sitefansalaran Industry News

Privately held Iambic said on Monday it has entered a multi-year partnership worth more than $1.7 billion with Japan's Takeda Pharmaceutical (4502.T), opens new tab to use artificial intelligence to help design small-molecule drugs targeting cancer and gastrointestinal diseases. Under the agreement, Iambic will receive upfront payments and could earn more than $1.7 billion in development and commercial milestones, plus royalties on sales. The deal marks Takeda's latest move to embed artificial intelligence across its research operations, following a similar agreement with Nabla Bio last year focused on protein-based drugs. Drug developers are increasingly turning to AI technologies to speed up discovery and cut costs, with experts predicting timelines could be halved in coming years. Takeda will also gain access to NeuralPLexer, Iambic's model that predicts how drug molecules bind to proteins. Iambic Chief Executive Tom Miller told Reuters that understanding protein structure is critical in drug development. "If you don't know the shape of what you're trying to engage ... it's a lot like trying to make a sculpture in the dark," he said. Traditional drug discovery can take around six years before a compound reaches clinical trials. Iambic said its approach, combining AI predictions with automated laboratories, can compress that timeline to less than two...

Eli Lilly will buy Orna Therapeutics for up to $2.4 billion in cash, gaining access to a technology that allows patients' own cells to generate therapies inside the body, without the need to extract them. The deal, announced on Monday, is the latest in the flurry of transactions signed by the U.S. drugmaker over the last few months to diversify beyond obesity. Lilly shares were up more than 3% in morning trading. Orna is developing therapies that use a form of RNA called circular RNA, along with novel lipid nanoparticles. Its lead drug candidate, ORN-252, is in early stages of development. It is a type of treatment called chimeric antigen receptor T-cell, or CAR-T, targeting cells with a receptor called CD19. CAR-T therapies modify a patient's immune cells to recognize a specific target and destroy cancer cells. Drugmakers such as Bristol Myers Squibb, Gilead and Johnson & Johnson already offer CAR-T therapies to treat cancer, but most involve isolating the cells, altering and infusing them back into patients' bodies. Instead of modifying the cells in a lab, Orna aims to produce them "in vivo" or inside the body. Orna's platform has the potential to expand Lilly's capabilities in the oncology and immunology space, said BMO Capital...

Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia •Rilzabrutinib is the first and only investigational BTKi for warm autoimmune hemolytic anemia to be designated Breakthrough Therapy by the FDA •Rilzabrutinib helps address complex immune-system dysregulation through multi-immune modulation Rilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic potential The US Food and Drug Administration (FDA) has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disorder marked by the destruction of red blood cells. The Japanese Ministry of Health, Labour and Welfare has also provided rilzabrutinib an orphan designation for the same condition. Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study (clinical study identifier: NCT05002777) assessing the efficacy and safety of rilzabrutinib for patients with wAIHA. In addition, the new LUMINA 3 phase 3 study (clinical study identifier: NCT07086976), is assessing rilzabrutinib compared with placebo in patients with wAIHA. There is currently no approved treatment that specifically targets the underlying cause of this rare autoimmune condition, which...

•FDA on Friday said it would restrict GLP-1 ingredients •Novo, Lilly shares fell after Hims launched the pill on Thursday •Hims said the decision followed discussions with stakeholders Online telehealth company Hims & Hers on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it. "Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said. The FDA said on Friday that it plans to restrict GLP-1 ingredients used in compounded drugs that companies such as Hims and online pharmacies have marketed, citing concerns over quality, safety and potential violations of federal law. The Department of Health and Human Services said on Friday it would refer the company to the Department of Justice but did not make clear whether it could quickly halt the sale of the Hims' product, the cheapest GLP-1 therapy on the U.S. market. Reuters reported on Thursday that Hims would begin offering copies of Novo Nordisk's new Wegovy pill at an introductory price of $49 per month,...

China's Innovent Biologics has struck a new deal with Eli Lilly to develop immunology and oncology drugs, under which the U.S. drugmaker will pay $350 million upfront and as much as $8.5 billion more if milestones are met. Shares in Innovent surged 5% in early Monday trade. Under the agreement, which marks the seventh collaboration between the two firms, Innovent will lead the development of programs from concept through the completion of phase II clinical trials in China. Lilly will have an exclusive license to develop and commercialize the products outside of Greater China. "This alliance moves beyond traditional licensing to create a seamless, end-to-end innovation ecosystem," Innovent CEO Michael Yu said in a statement on Sunday, adding that it also validates Innovent's research and development capabilities. Innovent has also partnered with Lilly on projects such as the weight loss drug mazdutide. In addition to the $8.5 billion in payments tied to developmental, regulatory and commercial milestones, Innovent will also be eligible for royalties on net sales of products outside of Greater China.

Researchers have developed a nasal spray for flu prevention that has shown promising results in preliminary human trials. Seasonal influenza (the flu) is an acute respiratory infection that affects up to one billion people per year and causes hundreds of thousands of deaths. While flu shots can be effective, they are always a best guess because scientists are never fully certain about which strains will circulate. At best, they are only 50% effective, according to historical data. Another way to try and tackle the flu is experimental monoclonal antibodies, which are proteins that mimic the immune system's ability to fight off viruses, but these too have had limited success. Spraying inside the nostrils Scientists from Leyden Labs in the Netherlands and their partners have been working on a different approach: a spray you apply directly to the nostrils to block the virus at the point of entry. Their research is published in the journal Science Translational Medicine. The spray contains an antibody called CR9114, which was developed by the pharmaceutical company Johnson & Johnson. Unlike conventional vaccines that can only recognize specific flu strains, CR9114 can recognize and block almost all types of influenza A and B. Following successful tests in mice and macaques,...

Novo Nordisk (NOVOb.CO), opens new tab said on Wednesday it will launch some doses of its oral semaglutide for diabetes under the brand name Ozempic pill in the second quarter of this year. The company said the U.S. Food and Drug Administration has approved Ozempic tablets in 1.5 milligram, 4 milligram, and 9 milligram doses. The new Ozempic name is intended to help patients and health care professionals more easily recognize the available treatment options for type 2 diabetes, the company said. "Because Ozempic is so well known, people often ask whether there's an oral option for people with type 2 diabetes, without realizing Rybelsus has been available since 2019," said Ed Cinca, senior vice president of marketing & patient solutions at Novo Nordisk. Semaglutide tablets at 3 mg, 7 mg, and 14 mg doses have been available under the brand name Rybelsus for diabetes. The pill is also approved to reduce the risk of certain cardiovascular conditions in adults with type 2 diabetes who are at high risk for these events. The FDA had approved the new doses based on a bioequivalence study and the clinical trial data for Rybelsus, Novo said. The Danish drugmaker expects a decision from the health regulator on a 25...

Swiss pharmaceutical company Roche said on Saturday its experimental multiple sclerosis drug fenebrutinib met the main goal in a late-stage trial in patients with primary progressive multiple sclerosis, a rare form of the disease with few treatment options. In the Phase III study, fenebrutinib cut the risk of worsening disability by 12% compared with Roche's Ocrevus, the only approved therapy for PPMS, the Swiss drugmaker said. Separation of the treatment curves was seen after 24 weeks, and additional analyses suggested potential benefits in upper-limb function. PPMS is the least common form of multiple sclerosis and is marked by a steady progression of disability from the outset. Roche said fenebrutinib was the first experimental therapy in more than a decade to show a reduction in disability progression in a PPMS study. The company said it plans to submit the drug for regulatory approval once additional Phase III data from a relapsing MS trial are available, which it expects in the first half of 2026.

Amid the fast-moving rollout of the Wegovy pill, Novo Nordisk has taken to advertising’s biggest stage to help get the word out. After a week’s worth of social media teasers, Novo on Friday unveiled a commercial that’ll make its broadcast debut during Super Bowl LX on Feb. 8, marking the Danish pharma’s first-ever Super Bowl ad. The 90-second spot features an array of celebrities—“Saturday Night Live” stars Kenan Thompson and Ana Gasteyer, musician DJ Khaled and actors Danielle Brooks, Danny Trejo and John C. Reilly—all chosen for their “ability to connect” with audiences and their “unique and distinct styles of communication,” as Ed Cinca, Novo’s senior VP of marketing and patient solutions, told Fierce Pharma Marketing in an interview. The commercial starts with Thompson and Khaled sharing the “big news” that Wegovy is now available in pill form, after which Thompson suggests to viewers that “if there was a pill that made other helpful things possible, you’d take it.” A montage ensues, showing the stars wishing for pills that could improve their parallel parking skills, turn them into pro wrestlers, help them rescue more kittens and, as Gasteyer requests, make others “stop being so judgy about how to lose weight.” That last sentiment may...

fizer (PFE.N), opens new tab said on Tuesday its experimental obesity drug, which it acquired through the Metsera deal, showed up to 12.3% weight loss in patients without diabetes in a mid-stage trial. In November, Pfizer acquired Metsera for up to $10 billion following a fierce bidding war with Novo Nordisk (NOVOb.CO), opens new tab. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The mid-stage trial was studying the monthly maintenance dosing of the drug, PF’3944, to see if it could achieve continued weight loss when switching from weekly to monthly injections under the skin. These data show robust and continuous weight loss after switching to monthly dosing, with no plateau observed at week 28, the company said, adding that it expects the trend to continue as the study reaches week 64. Across both arms, five total participants discontinued from treatment due to side effects in the weekly phase and five total participants discontinued in the monthly phase.