On the evening of September 28th, Baiyunshan, a listed company under Guangzhou Pharmaceutical Group, and Nanjing Pharmaceutical Co., Ltd. (hereinafter referred to as “Nanjing Pharmaceutical”) announced that Baiyunshan’s Guangzhou Pharmaceutical Phase II Fund Equity Investment Partnership Enterprise (Limited Partnership) (hereinafter referred to as “Guangzhou Pharmaceutical Phase II Fund”) plans to invest 749 million yuan to acquire 145 million non restricted shares of Nanjing Pharmaceutical held by Alliance Healthcare Asia Pacific Limited (“AHAPL”), accounting for 11.04% of the total shares of Nanjing Pharmaceutical. After the acquisition is completed, Guangzhou Pharmaceutical Phase II Fund will become the second largest shareholder of Nanjing Pharmaceutical. According to the announcement, on September 26th, Guangzhou Pharmaceutical Phase II Fund signed a share transfer contract with AHAPL. The buyer and seller agreed to use the arithmetic mean of the daily closing prices of the target company for the 60 trading days prior to the signing date ...
People whose fathers smoked during puberty seem to age faster than expected, according to research presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands. The researchers found signs of faster biological ageing, compared to chronological age, in people whose fathers began smoking at age 15 or younger. They say smoking during puberty may create damage in boys’ developing sperm cells that can be passed on to their children. The researchers call for stronger efforts to prevent tobacco use in teenagers, not only to benefit the current generation but also future generations. The study was presented by Dr Juan Pablo López-Cervantes from the University of Bergen, Norway. He said: “Our research group has previously shown that smoking during puberty may harm not only the person who smokes, but also their future children. In this new study, we wanted to explore whether parental smoking in puberty may also influence ...
Children with asthma who use at-home monitoring are around half as likely to visit the emergency department or be hospitalized, compared to those who only receive care from their medical team, according to research presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands. Remote monitoring also helped keep children’s symptoms under control. At-home monitoring involved children and their families using an app approximately once a month to answer questions about asthma symptoms or track their lung function. The app also contains asthma action and treatment plans, and information on prescribed medications and instructions on how to use them. At-home monitoring is used to reduce in-person outpatient visits when children have stable asthma symptoms. The research was presented by Dr Martinus Oppelaar from Amalia Children’s Hospital, Radboud University Center, Nijmegen, the Netherlands. He told the Congress: “Our team has previously run a successful clinical trial where we showed ...
Drugdu.com expert’s response: The materials required for applying for a medical device registration certificate cover multiple aspects, including enterprise qualifications, product technology, quality control, clinical evaluation, and compliance declarations. The specifics are as follows: Application Form: Fill out the Medical Device Registration Application Form, ensuring that the information is accurate and complete. It should cover basic product information, the registration applicant, and the intended use of the product, among other details. Proof Documents: Copies of the business license and organization code certificate (newly registered enterprises may use the unified social credit code instead and may not need to provide the organization code certificate separately) to prove the legal operation of the enterprise. Identity proofs and copies of educational or professional qualification certificates for the legal representative, enterprise leader, and quality leader to confirm the identities and qualifications of key enterprise personnel. A list of technical personnel along with copies of ...
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 ...
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 ...
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 ...
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 ...
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: ...
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 ...
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