media – Page 24 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Gene Therapy Slows Huntington’s Disease in Early Trial

FRIDAY, Sept. 26, 2025 (HealthDay News) — A new gene therapy has shown promise in slowing the progression of Huntington’s disease, according to early trial results released Wednesday. In a Phase 1/2 study, patients given a high dose of UniQure’s experimental therapy AMT-130 experienced a 75% slowing of disease progression after three years, the company said. The therapy also reduced levels of a key marker of brain damage — neurofilament light protein in spinal fluid — by an average of 8.2%. “These findings reinforce our conviction that AMT-130 has the potential to fundamentally transform the treatment landscape for Huntington’s disease,” Dr. Walid Abi-Saab, chief medical officer at UniQure, told CNN. The trial, run in partnership with University College London, included 29 patients treated with either a high or low dose of AMT-130 and followed for 36 months. The treatment was delivered surgically by injecting the therapy directly into the brain’s ...
- Source: drugdu
- 79
- September 28, 2025
Regeneron’s Evkeeza Approved in U.S. for Young Children with Homozygous Familial Hypercholesterolemia

Regeneron announced FDA’s approval of its ANGPTL3 antibody Evkeeza for treatment of homozygous familial hypercholesterolemia (HoFH) in children ages 1 to less than 5-years-old. Evkeeza was initially approved in 2021 for use in adults and children aged 12-and-up, and received approval again in 2023 for use in children aged 5 to 11-years-old. Each of Evkeeza’s approvals were reviewed under Priority Review, a process which is reserved for medications representing potential improvements in either efficiency or safety of treating serious diseases. “The approval of Evkeeza for children as young as 1 year of age addresses a critical unmet need for those with homozygous familial hypercholesterolemia, a life-threatening condition that causes extraordinarily high LDL-C levels from birth,” said Katherine Wilemon, founder and CEO of the Family Heart Foundation. “Families and their medical teams will now have an effective treatment option for these very young children who are at risk of serious complications ...
- Source: drugdu
- 71
- September 28, 2025
There are as many as 330 million cardiovascular patients in China, and we need to be alert to the risk of comorbidities

Currently, the number of cardiovascular disease patients in China is as high as 330 million, including 245 million patients with hypertension and over 10 million patients with coronary heart disease and stroke; Cardiovascular diseases account for nearly 50% of total deaths among residents, ranking first among all types of diseases and being known as the “number one killer” that threatens residents’ health. With the deepening of the “Healthy China 2030” strategy, the prevention and control of cardiovascular and cerebrovascular diseases have been included in the key prevention and control category, and the results have been significant. However, in the context of accelerated aging, the overall prevention and control situation is still grim: on the one hand, the number of cardiovascular disease patients is huge, and the incidence rate continues to rise; On the other hand, middle-aged and elderly patients often face the problem of multiple diseases coexisting, and the “interweaving ...
- Source: drugdu
- 73
- September 28, 2025
The National Healthcare Security Administration has issued 33 batches of project initiation guidelines; Borui Pharmaceutical’s IPO in Hong Kong

The National Medical Insurance Administration carries out the third national video dispatch for the special rectification of prominent issues in the management of medical insurance funds On the morning of September 26th, the National Medical Insurance Administration launched the third national video dispatch of the special rectification work on prominent issues in the management of medical insurance funds, summarizing the progress and effectiveness of the special rectification in the previous stage, and making arrangements for the implementation of the “100 day action”. Deployment requirements: This “100 day action” should focus on prominent illegal and irregular issues in the medical insurance field, closely monitor the three key tasks of reselling medical insurance return drugs, illegally prescribing excessive drugs, and defrauding maternity allowances, carry out concentrated and precise rectification, strictly investigate and crack down in accordance with laws and regulations, and strive to basically eliminate the problem of reselling medical insurance return ...
- Source: drugdu
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- September 28, 2025
【EXPERT Q&A】What regulatory requirements does the EU IVDR have for self-testing and point-of-care testing products?

Drugdu.com expert’s response: The EU In Vitro Diagnostic Regulation (IVDR) imposes comprehensive and stringent regulatory requirements on self-testing and point-of-care testing (POCT) products, covering aspects such as classification management, technical documentation, labeling and instructions, conformity assessment, and post-market surveillance. The specifics are as follows: I. Classification Management: Scientific Risk-Based Grading The IVDR classifies in vitro diagnostic products into four categories—A, B, C, and D—with risk levels increasing sequentially. Self-testing products are typically categorized as Class C, with the following exceptions: Class B Self-Testing Products: Examples include pregnancy tests, ovulation tests, cholesterol detection reagents, and tests for glucose, red blood cells, white blood cells, and bacteria in urine. Class C or D Special Self-Testing Products: Products used to detect sexually transmitted pathogens, blood or tissue typing, or where erroneous results could lead to death or severe disability may be classified as Class C or D. II. Technical Documentation and Performance Evaluation: ...
- Source: drugdu
- 112
- September 26, 2025
CDC Vaccine Advisors Unanimously Vote to Transition from Broad Covid-19 Vaccine Recommendation

On Friday, September 19, 2025, CDC’s vaccine advisors came to a unanimous vote shifting away from broad recommendations for Covid-19 vaccines. According to a report from CNN, the advisors agreed on transferring its recommendation to a process known as shared clinical decision-making, which entails patients consulting a professional healthcare provider before receiving the vaccine. Requiring clinical decision-making “assumes health care and insurance,” said Dr. Demetre Daskalakis, who recently resigned as head of the CDC’s National Center for Immunization and Respiratory Diseases. Daskalakis continued to say, “We do not have universal health care in this country, and we know millions of people are losing insurance.” What was ACIP’s decision on Covid-19 vaccine recommendations? Despite the unanimous vote from CDC’s vaccine advisors, the Advisory Committee on Immunization Practices (ACIP) was split on its recommendation to require prescriptions for Covid-19 vaccines. According to a report from CNN, the vote ended in even split ...
- Source: drugdu
- 108
- September 25, 2025
Fish Oil May Raise or Lower Colon Cancer Risk, Depending on Your Genes

WEDNESDAY, Sept. 24, 2025 (HealthDay News) — About 19 million U.S. adults take fish oil supplements, often to protect against chronic diseases. But new research suggests their ability to lower colon cancer risk may depend on a single gene. Scientists at the University of Michigan and the University of Texas MD Anderson Cancer Center found that the gene 15-lipoxygenase-1 (ALOX15) is critical for omega-3 fatty acids in fish oil (EPA and DHA) to fight colon cancer. The study — recently published in the journal Cellular and Molecular Gastroenterology and Hepatology — showed that without ALOX15, fish oil could actually raise the risk of colon tumors in mice. “Not all fish oil supplements are the same,” senior researcher Imad Shureiqi, professor of internal medicine at the University of Michigan Rogel Cancer Center in Ann Arbor, said in a news release. “It is also important to ask whether the person who is ...
- Source: drugdu
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- September 25, 2025
Obtained drug clinical trial approval notice

On September 24, Jiudian PharmaceuticalThe company announced in the evening that it recently received the “Notice of Approval for Drug Clinical Trial” from the National Medical Products Administration (NMPA). Clinical trials will commence after completing relevant preparatory work. The relevant information is as follows: JIZM01 is indicated for closed soft tissue contusions and joint sprains, while JIZM02 is indicated for periarthritis of the shoulder. Following review, approval has been granted for clinical trials in accordance with the Drug Administration Law of the People’s Republic of China and relevant regulations. https://finance.eastmoney.com/a/202509243522589468.html
- Source: drugdu
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- September 25, 2025
51.9 billion, Pfizer increases investment in GLP-1?

On September 22, according to multiple media reports, global pharmaceutical giant Pfizer is close to completing a major acquisition, and will acquire Metsera, a developer of ultra-long-acting weight loss drugs, for US$7.3 billion (approximately RMB 51.9 billion). This may become one of the important acquisition events in the pharmaceutical field this year. Pfizer plans to pay $47.50 per Metsera share in cash, with an additional $22.50 per share payable if Metsera meets certain performance targets, valuing Metsera at up to $7.3 billion. The acquisition could be announced as early as September 22. Metsera specializes in the research and development of weight loss drugs. Its lead drug, MET-097i, is considered an improvement over the current generation of GLP-1 drugs and is expected to revolutionize the weight loss drug market. Obesity, a chronic disease with a steadily increasing incidence in recent years, presents a significant market demand, while existing treatment options are ...
- Source: drugdu
- 96
- September 25, 2025
Gan & Lee Pharmaceuticals signed a supply framework agreement worth over 3 billion yuan with a local Brazilian company

Shanghai Securities News China SecuritiesGanli PharmaceuticalsOn September 24th, the company announced that it had signed a Technology Transfer and Supply Agreement with Fundao Oswaldo Cruz-Bio-Manguinhos (FZ), a public laboratory under the Brazilian Ministry of Health, and BIOMM SA (BIOMM), a Brazilian biopharmaceutical company. The company also signed a Supply Framework Agreement with BIOMM. According to the announcement, the contract value of the Supply Framework Agreement is expected to be no less than RMB 3 billion, with a term of 10 years. This collaboration is centered around Brazil’s Production Development Partnership Program (Parcerias para oDesenvolvimento Produtivo, or PDP). A key initiative of Brazil’s national public health system, the program aims to promote local pharmaceutical production through technology transfer from multinational pharmaceutical companies, ensuring a long-term, stable supply of essential medicines in Brazil. As early as 2014, Gan & Lee Pharmaceuticals and BIOMM established a comprehensive and in-depth partnership, introducing their superior ...
- Source: drugdu
- 97
- September 25, 2025

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