The next-generation weight loss drug developed by Metsera, Inc. in the United States has shown good tolerability in an interim clinical trial, with only a very small number of participants dropping out midway, a result that has increased the attractiveness of the pharmaceutical company. Studies show that the drug’s weight loss effect is comparable to that of current market leader Eli Lilly.It is comparable to Zepbound, and only about 3% of participants dropped out of the trial. In contrast, some other weight-loss drugs…The dropout rate in the trial was high, with participants often discontinuing the medication due to side effects. John Buse, a professor at the University of North Carolina at Chapel Hill School of Medicine, said while introducing the trial at the Obesity Society Annual Meeting in Atlanta, “The tolerability (of the drug) is excellent.” Metsera first disclosed trial data at the end of September. The results showed that ...
Researchers at the University of California San Diego have found that an intensive retreat combining multiple mind-body techniques, including meditation and healing practices, produced rapid and wide-ranging changes in brain function and blood biology. The researchers found that the retreat engaged natural physiological pathways promoting neuroplasticity, metabolism, immunity and pain relief. The findings, published in Communications Biology, provide insights into how consciousness and psychological practices can enhance physical health. Meditation and other mind-body practices have been utilized by cultures worldwide for thousands of years to promote health and wellness; however, the underlying biology of these approaches remains poorly understood. The new study, part of a multi-million-dollar research initiative supported by the InnerScience Research Fund, is the first to comprehensively quantify the biological effects of multiple mind-body techniques administered together over a short period. “We’ve known for years that practices like meditation can influence health, but what’s striking is that combining ...
Associated Press (AP) — U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles. The Food and Drug Administration said it was taking action after receiving reports of injuries in connection with the products, including toxic side effects. Botox is a diluted, purified form of botulinum, one of the most toxic substances in the world. The ingredient works by temporarily blocking nerve signals and causing muscles to relax. While most famously approved for cosmetic use, Botox is also approved in the U.S. for a number of medical conditions, including muscle spasms, eye disorders and migraines. The FDA warning letters mostly went to cosmetic websites. In each case, the FDA said the companies were offering unofficial or mislabeled versions of Botox-like drugs that haven’t been approved by the agency. In addition to the original ...
Chiesi Group is very young. Compared to multinational pharmaceutical giants that entered China in the last century, Casey only entered the Chinese market for the first time in 2001 through a partner. Kathy was still a minor in China when she established her consulting firm in Shanghai in 2008, which is considered her “birthday”. Casey is not young either. This international pharmaceutical group, headquartered in Parma, Italy, is a 90-year-old “veteran” in the industry, with business covering 31 countries and regions around the world. This is very similar to Marco Polo, who was also Italian—born into the long-established Venetian Polo merchant family, he was also a minor when he set off for China with his father and uncle. Perhaps seeing this coincidence, Casey Group simply called its China market strategy the “Marco Polo Project”. Marco Polo shared his experiences in China with Europe, igniting a fervent fascination with the East ...
Beijing Business Daily (Reporter Wang Yinhao and Song Yuying) – On November 6th, Shanghai Pharmaceuticals…The company announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., received a notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (US Generic Drug Application) for ticagrelor tablets has been finally approved for marketing. The announcement indicates that ticagrelor tablets are used for patients with acute coronary syndrome, including those receiving drug therapy and percutaneous coronary intervention, to reduce the incidence of thrombotic cardiovascular events. The original drug was launched in the United States in 2011. https://finance.eastmoney.com/a/202511063557185324.html
SecuritiesDaily News Network: Zhong Sheng PharmaceuticalIn response to investor inquiries on an interactive platform on November 6, the company stated that its RAY1225 injection has global independent intellectual property rights.This innovative structural peptide drug possesses dual agonist activity against both GLP-1 and GIP receptors. Benefiting from its excellent pharmacokinetic properties, it has the potential to be an ultra-long-acting drug requiring injection every two weeks. Clinically, it is intended for the treatment of type 2 diabetes and obesity/overweight patients, and is currently in Phase III clinical trials. Furthermore, RAY1225 injection has received a Notification of Approval for Clinical Trials from the U.S. Food and Drug Administration (FDA), authorizing the direct commencement of Phase II clinical trials in the United States for the indication of overweight or obesity. https://finance.eastmoney.com/a/202511063557320356.html
Humanwell Healthcare(600079) announced on November 6th that its wholly-owned subsidiary, Hubei Biomedical Industry Technology Research Institute Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” for HWH217 tablets issued by the National Medical Products Administration. HWH217 tablets are a new compound preparation containing known active ingredients, classified as a Class 2.3 chemical drug, and are intended for the treatment of (WHO Group 1) arterial pulmonary hypertension. According to Insight database statistics, there are currently no compound preparations approved for marketing in China for this indication. To date, the cumulative R&D investment in this project is approximately RMB 6 million. https://finance.eastmoney.com/a/202511063557058041.html
Drugdu.com expert’s response: The medical device industry is subject to a multi-tiered regulatory framework of laws and regulations and standards at both domestic and international levels, covering the entire product lifecycle management. The following provides an explanation from four perspectives: legal framework, international standards, domestic regulations, and key compliance considerations. I. Legal Framework: Global and Regional Core Regulations China’s Regulations on the Supervision and Administration of Medical Devices Core Positioning: The “basic law” for medical device supervision, clarifying classification management, registration/filing, production/operation/usage requirements, and legal liabilities. Key Provisions: Classification Rules: Products are categorized into Class I, II, and III based on risk levels, with differentiated regulatory oversight (e.g., stringent approval for Class III). Registration and Filing: Class I devices undergo filing management, while Class II and III devices require technical evaluation and system verification, along with submission of clinical evaluation data (some Class II devices may be exempted). Unique Device Identification ...
On November 5, MICO Pharmaceutical (688373) issued an announcement stating that the company recently received the “Approval Notice for Supplementary Application for Drug” and the “Approval Notice for Supplementary Application for Drug Clinical Trial” issued by the National Medical Products Administration. The announcement stated that Jiangsu Xuantai Pharmaceutical Co., Ltd. has been approved as a new contract manufacturer for continazolamide tablets, while Chongqing Boteng Pharmaceutical Technology Co., Ltd. will serve as its active pharmaceutical ingredient supplier. Continazolamide tablets are a new generation of oxazolidinone antibacterial drug used to treat complicated skin and soft tissue infections. The product was approved for marketing in China in June 2021. In addition, the announcement also mentioned that the supplemental application for clinical trials of MRX-5 tablets has been approved, allowing for the addition of a 200mg dosage for clinical trials. MRX-5 is a novel benzoborazole antibiotic intended for the treatment of infections caused by ...
Beijing News (Reporter Wang Kala) November 4, Merck…The company announced a $700 million R&D funding agreement with Blackstone, which will be used for the global development of its core ADC asset, sacubitril-TMT (sac-TMT). At a time when the ADC field is becoming a global focus of pharmaceutical innovation , this collaboration between a multinational pharmaceutical company and a capital giant not only demonstrates a high level of recognition of the commercial value of sacubitril-TMT, but also signifies a major milestone for innovative drugs in China.Driven by a dual approach of “global R&D + capital empowerment,” it is accelerating its entry into the ranks of global blockbuster drugs. Under the terms of the agreement, Blackstone will pay Merck $700 million specifically to fund a portion of the development costs for SAC-TMT projected to be incurred in 2026. Merck stated that this agreement will help the company fully realize the potential of ...
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