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GILEAD UNIT TO ACQUIRE CELL THERAPY DEVELOPER INTERIUS FOR $350 MILLION

Gilead Sciences’ (GILD.O) unit Kite Pharma said on Thursday it will acquire privately-held biotech firm Interius BioTherapeutics for $350 million in cash to advance CAR T-cell cancer therapies that are delivered directly into patients. The acquisition will enable Kite to use Interius’ platform to deliver cell therapy directly into patients, simplifying treatment processes and reducing costs, the company said. Kite said the deal, expected to close pending regulatory approvals, will reduce Gilead’s 2025 profit per share by about 23 cents to 25 cents. In CAR T-cell therapy, a patient’s T-cells, a key part of the immune system, are modified to better recognize and attack cancer cells. Traditional CAR T-cell therapies, including Kite’s approved blood cancer treatments Yescarta and Tecartus, involve taking immune cells from a patient. These are modified in a lab, and then put back into the patient’s body – a process that is both complex and expensive. Interius’ so-called “in-vivo” approach uses intravenous infusion to deliver DNA directly into cells, potentially accelerating and simplifying treatments, according to the Kite.

New drug formulation turns IV treatments into quick injections

Stanford Engineering researchers have developed a drug delivery platform that could enable patients with some cancers, autoimmune diseases, and metabolic disorders to receive protein-based treatments via easy injection. Patients with some cancers, autoimmune diseases, and metabolic disorders often endure time-consuming intravenous (IV) infusions to receive the best protein-based treatments available. Because these protein therapeutics require high doses to be effective and are typically formulated at low concentrations to remain stable, IV infusion has been, until now, the only option. Researchers at Stanford have developed a new delivery platform that allows these drugs to be stored and delivered in much higher concentrations. With this new formulation method, published Aug. 20 in Science Translational Medicine, many protein therapeutics could be injected quickly and smoothly with a standard syringe or autoinjector device. “This is a platform that potentially works with any biologic drug, so that we can inject it easily,” said Eric Appel, an associate professor of materials science and engineering and senior author on the paper. “That takes these treatments from a several-hour ordeal at a clinic with an IV infusion to something you can do in seconds with an autoinjector at your house.”

Health Rounds: GLP-1 drugs linked to lower cancer risks

LP-1 drugs for diabetes and weight loss may influence patients’ cancer risk, usually lowering it but sometimes possibly increasing it, new findings suggest. U.S. researchers reviewed 10 years of medical records from 43,317 users and 43,315 similar nonusers of Novo Nordisk’s type 2 diabetes drugs Victoza and Ozempic or its weight-loss medication Wegovy, or Eli Lilly’s Mounjaro for diabetes or Zepbound for weight loss. All volunteers were at risk for obesity-related cancers. Each year, out of every thousand participants, 13.6 users of GLP-1 drugs were diagnosed with any of 14 types of cancer, compared to 16.6 nonusers, the researchers reported in JAMA Oncology. After accounting for individual risk factors, the overall cancer risk was 17% lower in GLP-1 users. In particular, GLP-1 use was associated with a 25% lower risk of endometrial cancer, a 47% lower risk of ovarian cancer and a 31% lower risk of meningioma. GLP-1 drugs were also associated with a slight increase in risk for kidney cancer. The increase was not statistically significant, meaning it could have been due to chance – but an earlier study also found a higher risk of kidney cancer with use of GLP-1 drugs for diabetes, the authors note.

J&J to invest $2 billion to boost US manufacturing as drug tariffs loom

Johnson & Johnson said on Thursday it would invest $2 billion in North Carolina as it aims to expand its U.S. manufacturing presence amid looming drug import duties proposed by President Donald Trump's administration. Major drugmakers, including Eli Lilly and AstraZeneca, have also committed to shell out billions of dollars to scale up their U.S. footprint in response to Trump's efforts, including tariff threats. Earlier this month, Trump said he plans to impose phased-in tariffs for the pharmaceutical sector, which could start small and eventually rise to 250%. J&J said on Thursday it has reached a 10-year agreement with Tokyo-based contract drug developer Fujifilm Biotechnologies for its more than 160,000-square-foot manufacturing facility in Holly Springs, North Carolina, which would create about 120 new jobs. Fujifilm in April had signed a more than $3 billion deal with Regeneron to manufacture and supply drug products for the U.S.-based company at its North Carolina facility for a span of 10 years. J&J would also announce plans for additional manufacturing facilities in the U.S. and the expansion of current U.S. sites in the coming months. The healthcare conglomerate had said in March it would raise U.S. investments by 25% to more than $55 billion over the next four years,...

You can now give yourself an at-home flu vaccine

For the first time, Americans can get their seasonal flu vaccine at home. Starting Friday, eligible adults in 34 states can order the FluMist Home - a nasal spray - online ahead of the upcoming flu season, European drugmaker AstraZeneca announced, calling it a “transformational moment in the evolution of influenza protection.” FluMist was previously only available at pharmacies or doctors' offices. Now, interested people can go to www.FluMist.com to order the sprays, potentially saving time spent at a clinic or drug store. Once received, the vaccine should be stored in the refrigerator until it is used. Then, people between the ages of 18 and 49 years old can self-administer the vaccine. FluMist Home can be given to children and teens between the ages of two and 17 years old. A full dose is one spray in each nostril. FluMist may not prevent infection in everyone who takes it, but it works similarly to vaccines for measles and chickenpox. It contains weakened versions of viruses that trigger the immune system in the nose and throat, teaching it to build up immunity without causing infection. In rare cases, FluMist may cause serious side effects, including allergic reactions. But the most common side effects are a...

Viking’s oral pill reduces up to 12.2% weight but shares slump on higher patient exits

Viking Therapeutics said on Tuesday its experimental weight-loss pill helped people with obesity lose up to 12.2% of their body weight over 13 weeks in a keenly watched study. Yet, shares of the company slumped nearly 35% in premarket trading after data showed that more patients who received Viking's drug stopped taking the treatment, compared to those who received placebo in the mid-stage study. Oral drugs are expected to take a significant share of the projected $150 billion weight-loss market, driven by their ease of use compared with injections such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound. Viking's experimental oral pill is in a tight race with rival treatments being developed by the deeper-pocketed Novo and Lilly. Earlier this month, Eli Lilly said its experimental daily pill, orforglipron, showed a 12.4% weight loss in patients in a late-stage study over 72 weeks. In a separate trial, Novo's oral semaglutide has shown a weight loss of 15% over 68 weeks. Both the oral drugs are expected to be launched next year. Ahead of Viking's data, analysts expected weight loss in the range of 10% to 15% on average for the pill, known as VK2735. It had shown an 8.2% average weight-loss in a small...

Japan’s Takeda weighs India for global trials to speed up drug launches

Japanese drugmaker Takeda Pharmaceutical (4502.T), opens new tab is exploring the option of conducting global clinical trials in India to accelerate the launch of its innovative drugs in the world's most populous nation, its India head told Reuters. The plan comes at a time when India's clinical trials market is growing, powered by diverse patient pools, cost efficiency, and a fast-growing hospital network. Grand View Research expects the market to exceed $2 billion by 2030. "India is a strategic growth market for Takeda, and we are making significant long-term investments... in terms of innovation and building capabilities," said Annapurna Das, the general manager of Takeda's India operations. She did not share financial details of the investments. "We're exploring the opportunity of leveraging India's clinical trial ecosystem," Das said. Takeda is also open to partnering with local academia, healthcare providers and technology firms in India for innovation, Das said, without sharing more specifics. "At this point of time, we are still kind of exploring and evaluating how we want to go ahead," she added. Takeda's eventual aim is to integrate India's research and development "ecosystem" into its global pipeline and expand Indian patients' access to cutting-edge therapies in oncology, neuroscience, gastrointestinal health, and inflammation. The Japanese drugmaker aims...

China’s Bio-Thera Solutions licenses its arthritis drug to Germany’s STADA

China's Bio-Thera Solutions (688177.SS), opens new tab said on Thursday it has granted Germany's STADA Arzneimittel commercialisation rights for its arthritis drug BAT1806, opens new tab in the EU, UK, Switzerland, certain Middle East and North Africa regions, and certain members of the Commonwealth of Independent States. Upfront payment and milestone payments will total up to 136 million euros ($158.34 million), including an 8.5 million euro down payment, milestone payments up to 127.5 million euros, and a double-digit percentage of net sales as revenue sharing, the Shanghai-listed firm said in a stock exchange filing, opens new tab.

Drugmaker Novo Nordisk freezes hiring for non-critical jobs

Wegovy-maker Novo Nordisk (NOVOb.CO), opens new tab has implemented a global hiring freeze covering job roles that are not critical for its business, the company said on Wednesday. The company is battling competition from copycat versions of its blockbuster Wegovy obesity drug this year and could face layoffs as it battles rising pressure from its main rival Eli Lilly. "We currently have a hiring freeze in non-business critical areas," the company said in an emailed statement, without elaborating. Investors in July wiped $70 billion off the drugmaker's market value, after Novo - which became Europe's most valuable listed company following the launch of Wegovy in 2021 - issued a profit warning and named a company veteran as its new CEO. The new CEO, Mike Doustdar, who took the helm on August 7, told Danish broadcaster TV2 on his first day in office that he would look for cost savings throughout the company and also consider layoffs.

GLP-1 drugs linked to reduced symptoms in chronic skin condition hidradenitis suppurativa

A multicenter French study led by Rennes University Hospital reports potential benefits of glucagon-like peptide-1 receptor agonists for hidradenitis suppurativa (HS), with statistically significant reductions in HS-related scores at six months and at last follow-up. HS is a chronic skin condition that causes painful lumps and lesions in areas like the armpits, groin, and buttocks. Skin inflammation causes hair follicles to get blocked and the nearby sweat glands become inflamed, causing the lesions. The majority of HS patients are overweight or have obesity. Dysfunctional adipose tissue contributes to the pathophysiology by overproducing proinflammatory adipokines and cytokines, while reducing anti-inflammatory adiponectin. Weight loss, through diet or obesity surgery, has a beneficial effect on HS in most patients. Meaningful reductions remain a challenge. Glucagon-like peptide-1 receptor agonists, originally developed for type 2 diabetes, have demonstrated major efficacy in inducing weight loss and could also possess anti-inflammatory properties, prompting investigation into their impact on HS. In the study, "Glucagon-Like Peptide-1 Receptor Agonists in Hidradenitis Suppurativa," published in JAMA Dermatology, researchers conducted a retrospective multicenter cohort study to assess the impact of GLP-1 receptor agonists on HS outcomes. Among 66 patients with HS from 15 centers, median follow-up while taking GLP-1 receptor agonists was 18.5 months. Semaglutide was...