PharmaFocus Today – Page 5 – media

These 4 new drugs have no American subjects, but are listed in the United States

As global drug research and development enters a period of clinical globalization and diversified approval pathways, how drug regulatory agencies evaluate and accept data from different sources is no longer just a matter of technical judgment, but also involves institutional mutual trust, geopolitics, and even the reshaping of the industrial landscape. According to the FDA’s “Drug Trials Snapshots 2024” report, the FDA approved four drugs in 2024 without any U.S. subjects involved. This rare move was widely interpreted as the FDA’s loosening of its stance on global data sources under certain conditions. Zero American Subjects: Analyzing Trend Changes from Individual Cases In 2024, the FDA approved 50 new drugs, four of which did not include any U.S. subjects at all. The four drugs are: EXBLIFEP (drug for complicated urinary tract infections), PIASKY (a rare disease treatment for paroxysmal nocturnal hemoglobinuria), TEVIMBRA (a PD-1 drug for esophageal cancer), and UNLOXCYT (for ...
- Source: drugdu
- 46
- August 5, 2025
Weight Loss Diet Not Needed With Exercise for Hip OA Pain

A very-low-calorie diet and weight loss combined with exercise does not appear to offer any greater reductions in hip osteoarthritis (OA) pain compared to exercise alone, even in people who are overweight or obese. Overweight and obesity are considered risk factors for hip OA, yet there are conflicting data on whether weight loss reduces the need for hip joint replacement, researchers wrote in their August 4, 2025, report published in Annals of Internal Medicine. In this study, researchers randomly assigned 101 people in Australia with a BMI above 27 to either 1) a dietitian-supported ketogenic very low-calorie diet plus a home-based exercise program supported by regular physiotherapy consultations or 2) the exercise program alone for 6 months. All the participants were aged 50 years or older, had experienced significant hip pain for at least 3 months, and had radiographic evidence of femoral or acetabular osteophytes and joint space narrowing. Despite ...
- Source: drugdu
- 44
- August 5, 2025
A Saliva-Based Test for Breast Cancer Might Be Near

By Ernie Mundell HealthDay ReporterMONDAY, Aug. 4, 2025 (HealthDay News) — In a small new study, a handheld saliva-sampling device successfully detected breast cancer 100% of the time, researchers said. The study only involved 29 saliva samples, and more research is needed. However, the results remain “very exciting because this device could improve access to breast cancer screening and significantly reduce health care costs,” said study co-author Dr. Coy Heldermon, a breast oncologist at University of Florida Health in Gainesville. “If all holds true, it would be a game-changer,” he said in a university news release. Access to screening remains a barrier to spotting breast cancers early, when they are most amenable to treatment. The American Cancer Society currently recommends that average-risk women get their first mammogram at age 40, and an MRI if they have specific risk factors, such as a family history of the disease. Of course, mammograms ...
- Source: drugdu
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- August 5, 2025
FDA Approves of VIZZ Eye Drops to Treat Presbyopia

The FDA has approved VIZZ eye drops (LENZ Therapeutics, Inc.) for the treatment of presbyopia, the gradual loss of near vision associated with aging that affects nearly 130 million American adults. The active ingredient in VIZZ 1.44% drops is aceclidine, an FDA approved product that contracts the sphincter of the iris, resulting in a pinhole effect that extends depth of focus to improve near vision without causing a myopic shift, according to the drug’s manufacturer. The FDA decision “represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States,” said Eef Schimmelpennink, president and CEO of the company, in a statement. The FDA approval followed the results of three randomized controlled phase 3 studies that evaluated the safety and efficacy of VIZZ. CLARITY 1 and CLARITY 2 enrolled 466 participants who received a single daily dose for 42 ...
- Source: drugdu
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- August 4, 2025
Do Millipedes Hold Key to Pain Relief, Parkinson’s Treatment?

By Carole Tanzer Miller HealthDay ReporterSATURDAY, August 2, 2025 (HealthDay News) — To fend off predators, millipedes release defensive compounds that could one day play a part in treating pain and neurological diseases. “These compounds are quite complex, so they’re going to take some time to synthesize in the lab,” said chemist Emily Meyers, whose research specializes in leveraging the chemistry of underexplored ecological sources in the name of drug discovery. She and her Virginia Tech colleagues recently identified complex structures in millipedes’ natural secretions that can influence specific neuroreceptors in ant brains, according to a campus news release. The team published its findings earlier this month in the Journal of the American Chemical Society. The newly discovered compounds are part of a class of naturally occurring alkaloids. The name Meyers’ team gave them — andrognathanols and andrognathines — is a tip of the hat to the millipede on Virginia ...
- Source: drugdu
- 52
- August 4, 2025
Humanwell Pharmaceuticals and JD.com hold talks on full-link cooperation in the pharmaceutical field

July 28th, the Industrial Development Department/Business Collaboration Department of China Merchants Group and China Merchants Innovation and Technology jointly organized Renfu PharmaceuticalA delegation visited JD.comAt the group headquarters, talks were held with JD Government and Enterprise, JD Health , and JD Logistics teams on deepening cooperation across the entire pharmaceutical chain. At the meeting, core business units of Renmin Pharmaceutical , including Yichang Renmin, Xinjiang Uyghur Medicine, Gedian Renmin, Renmin Puke, Yichang Three Gorges Pharmaceutical, and Wuhan Tianrun, focused on the core demands of e-commerce development and proposed cooperation directions. The JD team responded positively, stating that it will integrate on-site marketing resources, optimize operational docking, open data support, and provide assistance in logistics technology, channel management, and vertical platform construction (such as ethnic medicine halls and pet pharmacies). https://finance.eastmoney.com/a/202508033474553678.html
- Source: drugdu
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- August 4, 2025
Hybio Pharmaceuticals and KuCoin have reached a strategic cooperation to explore the innovative drug RWA project

According to Hybio Pharmaceutical, on August 4, Hybio Pharmaceutical and digital asset platform KuCoin officially signed a letter of intent for strategic cooperation. The two parties intend to jointly explore and promote the first ” innovative drug” in mainland China in Hong Kong. This is a pilot project for tokenizing RWA (Real World Asset) with the future income rights of R&D as the underlying asset. According to the agreement, Hybio Pharmaceutical will use its technology accumulation and R&D pipeline in the field of GLP-1 peptide blockbuster drugs as the underlying asset, and KuCoin will leverage its blockchain The advantages in technology, RWA full-process solutions and global compliance resources provide the project with integrated support for on-chain mapping, asset tokenization, transaction matching, and profit distribution. https://finance.eastmoney.com/a/202508043475115419.html
- Source: drugdu
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- August 4, 2025
China’s first! China’s CAR-T has a new addition

The NMPA official website shows that the Class 1 innovative biological product independently developed by Hengrun Dasheng, Renikiolunsai Injection (trade name: Hengkailai), has been approved for marketing in China . As China’s first fully independently developed CD19 CAR-T product for relapsed or refractory large B-cell lymphoma (r/r LBCL), its approval not only fills the gap in China’s CAR-T field, but also marks that China’s immune cell therapy technology has entered a new stage of independent control. The approval of Renykiolencil Injection was based on its excellent performance in clinical trials. In the Phase II HRAIN01-NHL01-II study, the drug enrolled 81 patients with relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL) who had received at least two lines of therapy (including an anthracycline and a CD20-targeted drug) or autologous hematopoietic stem cell transplantation. Study results showed that Renykiolensay injection not only demonstrated a durable remission effect in patients with relapsed or refractory large B-cell ...
- Source: drugdu
- 47
- August 4, 2025
Profits soared 47 times as Hebo Pharmaceuticals continued its offensive

Recently, Hebo Pharmaceuticals released a positive earnings forecast: it expects profits of US$68 million (approximately HK$532 million) to US$74 million (approximately HK$579 million) in the first half of 2025. This figure represents a more than 47-fold increase from approximately US$1.4 million in the same period of 2024, and easily exceeds its projected full-year profit of US$2.778 million in 2024. Its profit growth mainly comes from BD cooperation income, of which the initial payment, milestone payment and option payment from AstraZeneca accounted for US$175 million. Since Harbour BioMed successfully turned a profit in 2023 through licensing revenue, the market has questioned the sustainability of this model. However, Harbour BioMed’s continued strong performance has proven that BD revenue can be converted into a stable and regular revenue stream, exploring a new path for innovative pharmaceutical companies to survive. Billions of BD orders ignited the performance explosion point As early as 2020, Hebo ...
- Source: drugdu
- 42
- August 4, 2025
Several of the company’s products have obtained medical device registration certificates

On July 30, the company announced that it had recently received a medical device certificate issued by the Henan Provincial Drug Administration.The company has obtained registration certificates for a total IgE test kit, a β2-microglobulin test kit, a specific IgE antibody calibration kit, an aldosterone test kit, a dust mite allergen-specific IgE antibody test kit, and an artemisia allergen-specific IgE antibody test kit. These registration certificates enrich the company’s product portfolio and enhance its competitiveness, but will have a minimal impact on short-term operating performance. Post-launch sales of these products depend on the effectiveness of market promotion, and the impact on future operating income is currently unpredictable. Source：https://finance.eastmoney.com/a/202507303471485410.html
- Source: drugdu
- 44
- August 3, 2025

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