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FDA continues crackdown on plastic syringes made in China

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 ...
- Source: drugdu
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- July 9, 2024
UniSA’s ‘Small Steps’ program promotes healthier lifestyles to reduce dementia risk

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 ...
- Source: drugdu
- 92
- July 9, 2024
Michael J. Fox Foundation and Parkinson’s UK Award $5.2 Million to Mission Therapeutics for Research into Potential Parkinson’s Treatment

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, ...
- Source: drugdu
- 106
- July 9, 2024
Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

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. ...
- Source: drugdu
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- July 9, 2024
New Labour government backs pharma reform in UK

“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 ...
- Source: drugdu
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- July 9, 2024
Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity

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 ...
- Source: drugdu
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- July 9, 2024
Hinova Pharmaceuticals receives FDA Fast Track Designation for HP518 for Treatment of AR+ Triple-Negative Breast Cancer (TNBC)

CHENGDU, China, July 5, 2024 /PRNewswire/ — Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company dedicated to developing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need. About HP518 HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC. In preclinical IND-enabling studies, HP518 has demonstrated promising antitumor activity in AR+ TNBC animal models, showcasing significant tumor reduction and a favorable safety profile. The molecular subforms of TNBC are particularly aggressive forms of breast cancer that lack targeted treatment options, accounting for approximately 15-20% of all breast cancer cases, and are characterized by the absence of estrogen and progesterone receptors ...
- Source: drugdu
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- July 9, 2024
OLYMVAX Trivalent Influenza Virus Cracking Vaccine (MDCK Cells) Clinical Trial Application Accepted

Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX’s application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China. Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses. OLYMVAX’s quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice ...
- Source: drugdu
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- July 9, 2024
NeuroSense Therapeutics shares positive results of lead candidate in ALS

The neurodegenerative disease currently affects more than 200,000 people worldwide NeuroSense Therapeutics has announced positive mid-stage results of its lead drug candidate, PrimeC, in people living with amyotrophic lateral sclerosis (ALS). The phase 2b PARADIGM study has been evaluating PrimeC, a fixed-dose combination of two US Food and Drug Administration (FDA)-approved drugs, Bayer’s ciprofloxacin, a well-known antibiotic, and Pfizer’s Celebrex (celecoxib), a COX inhibitor used to treat inflammation, in 68 people living with the neurodegenerative disease in Canada, Italy and Israel. Affecting more than 200,000 people globally, ALS is a neurological disorder that affects the motor neurons, the nerve cells in the brain and the spinal cord that control voluntary muscle movement and breathing. Previously granted Orphan Drug Designation by the FDA and the European Medicines Agency, PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic ...
- Source: drugdu
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- July 9, 2024
Study reveals mobile phone data can help map the spread of pathogens

Pneumococcus is the leading cause of pneumonia, meningitis and sepsis worldwide A study, published in Nature, has revealed a new way to map the spread and evolution of pathogens, as well as their response to vaccines and antibiotics, using anonymised mobile phone data, to help predict and prevent future outbreaks. The study involved researchers from the Wellcome Sanger Institute, the University of the Witwatersrand, the National Institute for Communicable Disease, South Africa and the University of Cambridge, as well as partners from the Global Pneumococcal Sequencing project. Infectious diseases, including tuberculosis, HIV and COVID-19, have multiple strains or variants that circulate simultaneously. The leading cause of pneumonia, meningitis and sepsis worldwide, the bacterium Streptococcus pneumoniae (pneumococcus) has over 100 types and 900 genetic strains globally. Researchers integrated genomic data from 6,910 pneumococcus samples collected in South Africa between 2000 and 2014 with anonymised human travel patterns collected by Meta2 using ...
- Source: drugdu
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- July 9, 2024

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