint development of new missiles and air defences, and support for Ukraine.
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