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GSK (GSK.L), opens new tab said on Wednesday it plans to invest $30 billion in research and development and supply chain infrastructure in the United States over the next five years, after U.S. President Donald Trump arrived in Britain for an unprecedented second state visit to seal investment deals. The company said its new facilities will "bridge R&D and manufacturing across both the U.S. and UK, strengthening the two countries' leadership in life sciences". Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. London-based GSK said the investment includes $1.2 billion for the construction of a new factory at Upper Merion, Pennsylvania, to produce new medicines for respiratory disease and cancer, with construction planned to commence in 2026. It will also invest in AI and advanced digital technology capabilities across GSK's existing five manufacturing sites in the country, along with new drug substance manufacturing capabilities and improved device and auto-injector assembly. GSK is the latest drugmaker to scale up its U.S. footprint as Trump threatens to impose import tariffs on the industry and seeks to boost domestic manufacturing. The sector has historically been spared from trade disputes. "This landmark investment will create tens of thousands...

Swiss drugmaker Novartis (NOVN.S), opens new tab and drug developer Monte Rosa Therapeutics (GLUE.O), opens new tab agreed to an up to $5.7 billion licensing deal to develop treatments for immune-related diseases, the companies said on Monday, marking their second partnership in less than a year. Under the agreement, Monte Rosa will receive $120 million upfront and could earn additional milestone payments and royalties. Shares of the Boston based company jumped 50% in early morning trading after the announcement. Immune-related diseases occur when the immune system mistakenly attacks healthy tissues, causing inflammation and damage. These hard-to-treat conditions can severely impact patients' quality of life. The deal grants Novartis exclusive rights to an undisclosed drug discovery target and options to license two additional programs from Monte Rosa’s early stage immunology portfolio. The agreement represents "additional validation" of Monte Rosa's molecular glue degrader discovery platform from an existing large pharma partner, Wedbush’s Robert Driscoll said. Monte Rosa’s platform, QuEEN, uses artificial intelligence and machine learning to discover and develop new degraders - small molecules designed to break down disease-causing proteins - which Novartis will take into clinical development and commercialisation. The deal allows Monte Rosa to leverage Novartis' development capabilities to drive programs forward, and use the cash...

Ohio is taking steps to more tightly regulate how some large drug-compounding pharmacies in the state operate, including those making weight-loss drug copies, by limiting the amount of medicine they keep on hand. The move could have implications for online telehealth companies that rely on Ohio-based pharmacies producing copies in specialized doses, including one in the state owned by Hims and Hers (HIMS.N), opens new tab. Hims and other telehealth companies flourished over the last year when a shortage of Novo Nordisk's (NOVOb.CO), opens new tab Wegovy and Eli Lilly's (LLY.N), opens new tab Zepbound allowed them to compound mass quantities, but are now selling what they call individualized doses. During the shortage, copies of Wegovy and Zepbound were estimated to have risen to millions of doses. Novo and Lilly dispute that their production is legal. The Ohio Board of Pharmacy said a new regulation will target the batches large pharmacies produce in anticipation of prescriptions, limiting them to 250 units of a drug at a time. It applies to those that make sterile injectable drugs, including the popular weight-loss drugs. Details of the regulation have not previously been reported. “It’s meant to ensure is patient-specific and not creating mass production of these...

Drugmaker Eli Lilly said on Tuesday it is launching an artificial intelligence and machine learning platform that provides biotech companies access to drug discovery models trained on years of its research data. Drug developers are increasing adoption of AI technologies for discovery and safety testing to get faster and cheaper results, in line with an FDA push to reduce animal testing in the near future. Earlier in the year, Jefferies analysts had pegged AI-related research and development spend to reach about $30 billion to $40 billion by 2040. Lilly's platform, TuneLab, consists of AI models which include proprietary data obtained at a cost of over $1 billion. "Lilly TuneLab was created to be an equalizer so that smaller companies can access some of the same AI capabilities used every day by Lilly scientists," said chief scientific officer Daniel Skovronsky. Privately held companies Circle Pharma and insitro said they are partnering with Lilly for TuneLab. Circle will be using Lilly's platform to develop cancer therapies while insitro will build new AI models that will be used by TuneLab for the discovery of small molecule therapies. TuneLab works on datasets representing experimental data obtained with hundreds of thousands of unique molecules. In return for access, selected biotech...

The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the country’s first disease-modifying therapy for autoimmune type 1 diabetes (T1D). The treatment is now authorized for use in adult and pediatric patients aged eight and older with stage 2 T1D, aiming to delay the onset of stage 3, insulin-dependent T1D. The approval follows a priority review, underscoring the NMPA’s recognition of Tzield’s innovative therapeutic potential, particularly for pediatric patients at risk of progressing to full-blown diabetes. Backed by Strong Clinical Data Tzield’s approval is based on the TN-10 Phase 2 trial, which demonstrated that a 14-day course of Tzield significantly delayed disease progression. Patients receiving Tzield had a median delay of 48.4 months before progressing to stage 3 T1D, compared to 24.4 months in the placebo group. “This approval represents the beginning of a new era of care for stage 2 type 1 diabetes patients in China,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “Tzield is the first approved advanced therapy that slows down the loss of beta-cell function, potentially giving people more time without the burden of daily treatment.” Shifting the Standard of Care in China Tzield’s approval aligns with the November 2024 Chinese expert consensus guidelines, which...

-AbbVie shares rose 4% to a record high on Thursday after the U.S. drugmaker said it expected no generic competition for its blockbuster immunology drug Rinvoq until 2037, a four-year extension, according to some analysts. Rinvoq, used for the treatment of rheumatoid arthritis and other autoimmune diseases, is AbbVie's second best-selling drug behind Skyrizi. The company has been doubling down on the immunology treatments to counter the drop in sales of arthritis treatment Humira, its once bestselling drug that is battling competition from several cheaper biosimilars in the U.S. since 2023. The settlement with some generic drugmakers, which is subject to certain provisions, is expected to prevent sales erosion of Rinvoq from generic competitors until April 2037. J.P. Morgan analyst Chris Schott said the extension gives AbbVie "several more years of runway on one of its key growth drivers", providing more time to develop its experimental drugs ahead of major loss of exclusivity in the mid-2030s. Rinvoq generated sales of $5.97 billion, or more than 10% of the company's total revenue, in 2024. Skyrizi and Rinvoq are expected to together bring in more than $31 billion in 2027, according to AbbVie.

Kenvue's interim CEO Kirk Perry met Robert F. Kennedy Jr. to try and dissuade him from listing Tylenol as a potential cause of autism in an upcoming report, the Wall Street Journal said on Friday, citing a person familiar with the matter. Perry argued at the hastily scheduled meeting this week that there was no clear link between the two, the report said. WSJ reported on September 5 that the U.S. health secretary planned to announce that the use of Tylenol, a popular over-the-counter pain medication, in pregnant women was potentially linked to autism - contrary to medical guidelines that say it is safe to use. Kenvue shares fell more than 9% to $18.62 after the report last week, but have since recovered slightly. The U.S. Department of Health and Human Services did not immediately respond to a Reuters request for comment. As we would with any regulator who reaches out to us, we engaged in a scientific exchange with the secretary and members of his staff as it relates to the safety of our products, Kenvue said in an emailed response. The company said it continues to believe that taking acetaminophen - the active ingredient in Tylenol - does not cause autism and that...

Wegovy-maker Novo Nordisk (NOVOb.CO), opens new tab will cut 9,000 jobs, or about 11.5% of its workforce, in a restructuring to save 8 billion Danish crowns ($1.26 billion) annually, it said on Wednesday, as it battles rising pressure from U.S. rival Eli Lilly (LLY.N), opens new tab. "Novo Nordisk today announced a company-wide transformation to simplify its organisation, improve the speed of decision-making, and reallocate resources towards the company's growth opportunities in diabetes and obesity," it said in a statement. The company, which is also known for its Ozempic diabetes treatment, already said in August that it had implemented a global hiring freeze covering job roles that were not critical for its business. Novo, which currently has 78,400 positions globally, said about 5,000 of the job cuts will be in its native Denmark. "Our markets are evolving, particularly in obesity, as it has become more competitive and consumer-driven. Our company must evolve as well," newly appointed CEO Mike Doustdar said in the statement. "This means instilling an increased performance-based culture, deploying our resources ever more effectively, and prioritising investment where it will have the most impact – behind our leading therapy areas," he added. As part of the restructuring, Novo will report one-off restructuring costs...

A next-generation cancer immunotherapy by BioNTech and partner Bristol Myers Squibb (BMY.N), opens new tab led to encouraging tumour shrinkage in a mid-stage trial on small cell lung cancer that has started spreading, the German biotech firm said on Monday. A Phase II trial showed that 76.3% of the 38 participants on the drug BNT327, also know as pumitamig, who qualified for an interim analysis saw their tumours shrink, BioNTech said in a statement. Keep up with the latest medical breakthroughs and healthcare trends with the demonstrated a manageable safety profile with no new safety concerns and a low rate of people dropping out due to side effects, it added. The drug is already being tested in a Phase III lung cancer trial. Bristol Myers in June agreed to pay up to $11.1 billion to collaborate with BioNTech on the experimental drug, betting on a next-generation cancer immunotherapy that could take on rival Merck & Co's best-selling drug Keytruda. Several rival companies are pursuing an approach similar to pumitamig, which is designed to activate the immune system - like the established drug class including Keytruda - but also to cut a tumour off from its blood supply.

 Eli Lilly's (LLY.N), opens new tab blood cancer treatment Jaypirca helped patients live longer without the disease getting worse, the U.S. drugmaker said on Monday, meeting the main goal in a late-stage study in previously untreated patients. The drug, chemically known as pirtobrutinib, was tested in patients with a type of chronic lymphocytic leukemia, or small lymphocytic lymphoma (CLL/SLL), compared to chemoimmunotherapy. The disease is characterized by an increased production of abnormal white blood cells that have difficulty fighting infections. Jaypirca is currently approved for patients with CLL/SLL and mantle-cell lymphoma, a rare type of blood cancer, who have had at least two lines of therapy.