On July 4, 2024, Sinopharm’s application for marketing authorization of quadrivalent recombinant human papillomavirus vaccine (type 6, 11, 16, 18) (Hansenula polymorpha), which was jointly declared by Sinopharm’s Chengdu Institute of Biological Products of China Biological and China Academy of Biological Sciences (National Engineering Research Center for Novel Vaccines), was accepted by the State Drug Administration under acceptance No. CXSS2400063, the first domestic quadrivalent HPV vaccine in China. This is the first quadrivalent HPV vaccine in China, which mainly covers four subtypes of HPV virus, including 6, 11, 16 and 18, and is suitable for preventive vaccination for women aged 18-45. The vaccine was independently researched and developed by China Academy of Biological Sciences and industrialized and developed by Chengdu Institute of Biological Products, and the two sides jointly conducted clinical research and initiated Phase III clinical trial in May 2018, and obtained a positive recommendation from the interim analysis ...
The progressive neurodegenerative condition affects around 153,000 people in the UK Mission Therapeutics has been awarded $5.2m in funding from Parkinson’s UK’s Virtual Biotech programme and the Michael J. Fox Foundation to advance a potential treatment for early-stage Parkinson’s disease (PD). The funding will help support the company’s ongoing phase 1 programme, which consists of a 28-day dosing of its small drug molecule, MTX325, to assess its safety, tolerability, pharmacokinetic profile and central nervous system penetration in patients living with the neurodegenerative condition. Affecting around 153,000 people in the UK, PD is a progressive neurological condition that damages parts of the brain over time, causing tremors, slow movement and stiff and inflexible muscles. Mission’s MTX325 is a potent, selective, small-molecule brain-penetrant USP30 inhibitor that works to protect dopamine-producing neurons by improving mitochondrial quality and function. Previous research has already shown evidence that a build-up of dysfunctional mitochondria in cells is ...
More than 176,000 people in the UK are living with a stoma, according to NHS data Coloplast has announced the launch of its world-first digital leakage notification system, Heylo, to benefit patients living with a stoma. The new system is now available through the NHS to help alleviate the physical and mental burden of leakage in patients living with a stoma, following an individual consultation and assessment of leakage anxiety. According to NHS data, more than 176,000 people in the UK are living with a stoma, an opening on the abdomen that can be connected to either the digestive or urinary system to remove waste from the body. The most common conditions that can result in stoma surgery include colorectal cancer, bladder cancer, ulcerative colitis, Crohn’s disease and accidental injury. For most patients, leakage of a stoma is currently the biggest challenge, with 92% of people worrying about leakage, impacting ...
Drugdu.com expert’s response: In the medical device industry, there are numerous reports worthy of attention, typically issued by industry research institutions, consulting firms, or relevant government departments. These reports aim to provide comprehensive insights into the current state of the industry, market size, development trends, competitive landscape, and more. Below are some of the most noteworthy medical device industry reports: 1.Global and China Medical Device Market Research Reports Issued by: Reputable global consulting firms such as McKinsey, Boston Consulting Group , Deloitte, among others. Content Overview: These reports comprehensively cover the overall size, growth rates, market segments (including diagnostic equipment, therapeutic devices, consumables, etc.), key market drivers, regional market analyses, competitive landscapes, and future trend forecasts for both the global and Chinese medical device markets. Value: Provide industry players with a holistic view of both global and Chinese markets, facilitating the formulation of internationalization and localization strategies. 2.Medical Device Technology ...
Several types of Cardinal Health syringes are pictured, including a Monoject luer-lock syringe in the center. Cardinal Health recalled certain luer-lock syringes after the FDA said some syringes imported from China are not authorized for sale in the U.S. Retrieved from Cardinal Health on July 02, 2024. The U.S. Food and Drug Administration has cracked down on imports of plastic syringes from China as the agency has raised concerns about quality issues. In November, the FDA said it was evaluating the potential for syringes to suffer problems such as leaks and breakages and advised healthcare providers to “consider using syringes not manufactured in China, if possible.” Since then, the FDA has taken further actions, including issuing import bans to manufacturers Jiangsu Shenli Medical Production, Jiangsu Caina Medical, Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group. The actions came ahead of the Biden administration raising tariffs on medical products imported ...
Whether it’s more sleep or more exercise, simple lifestyle changes may reduce the risk of dementia. Now, a new program from the University of South Australia in collaboration with research partners at Onkaparinga Council and ACH group is helping older Australians make healthier choices to reduce their risk of dementia. Running over 12 weeks, UniSA’s ‘Small Steps’ program will support people aged 65 years and over to make small, incremental changes to their lifestyle choices to improve sleep, reduce sitting time and increase physical activity. UniSA researcher Dr Catherine Yandell says the program hopes to provide participants with genuine insights into their sleep and movement as it relates to dementia risk. “Maintaining an active and healthy lifestyle is essential to reduce the risk of dementia later in life, yet few older adults meet current activity guidelines, and even fewer continue them in the long term,” Dr Yandell says. “Part of ...
By Mike Hollan MTX325 is in Phase I trials and is believed to be able to modify the course of the disease. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK award a multi-million dollar grant to Mission Therapeutics.1 The $5.2 million grant will be used to advance Mission Therapeutics MTX325, a potentially disease modifying treatment for Parkinson’s. In a press release, Mission Therapeutics’ CEO Anker Lundermose said, “This significant grant, from two of the world’s leading Parkinson’s disease organizations, underlines the huge potential of MTX325 as a disease-modifying treatment for this terrible neurodegenerative illness. It also represents a major endorsement of our mitophagy strategy in human diseases including PD.” The company’s chief scientific officer, Dr. Paul Thompson, PhD,, added, “We have already made excellent progress in healthy volunteers with preliminary data from the ongoing clinical trial showing that MTX325 has a good single dose safety profile, ...
European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
“Change begins now,” said the UK’s new prime minister, Sir Keir Starmer, in his 5 July victory speech. Ending the 14-year Conservative party reign, the Labour Party has pledged to bolster the UK pharmaceutical sector through increased investment and regulatory action. Starmer’s government is expected to appoint cabinet members in the coming days while junior ministers will be announced today and early into next week. The new members of parliament (MPs) will soon be sworn in from 9 to 11 July. In his final speech as prime minister, Conservative Party leader Rishi Sunak hailed his party’s work to achieve a decreased inflation rate and implement the Windsor Framework for trade in and out of Northern Ireland. However, in a 5 July speech, Starmer said: “Our work is urgent – and we begin it today.” The Labour Party has already promised extensive change to the UK’s life sciences sector, setting forth ...
Chinese pharmaceutical manufacturer Innovent Biologics has transferred the licence for Fucaso (equecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to its development and commercialisation partner IASO Biotechnology (IASO Bio). Although the companies did not disclose the sale price of the deal, Innovent stated that it would use the proceeds to acquire an 18% stake in IASO Bio. Following the agreement, IASO Bio holds global commercial rights to Fucaso. Fucaso is a B-cell maturation antigen (BCMA) targeting CAR T-cell therapy. It was approved by China’s National Medical Products Administration (NMPA) as a fourth-line therapy to treat relapsed and/or refractory multiple myeloma (r/r MM), last month. The companies have also received an investigational new drug (IND) application for Fucaso as a treatment for r/r MM patients who have undergone up to two lines of prior therapies and are refractory to Revlimid (lenalidomide). Fucaso has also received orphan drug, medicine advanced therapy ...
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