PharmaFocus Today – Page 51 – media

FDA Urges Safe Use of Hyperbaric Oxygen Therapy Devices

By Stephanie Brown HealthDay ReporterWEDNESDAY, Aug. 27, 2025 (HealthDay News) — The U.S. Food and Drug Administration has sent letters to health care providers alerting them to the importance of following manufacturer instructions for the safe use of hyperbaric oxygen therapy (HBOT) devices. HBOT uses a pressurized chamber to deliver 100 percent oxygen, helping the lungs absorb more oxygen to support healing and fight infections, according to the FDA. The agency has recently received reports of fires with HBOT devices causing serious injuries and deaths. Though rare, these events highlight the importance of following manufacturer instructions to reduce risks, the FDA notes. The agency advises health care providers to follow strict fire prevention and safety measures with HBOT devices, including proper grounding. Staff working with HBOT devices should receive ongoing training and always keep in mind that high concentrations of oxygen increase the risk for fire. Patients need to be ...
- Source: drugdu
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- August 28, 2025
Telpotide will surpass semaglutide in all aspects, and it will be around next year

If the GLP-1 drug battle between Novo Nordisk and Eli Lilly were a football match, then 2021-2025 would be the first half, with Novo Nordisk’s earlier launches giving Eli Lilly’s product a head start. However, the situation seems poised to reverse in the second half, which begins in 2026. In 2026, we will achieve comprehensive transcendence According to Bloomberg’s forecast, Mounjaro and Zepbound will surpass Ozempic and Wegovy in 2026, and the gap will widen significantly in the next three years (Figure 1). Figure 1 Historical sales and future sales forecast trends of Wegovy, Ozempic, Mounjaro, and Zepbound Image source: Bloomberg In 2025, Novo’s semaglutide combination (Ozempic + Wegovy) will have a total revenue of US$33.6 billion, still higher than Lilly’s tirzepatide combination (Mounjaro + Zepbound) of US$31.1 billion; by 2026, the positions will be reversed, with Eli Lilly’s tirzepatide products totaling US$40.8 billion, ahead of Novo Nordisk’s semaglutide of ...
- Source: drugdu
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- August 28, 2025
Hengrui Medicine receives approval for clinical trials of HRS-6093 tablets, with a R&D investment of 29.84 million yuan

On August 25, Hengrui Medicine (600276/01276) issued an announcement that the company recently received the “Drug Clinical Trial Approval Notice” for HRS-6093 tablets approved and issued by the National Medical Products Administration, and will conduct clinical trials in the near future. This drug is a novel, highly potent, and selective oral KRASG12D inhibitor that specifically binds to the mutant KRASG12D protein, exerting anti-tumor effects. Currently, no similar products have been approved for marketing in China or abroad. To date, the cumulative R&D investment in the HRS-6093 tablet project has reached approximately 29.84 million yuan. According to the relevant laws and regulations on drug registration, after obtaining approval for clinical trials, drugs still need to undergo clinical trials and be reviewed and approved by the National Medical Products Administration before they can be produced and marketed. There is uncertainty in the drug research and development and marketing process. By mid-2025, Hengrui ...
- Source: drugdu
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- August 28, 2025
HPV vaccine sales fell short of expectations, with Wantai Biopharma turning profit into loss in the first half of the year

Recently, Wantai BioThe company disclosed its 2025 semi-annual report, showing that its operating income in the first half of the year was 844 million yuan, a year-on-year decrease of 38.25%; its net profit attributable to shareholders of the parent company turned from profit to loss to -144 million yuan, a year-on-year decrease of 155.3%; its non-net profit was as low as -243 million yuan, a year-on-year decrease of 481.93%. Regarding the decline in revenue and net profit, Wantai Biological explained that it was mainly due to the fact that the company’s vaccine segment was affected by market adjustments, government procurement and the expansion of the age limit for the nine-valent HPV vaccine, resulting in sales falling short of expectations and a decline in revenue from the vaccine segment compared with the same period last year. Regarding the company’s sharp decline in first-half performance and subsequent boosting measures, a reporter from ...
- Source: drugdu
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- August 28, 2025
Lepu Medical’s subsidiary completes first dose in Phase II clinical trial of innovative drug MWN109

On August 25, Lepu Medical(300003) announced that its holding subsidiary, Minwei Bio, independently developed an innovative drugMWN109 injection is currently undergoing Phase II clinical trials for the treatment of overweight or obesity, and the first subject was successfully dosed recently. The drug is a GLP-1/GIP/GCG receptor triple agonist with global intellectual property rights .MWN109 injection is designed to effectively control blood sugar and reduce weight by stimulating pancreatic beta cells to secrete insulin and increase satiety. MWN109 injection received clinical trial approval from the National Medical Products Administration in November 2024. A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial has been initiated, primarily investigating the effectiveness of different doses of MWN109 injection in reducing weight over a 24-week period in non-diabetic overweight or obese participants. The primary endpoint of the study is the percentage change in body weight compared to baseline after 24 weeks of dosing. The company reminds ...
- Source: drugdu
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- August 28, 2025
Sinovac expands into trauma field; adsorbed tetanus vaccine receives drug registration approval

China Business Network reported on August 27 that on August 25, the adsorbed tetanus vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd., a subsidiary of Beijing Kexing Holdings (Group) Co., Ltd., obtained the “Drug Registration Certificate” issued by the National Medical Products Administration (Approval Number: National Medicine Standard S20250048), which will provide more options for tetanus prevention. Sinovac’s adsorbed tetanus vaccine uses an aluminum hydroxide adjuvant with a particle size of only 300 nanometers (compared to traditional adjuvants of 1-10 microns), which improves antigen adsorption efficiency and significantly enhances formulation stability. By upgrading the purification process, the tetanus vaccine concentrate has better immunogenicity. According to the “Guidelines for the Diagnosis and Treatment of Non-Neonatal Tetanus (2024 Edition)”, tetanus remains a serious public health problem in countries and regions where immunization programs are not fully implemented. It is estimated that there are approximately 1 million cases of tetanus and 300,000 ...
- Source: drugdu
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- August 27, 2025
Gilead expands its cell therapy portfolio

Recently, Kite, a subsidiary of Gilead, announced that it will acquire the biotechnology company Interius BioTherapeutics for US$350 million in cash. This strategic layout marks Gilead’s opening up of a new frontier in the field of cell therapy. Cell therapy, a frontier of innovation in the biopharmaceutical field, is developing at an astonishing pace. While traditional CAR-T therapy has achieved remarkable results in treating hematologic malignancies, it is limited by complex procedures and high costs. Kite’s acquisition of Interius is driven by its pioneering work in in vivo CAR-T therapy. Interius’s in vivo CAR-T technology innovatively eliminates the tedious in vitro steps of traditional therapies, opening up new avenues for the convenience and accessibility of cell therapy and injecting strong technological vitality into Gilead. Interius’s technology platform, leveraging its modularity, can be efficiently adapted to diverse disease areas, enabling scalable production. INT2104, the lead product in its R&D pipeline, is ...
- Source: drugdu
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- August 27, 2025
Tariffs on medicines will be imposed soon

On August 25, local time, it was reported that US President Trump said that he would reduce drug prices to 1/1400 to 1/1500 of the current price, and would deal with the cost figures of US drug prices. Tariffs on medicines will soon be imposed. https://finance.eastmoney.com/a/202508263494050365.html
- Source: drugdu
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- August 27, 2025
my country’s pharmaceutical industry ranks second in the world

Yang Sheng, deputy director of the National Medical Products Administration, recently stated that China’s pharmaceutical industry is currently ranked second in the world, with innovative drugsThe number of projects under research accounts for about 30% of the world’s total. Yang Sheng said that to complete the goals and tasks of the 14th Five-Year Plan with high quality and ensure the safety and effectiveness of people’s use of medicines, work should be mainly carried out in three aspects: comprehensively strengthening the bottom line of drug safety, supporting the high-quality development of the pharmaceutical industry throughout the entire chain, and fully guaranteeing the people’s drug needs. In terms of building a solid bottom line for drug safety in all aspects, my country has strengthened dynamic supervision covering the entire life cycle of drugs, established and improved a drug safety risk consultation mechanism, focused on key links such as online drug sales, contract ...
- Source: drugdu
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- August 27, 2025
Novartis, BioArctic Reach Deal to Develop BrainTransporter Therapy for Neurodegeneration

Novartis and BioArctic AB have entered into an option, collaboration, and license agreement to explore a potential new treatment for neurodegenerative disorders. The partnership will apply BioArctic’s proprietary BrainTransporter technology to enhance brain-targeted delivery of therapeutic agents, with the goal of generating a novel drug candidate for evaluation in preclinical and early research stages. How does the Novartis agreement expand BioArctic’s BrainTransporter strategy? Under terms of the deal, BioArctic will receive an upfront payment of $30 million during the initial research collaboration, during which it will generate a drug candidate combining BrainTransporter with a Novartis proprietary antibody. After reviewing the resulting data, Novartis may exercise an option to license the candidate, a step that would trigger additional potential payments to BioArctic of up to $772 million. The Swedish biotech would also be eligible for tiered mid–single-digit royalties on any eventual global product sales. If Novartis chooses to exercise the option, ...
- Source: drugdu
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- August 27, 2025

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