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MHRA’s AI Airlock to address challenges for regulating AI medical devices

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI). In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023. It highlighted that the regulator is considering the opportunities and risks of AI from three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that produces evidence-based decisions that impact public and patient safety, where evidence is often supplied by third parties. The new sandbox for AI as a ...
- Source: drugdu
- 116
- May 15, 2024
Chiatai Tianqing Enrolls Subjects in a Clinical Study of TQB2223 Injection in Combination with Paanoprilumab for the Treatment of Lymphoma, Lung Cancer and Nasopharyngeal Carcinoma

Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a nationwide Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQB2223 Injection in combination with Paanoprilumab in subjects with advanced malignant tumors. The study has been approved by the State Drug Administration (Notification No. 2023LP00274) and passed the center’s ethics, and is now recruiting nationwide. Trial drug profile TQB2223 injection is a lymphocyte activation gene-3 monoclonal antibody (LAG-3), registered as therapeutic biological product class 1. LAG-3, as an immune checkpoint, is expressed in activated T cells, NK cells, B cells and plasmacytoid dendritic cells, etc., and can negatively regulate T cells, which plays an important role in the maintenance of homeostasis of the body’s immune system and the promotion of tumor immune escape. LAG-3 monoclonal antibody can block the LAG-3 ligand on the cell surface, enhance the secretion of cytokines and exert anti-tumor immunity. Pavelizumab is a PD-1 monoclonal ...
- Source: drugdu
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- May 15, 2024
Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

On May 13, 2024, GlaxoSmithKline (“GSK”) announced that ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration (“SDA”) for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China (“SDA”) for HIV-1 pre-exposure prophylaxis (“PrEP”) in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections (“STIs”) in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release. Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. ...
- Source: drugdu
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- May 15, 2024
CDMEE 2024

Organiser:Sichuan Hospital Association, Sichuan Medical Device Industry Association, Sichuan Rehabilitation Medical Association Time:26- 28 September 2024 address：198 Century City Road, Chengdu City, Sichuan Province Exhibition hall: Chengdu Century City new international Convention and Exhibition Center Product range: Medical equipment exhibition area: imaging equipment, in vitro diagnostic reagents and instruments, disinfection sensor series, medical electronic equipment, medical vehicles, operating rooms and emergency equipment, medical consumables and surgical consumables, medical maintenance accessories and consumables, etc Medical Examination Exhibition area: Medical analysis system, genetic and life science instruments, laboratory case equipment and consumables, pre-examination equipment and consumables, blood collection management system and transfusion supplies, blood and cell analysis system, pre-examination equipment accessories and maintenance consumables, etc Rehabilitation and well-being exhibition area: sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, sensory interactive equipment, assistive devices, etc. Sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, ...
- Source: drugdu
- 141
- May 14, 2024
NHS still faces waiting list challenges

Commenting on the publication today of the NHS monthly performance statistics, Tim Gardner, Assistant Director of Policy at the Health Foundation, said: ‘While the pressure of winter has eased, today’s data shows urgent and emergency care is still feeling the strain. Over 42,000 patients spent more than 12 hours in A&E before being admitted to a bed last month, and 1 in 10 with a serious condition such as a stroke or chest pain waited over an hour for an ambulance. ‘There are some positive signs in areas of cancer care but following several months of progress, the overall waiting list in March 2024 has remained broadly flat. Fewer than expected referrals into specialist care means the recent fall in the waiting list was largely driven by fewer patients joining the list, rather than because substantially more are being treated. The reality is the waiting list is still 7.5 million, ...
- Source: drugdu
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- May 14, 2024
How stricter EtO regs could shape the medtech industry

The Environmental Protection Agency recently implemented new regulations to limit emissions of a common but cancer-causing medical device sterilant, after years of health meetings, lawsuits and debate about how to handle the issue. Medical device companies will need to comply with new requirements governing ethylene oxide (EtO) emissions, and some device sterilizers are searching for suitable alternatives. In April, the EPA published a final rule that sets new limits for medical device sterilizers that use EtO. Now, companies will have three years to comply with the new standards. The agency is also working on a separate set of requirements to reduce EtO exposure for workers in sterilization plants. Long-term exposure to the chemical can increase a person’s lifetime cancer risk. In the meantime, the Food and Drug Administration has been evaluating other ways of sterilizing medical devices and changes companies can make to reduce EtO emissions. It has also launched ...
- Source: drugdu
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- May 14, 2024
Answering the Call

From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients. Yvonne Greenstreet, CEO, Alnylam It’s no surprise that Yvonne Greenstreet is winning awards. On Jan. 9, the Healthcare Businesswomen’s Association (HBA) announced the Alnylam CEO as its 2024 Woman of the Year. In the release, the HBA said that Greenstreet had earned the honor through her “notable and remarkable commitment and valuable contributions to women in the healthcare ecosystem.” It went on to describe Greenstreet as a trailblazer, advocate, and a true leader. Specifically, Greenstreet’s leadership at Alnylam, an RNA interference (RNAi) therapeutics company, was recognized. Since being appointed CEO in October 2021, she has helped steer Alnylam to being named one of Fortune’s Best Workplaces for Women. ...
- Source: drugdu
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- May 14, 2024
Avoiding the Digital Age is Hurting Research Efforts

Mike Hollan Pharmaceutical ExecutivePharmaceutical Executive: May 2024 Mike Hollan, Assistant Managing Editor, Pharmaceutical Executive When it comes to developing new drugs and therapies, there is obviously nothing more important than data. Countless bits of data are collected for each medication before it hits the market, and researchers continue to collect data after that. Even before the modern technology boom, data was a key component of the life sciences industry. In the modern world, data is more valuable than ever. New technologies, such as AI and machine learning algorithms, are capable or collecting, sorting, and analyzing bits of data at a faster rate than ever before. Researchers across almost every industry are seeing the benefits and discovering new ways to innovate based on these discoveries. In the life sciences industry, this data is being used for everything from drug development, market analysis, and even scheduling sales reps calls. It’s undeniable that ...
- Source: drugdu
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- May 14, 2024
RAPT terminates Phase II trials for lead candidate following clinical hold

RAPT Therapeutics has announced plans to terminate two Phase II trials for its lead candidate, zelnecirnon (RPT193), three months after the US Food and Drug Administration (FDA) placed a clinical hold on them. In February, the US regulatory agency placed a clinical hold on the Phase IIa (NCT05935332) and Phase IIb trials (NCT05399368) that evaluated zelnecirnon in atopic dermatitis and moderate to severe asthma, respectively. The hold was placed after a patient in the atopic dermatitis trial suffered liver failure possibly caused by zelnecirnon. Following the trial termination news, RAPT’s stock was down by 41.7% at market close on 9 May, compared to market close on the previous day. Since the clinical hold was announced on 20 February, the company’s stock has dropped by over 82% compared to its peak before the news. RAPT ended Q1 with $141.6m in cash reserves and a net loss of $30.5m. Rapt’s market cap ...
- Source: drugdu
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- May 14, 2024
Hengrui Pharmaceuticals’ HRS5580 for Injection for Prevention of Postoperative Nausea and Vomiting Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which approved the company’s HRS5580 for injection to carry out clinical trials for the prevention of postoperative nausea and vomiting. Postoperative nausea and vomiting (PONV) mainly occurs within 24 hours after surgery, but can also be as long as 3~5 days, is one of the common complications of surgery. The incidence of PONV is estimated to be 20% to 37%, with a probability of up to 80% in high-risk patients. Nausea and vomiting can be a distressing experience for patients when combined with postoperative pain. The effectiveness of the current main clinical agents for the prevention of PONV for the prevention of vomiting after surgery needs to be improved, and the development of new therapeutic agents is urgently needed. HRS5580 for injection is an injectable agent independently ...
- Source: drugdu
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- May 14, 2024

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