PharmaFocus Today – Page 43 – media

Zhifei Bio’s subsidiary’s vaccine application for clinical trial accepted

On August 18, Zhifei Bio(300122) issued an announcement that the adsorbed acellular diphtheria, tetanus and pertussis (component) combined vaccine (for adults and adolescents) developed by the company’s wholly-owned subsidiary Zhifei Green Bamboo recently obtained the National Medical Products Administration’s drug clinical trial application acceptance notice. This vaccine is a combination vaccine targeting pertussis (whooping cough), diphtheria, and tetanus, and is suitable for healthy individuals aged seven years and above. Currently, no component DTP vaccine has been approved for use in adolescents and adults in China, and the market prospects are promising. The announcement noted that the acceptance of the clinical trial application for the adolescent and adult diphtheria, pertussis, and tetanus vaccine is the result of the company’s technological innovation and scientific research. If the project progresses smoothly, it will further strengthen the company’s market competitiveness, enrich its product portfolio, and enhance profitability. The company reminds investors that drug development ...
- Source: drugdu
- 172
- August 20, 2025
Seven blood metabolites associated with excessive daytime sleepiness

Mass General Brigham researchers identified seven molecules in the blood linked to excessive daytime sleepiness, including factors related to diet and hormones. Approximately one in three Americans reports experiencing overwhelming drowsiness during the day-a condition known as excessive daytime sleepiness (EDS). EDS is linked to an increased risk of serious conditions such as cardiovascular disease, obesity, and diabetes. A new study led by investigators from Mass General Brigham and Beth Israel Deaconess Medical Center identifies several molecules in the blood, known as metabolites, that are linked to EDS. Findings suggest that risk of the condition may be influenced by both internal body processes, such as hormone levels, and external factors such as diet. Results are published in Lancet eBioMedicine. “Our study suggests diet and genetics may play an important role in EDS. As we learn what’s happening biologically, we are beginning to understand how and why EDS occurs, the early ...
- Source: drugdu
- 138
- August 20, 2025
Acetaminophen Linked To Autism/ADHD, Evidence Review Argues

By Dennis Thompson HealthDay ReporterTUESDAY, Aug. 19, 2024 (HealthDay News) — Taking acetaminophen while pregnant might increase a child’s risk of autism or ADHD, a new evidence review says. Analysis of 46 prior studies involving more than 100,000 participants found “strong evidence” that prenatal exposure to acetaminophen could increase the risk of developmental brain disorders like autism and ADHD, researchers reported Aug. 13 in the journal BMC Environmental Health. “Our findings show that higher-quality studies are more likely to show a link between prenatal acetaminophen exposure and increased risks of autism and ADHD,” said lead researcher Diddier Prada, an assistant professor of population health science and policy at the Icahn School of Medicine at Mount Sinai in New York City. This potential link could explain the ongoing surge in developmental disorders among children, the research team said. “As acetaminophen has become the recommended pain reliever for pregnant mothers, the rates ...
- Source: drugdu
- 150
- August 20, 2025
Tianfeng Securities has given Oulin Bio an “buy” rating. The supply of tetanus vaccine continues to increase, and the Staphylococcus aureus vaccine is about to enter the harvest period

Tianfeng Securities released a research report on August 18th, giving Oulin Bio (688319.SH, latest price: 23.99 yuan) an “overweight” rating. The main reasons for the rating include: 1) The adsorbed tetanus vaccine has been continuously increasing in supply, and the market size has gradually expanded; 2) The research and development progress of Staphylococcus aureus vaccine is leading globally, and the future market prospects are broad. 3) The Helicobacter pylori vaccine has obtained the approval for Phase 1 clinical trials in Australia. Risk Warning: Risk of R&D investment, risk of failure in the development of in-progress products, risk of commercialization not meeting expectations, risk of leakage of core technologies, risk of stock price fluctuations.
- Source: drugdu
- 90
- August 19, 2025
The clinical trial of the trivalent influenza vaccine jointly applied for by Kangtai Biological and Bailing Biological has been approved

On August 18th, Kangtai Biological (300601) issued an announcement, stating that the trivalent influenza virus split vaccine (MDCK cells) jointly applied for by it and Lanzhou Bailing Biotechnology Co., Ltd. has been approved by the relevant review for drug registration, allowing clinical trials to be conducted in people aged 3 and above. This clinical trial will include Phase I and Phase III randomized, blinded, positive-controlled studies, mainly evaluating the safety and immunogenicity of the vaccine. The announcement mentioned that the clinical trial can only be carried out after the three batches of finished products and the various types of the original liquid have been verified as qualified. Meanwhile, the company needs to improve the relevant production processes to ensure that the safety risks of clinical trial samples are controlled within a reasonable range. The announcement also emphasized multiple research areas that need to be focused on during clinical trials, including ...
- Source: drugdu
- 159
- August 19, 2025
Have small molecule weight loss drugs reached their limit?

GLP-1 receptor agonists have garnered widespread attention due to their significant weight loss and diabetes treatment effects. However, despite the remarkable success of existing GLP-1 drugs, many pharmaceutical companies, including Novo Nordisk and Eli Lilly, already established leaders in the weight loss drug market, continue to seek breakthroughs with new drugs and develop convenient and effective treatment options. After the successful Zepbound, which brought endless wealth, Eli Lilly has set its sights on the small molecule asset orforglipron as its next breakthrough, hoping to provide an oral alternative to treat obesity and diabetes. All-round emergency Although orforglipron showed promising results in early clinical trials, especially achieving 15% weight loss in the short term, this effect dropped significantly after entering late-stage trials, to only 11.2%. In comparison, existing injectable GLP-1 drugs (such as Wegovy and Zepbound) demonstrate weight loss effects ranging from 15% to 21%, respectively. This significant disparity presents orforglipron ...
- Source: drugdu
- 88
- August 19, 2025
FDA Approves Tonix Pharmaceuticals’ Tonmya for Fibromyalgia

The FDA has approved Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, marking the first new therapy approved for this condition in over 15 years. The approval was based on results from the Phase III RELIEF (NCT04172831) and RESILIENT (NCT05273749) trials, which demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at week 14.1 What makes Tonmya a Breakthrough Option for Fibromyalgia Patients? “The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US suffering from the debilitating pain this condition causes,” said Seth Lederman, MD, CEO, Tonix Pharmaceuticals, in a press release. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years. We are hopeful that effectively treating pain ...
- Source: drugdu
- 164
- August 19, 2025
Automatic Health Stations Easy Way To Check For Heart Health Risks

By Dennis Thompson HealthDay ReporterMONDAY, Aug. 18, 2025 (HealthDay News) — Everyone’s seen the automatic blood pressure reader wedged unobtrusively into a corner of their local pharmacy. These sit-down machines can pay huge dividends when it comes to helping people learn their heart health risks, a new study says. Setting up these health stations at community pharmacies – and one international sporting event – led to nearly 7 in 10 young adults learning they had one or more uncontrolled risk factors for heart disease, researchers reported Aug. 15 in the Journal of the American College of Cardiology. “Heart health checks in the community can identify risk factors for future heart disease that can be managed by lifestyle changes or early preventive medications and save lives down the road,” said senior researcher Stephen Nicholls, director of the Victorian Heart Institute at Monash University in Victoria, Australia. “We saw in this study ...
- Source: drugdu
- 91
- August 19, 2025
Pioneering Helicobacter pylori new drug faces commercialization challenge

Recently, Dannuo Pharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as Dannuo Pharmaceutical) submitted a prospectus to the Hong Kong Stock Exchange, intending to list on the main board, which immediately attracted high attention from the capital market. Dano Pharmaceuticals’ new Helicobacter pylori drug, Leflunomide (TNP-2198), is experiencing a thrilling leap before commercialization – this world’s first differentiated antibiotic, which has advanced to the Phase III clinical endpoint, is regarded as the “hope of the whole village” by the company, but also carries the triple test of solving the drug resistance dilemma, overcoming medical insurance barriers, and increasing sales volume. As a potential solution for 44% of the infected population in China, the clinical value of levofloxacin and the 775 million yuan commercial betting agreement ignite capital imagination; But Dano Pharmaceuticals’ 530% debt ratio and cash flow crisis have made the market closely monitor every move in its August NDA submission ...
- Source: drugdu
- 113
- August 19, 2025
Doctors Seek Best Way to Treat Newly Discovered Genetic Disorder

By Carole Tanzer Miller HealthDay ReporterSATURDAY, Aug. 16, 2025 (HealthDay News) — Most folks probably think of gene mutations as something people are born with, but genes can also change later in life, sometimes making people sick. Scientists recently discovered a new disease that starts just that way in midlife. Called VEXAS, it’s marked by repeated attacks of inflammation caused by an immune system that goes rogue and attacks its own cells. “Part of normal aging is that all our cells develop mutations,” Dr. David Beck, a New York University geneticist who was part of the team that discovered VEXAS, told NIH News in Health. “It’s just normal wear and tear on our cells as we get older.” The type of mutation that causes VEXAS — known as an acquired mutation — is not passed on from parent to child. Acquired mutations develop, instead, over a lifetime, and exposure to ...
- Source: drugdu
- 93
- August 18, 2025

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