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Britain's medicines regulator said on Thursday it approved GSK's (GSK.L), opens new tab Blujepa, an antibiotic pill, to treat uncomplicated urinary tract infections (UTIs) in females aged 12 and older. The active ingredient in Blujepa, chemically known as gepotidacin, targets and blocks two enzymes that bacteria need to replicate and multiply, making it work against many drug-resistant infections such as E. coli, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. It said the approval for the oral medication is for females who weigh at least 40kg (88lbs). GSK did not immediately respond to a Reuters request for a comment regarding the date of launch and pricing. The U.S. Food and Drug Administration in March approved the drug, which was expected to be launched in the U.S. in the second half of this year. GSK is banking on new drugs in its infectious diseases portfolio, including its recently launched respiratory syncytial virus vaccine, to make up for lost revenues from its best-selling medicines and looming patent losses for its HIV treatments.

Dynavax tested two variants of its candidate, Z-1018, in the trial of 92 people aged 50 through 69 years. All subjects injected with either of the vaccine variants showed a similar immune response to those given Shingrix, one month after the second dose. Dynavax Technologies said on Thursday its experimental shingles vaccine generated a similar immune response as GSK's blockbuster shot Shingrix, while showing a better safety profile, in early-to-mid-stage study. Shingles, or herpes zosteris, is a viral infection characterized by painful rashes that could lead to serious complications such as long-term nerve pain and vision loss. The disease is caused by the varicella-zoster virus, which also causes chickenpox, and affects about 1 million Americans each year, according to government data. Dynavax tested two variants of its candidate, Z-1018, in the trial of 92 people aged 50 through 69 years. All subjects injected with either of the vaccine variants showed a similar immune response to those given Shingrix, one month after the second dose. Meanwhile, 12.5% of people injected with the experimental candidate had post-injection reactions such as swelling and redness, lower than the 52.6% people who took GSK's shot. No safety concerns have been identified in the study, the company said. As vaccines are...

New research explores how a vitamin D3 nanoemulsion might help ease the primary symptoms of autism spectrum disorder (ASD) in young children. Many children diagnosed with ASD tend to have low levels of vitamin D3, a deficiency that has been associated with slower development in language, adaptive behaviors, and fine motor coordination. Previous studies on regular vitamin D3 supplements have delivered inconsistent results. In contrast, this study focuses on a nanoemulsion form of vitamin D3, which is specifically designed to improve how well the body absorbs and utilizes the nutrient, potentially leading to more effective outcomes. Study Design and Methodology The study involved 80 children with confirmed ASD diagnoses, all between 3 and 6 years old. These children were randomly split into two groups: one group received the nanoemulsion version of vitamin D3, while the other group was given a commonly available standard supplement. Both groups followed their respective treatments for a six-month period. Researchers evaluated the children’s vitamin D3 levels, social and adaptive behaviors, and language development both before and after the supplementation. To measure these changes, they used widely recognized assessment tools, including the Childhood Autism Rating Scale (CARS), the Vineland Adaptive Behavior Scale, and the Preschool Language Scale. Only the nanoemulsion...

Royalty Pharma has agreed to buy a royalty interest in Amgen's drug for small cell lung cancer from BeOne Medicines for up to $950 million, it said on Monday. Shares of biotech investor Royalty Pharma were up 1.5% in morning trade. The deal gives Royalty Pharma access to roughly 7% of global net sales of the therapy, Imdelltra, which won U.S. approval last year for patients with extensive-stage small cell lung cancer who have failed chemotherapy. Royalty Pharma will pay $885 million upfront, while global cancer drug developer BeOne will retain an option to sell an additional portion for up to $65 million within the next 12 months. BeOne, formerly known as BeiGene and domiciled in Switzerland, will keep the rights to sell the therapy in China. The royalties from the drug are expected to last until between 2038 and 2041. This agreement strengthens Royalty Pharma's portfolio of oncology-related royalty streams, the company said. In 2022, it had bought royalty interests in Roche’s lung cancer drug Gavreto for up to $340 million. Amgen's Imdelltra reduced the risk of death by 40% compared with chemotherapy for small cell lung cancer patients whose disease had worsened after an initial round of chemo, according to interim data in June...

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.

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.”

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.

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,...

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 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...