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-Moderna said on Tuesday its updated COVID-19 vaccine formulation elicited a strong immune response in all adults aged 65 and older, as well as in individuals aged 12 to 64 with at least one underlying risk condition. Preliminary data from an ongoing post-marketing study indicated that the vaccine, mNEXSPIKE, on average, showed greater than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant — currently one of the Sars-CoV-2 variants under monitoring with increasing prevalence globally. The trial was evaluating safety, tolerability and immunogenicity of the 2025-2026 formula of mNEXSPIKE. The safety profile of the vaccine was consistent with previous studies, the company said. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID-19 shot, Spikevax, and lower-than-expected uptake of its respiratory syncytial virus vaccine. The U.S. Food and Drug Administration had approved mNEXSPIKE in May, the first endorsement since the regulator tightened requirements for COVID-19 vaccines and said it plans to require new clinical trials for approval of annual boosters for healthy Americans under age 65. Spikevax is approved for individuals aged 65 and older, and for those aged six months to 64 who are at risk for severe disease. The data for mNEXSPIKE...

Pharmaceutical giant Eli Lilly and Co. plans to build a $6.5 billion manufacturing plant at Houston’s Generation Park. More than 300 locations in the U.S. competed for the factory. The Houston site will be the first major pharmaceutical manufacturing plant in Texas, according to the Greater Houston Partnership. Lilly said it plans to hire 615 full-time workers for the 236-acre plant, including engineers, scientists and lab technicians. The company will collaborate with local colleges and universities to help build its talent pipeline. The plant will also generate an estimated 4,000 construction jobs. Lilly said every dollar it spends in the Houston area will contribute an additional $4 to the local economy. “This is a transformative moment for the Houston region and our life sciences industry,” Steve Kean, president and CEO of the Greater Houston Partnership, said in a release. “The Lilly project represents one of the largest for-profit life sciences investments in Texas history and is a powerful endorsement of Houston’s growing position as a global hub for innovation, advanced manufacturing, and biomedical excellence.” The factory, expected to go online by 2030, will make small-molecule medicines for fields such as oncology, immunology and neuroscience. Perhaps most notably, the site will manufacture orforglipron, Lilly's first oral...

Bristol Myers Squibb (BMY.N), opens new tab (BMS) plans to launch schizophrenia drug Cobenfy in the UK next year at a price matching its U.S. list price, it said on Monday. Cobenfy, a new type of antipsychotic medicine that activates proteins called muscarinic receptors in the central nervous system, carries a U.S. list price of $1,850 a month, or about $22,500 annually. The company's announcement follows mounting pressure on drugmakers to lower their U.S. prices. BMS was one of 17 drugmakers to receive letters from U.S. President Donald Trump in July outlining how they should cut prices to match those paid overseas. Eli Lilly (LLY.N), opens new tab, another recipient, said in August that it would raise the UK list price of its weight-loss treatment Mounjaro by up to 170% for private payers from September. Drugmakers and the Trump administration have met to discuss ways to raise overseas drug prices to offset U.S. cuts, Reuters reported in August. The U.S. pays more for prescription drugs than any other country, often nearly three times as much as other developed nations. "We agree with the Trump administration that other countries need to pay their fair share," said Adam Lenkowsky, chief commercialization officer at BMS. Lenkowsky said the company...

Zealand Pharma (ZELA.CO), opens new tab is considering a direct-to-patient sales model for the experimental weight-loss drug it is developing with Roche (ROG.S), opens new tab alongside traditional insurer channels, its CEO told Reuters on Monday. The company is expecting results from its mid-stage clinical trial of the drug, petrelintide, in the first half of 2026, and plans to begin a late-stage trial in the second half. It announced an up to $5.3 billion deal with Roche to co-develop the drug in March. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. In an interview, Zealand CEO Adam Steensberg said the company is mulling a direct-to-consumer strategy from the outset because of how the market has evolved since Novo Nordisk (NOVOb.CO), opens new tab and Eli Lilly (LLY.N), opens new tab launched their GLP-1 therapies from 2021 onwards. After encountering patient access hurdles and struggling to secure broad insurance coverage in the U.S., both drugmakers later launched direct-to-consumer online platforms. "We expect this (direct-to-consumer) market will continue to grow," Steensberg said. Several large drugmakers including Roche, Lilly and Pfizer (PFE.N), opens new tab have said they are open to selling some of their bestselling...

Novo Nordisk, looking to turn around slowing growth of its blockbuster weight-loss drug Wegovy, plans to test whether its next-generation obesity drugs can treat a broader range of related conditions from sleep problems to knee pain. The Danish drugmaker aims to generate evidence across both severe and more common obesity-related conditions that affect patients' daily lives, including knee osteoarthritis and sleep apnea, Martin Holst Lange, Novo's head of research and development, told Reuters in an interview during the European Association for the Study of Diabetes conference in Vienna. "We do know that obesity is actually related to more than 200 different co-morbidities," Lange said. The company is battling to reignite growth and fend off competition from U.S. rival Eli Lilly, with some investors calling for Novo to expand beyond its traditional focus on diabetes and obesity treatments to spur sales. Lange said the treatment needs of obese patients could vary widely, driving the company to develop a range of options. TESTING SEMAGLUTIDE FOR ALZHEIMER'S DISEASE Novo has not disclosed which conditions it plans to study in trials of its experimental therapies CagriSema and amycretin. It has already secured regulatory approval for semaglutide as a treatment to reduce the risk of major cardiovascular events such as...

Pfizer said on Monday it would acquire weight-loss drug developer Metsera in a deal valued up to $7.3 billion, including future payments, to secure its position in the lucrative obesity treatment market. The global obesity drug market, projected to reach $150 billion by the early 2030s, has boomed over the last few years, driven by the success of highly effective GLP-1-targeting therapies from companies such as Novo Nordisk and Eli Lilly — both fiercely competing for market dominance. Drugmakers have also been racing to develop next-generation treatments for obesity, including drugs that target other hormones and help preserve muscle while losing fat, to establish their presence in the market. Pfizer CEO Albert Bourla said Metsera’s acquisition “propels Pfizer into this key therapeutic area” and would leverage the company’s cardiometabolic expertise and global infrastructure to accelerate next-generation obesity medicines. The deal follows Pfizer’s recent setbacks in its own development efforts with weight-loss pill danuglipron. The company had scrapped the development of a once-a-day version of danuglipron in April after a trial patient experienced potential drug-induced liver injury, which resolved after the medication was stopped. It had discontinued the development of a twice-daily version in late 2023 due to various side effects. The latest deal could be...

Bayer Chief Executive Bill Anderson said the company is making "remarkable progress" in overcoming longstanding challenges, including a weak drug development pipeline, after an internal management overhaul. Speaking at a press event in San Sebastian, Spain, Anderson said Bayer had fundamentally redesigned itself and was on track to overcome years of crisis, though a "long way to go" was still ahead. At the briefing, drug unit head Stefan Oelrich said sales of cancer drug Nubeqa and kidney treatment Kerendia were strong, and heart drug Beyonttra, also known as acoramidis, was now seen as generating more than $1 billion in its peak sales year. Overall, the sales loss from the expiry of patents for established stroke prevention pill Xarelto and for an older version of eye drug Eylea should be offset by newer products, he added. Bayer said separately it has started the third phase of human testing of an experimental stem cell therapy for Parkinson's disease, to support longer-term growth ambitions. CEO Anderson reaffirmed Bayer's goal to make meaningful progress on resolving approximately 61,000 outstanding glyphosate cases by the end of 2026, where plaintiffs claim a cancer-causing effect of the weedkiller. Anderson also said U.S. tariffs on imports were not a major topic for the...

Shares in Roche Holding rose around 2% on Monday, outperforming a broadly unchanged European healthcare index, as the drugmaker said it was advancing its experimental obesity drug CT-388 to a late-stage clinical trial. Roche acquired this drug candidate in late 2023 when it acquired U.S. biotech firm Carmot Therapeutics in its first major bid to challenge the dominant makers of weight-loss drugs Novo Nordisk and Eli Lilly. Roche shares jumped nearly 5% when it reported results from an early-stage trial of this drug showing it led to significant weight loss. The Swiss drugmaker was presenting an update on its obesity drugs pipeline at an investor day in London. Roche's pharmaceutical division head Teresa Graham told investors that the company aims to become a major player in the lucrative obesity drug market and plans to secure a strong entry to this market with competitive products by 2030. "Our goal is to become a Top 3 player (in the obesity drug market), and I want you to know I'm serious about this goal," Teresa Graham, the head of Roche's pharmaceutical division, told investors, saying that Roche had a track record of successfully moving into new therapeutic areas with competitive drugs that became blockbusters.

Novartis has increased its stockpiles of pharmaceuticals in the United States and is well prepared should its products be hit by President Donald Trump's tariffs, its chief executive said in an interview published on Saturday. Pharmaceuticals are currently exempt from the 39% tariffs Washington imposed on Switzerland last month, although the industry is awaiting the outcome of a investigation which could lead to sectoral import duties. The U.S. also reached a bilateral trade deal with the European Union in July, which includes a 15% tariff on pharmaceuticals, except for some generic drugs. "We have significantly increased our stockpiles in the U.S., so they will certainly last until mid-2026," CEO Vas Narasimhan told Swiss newspaper Neue Zuercher Zeitung. Novartis has already announced $23 billion in medium-term investments in the U.S. and aims to manufacture its most important products for the American market locally, he added. "It will likely take three to four years to get there. But I estimate that we can make significant shifts within the next two years, for example, to carry out some of the final filling and packaging in the U.S.," he said. "This should allow us to fully mitigate any tariffs." Narasimhan said it was "difficult to estimate" whether potential tariffs of...

The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence. Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.” While the CDC’s position was hailed by HIV advocacy groups, many pointed to the remaining roadblocks that prevent wider access, especially for those without health insurance. In August, CVS Health confirmed that it won’t currently be adding the drug to its commercial plans or Affordable Care Act...