Approximately 14% of the competition-submitted proposals were selected to receive funding Nine researchers from University College London (UCL) have secured nearly £560m in funding from the European Research Council’s (ERC) Advanced Grants to advance researchers in fields including biochemistry, nanotechnologies and regenerative medicine. Approximately 14% of the competition-submitted proposals were selected for funding, comprising 255 researchers, and could create over 2,000 new jobs. Set up in 2007 by the EU, the ERC has been funding research via the Advanced Grant to universities and research centres across 19 EU member states and associated countries, including the UK, Germany and France. The funding will be used for projects including the study of the roles of priority proteins in cellular quiescence and ageing, the thymus gland’s functions within the immune system and lung cancer. UCL professor Charles Swanton from the UCL Cancer Institute, along with UCL professor Paola Bonfanti and senior group leader ...
Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
Drugdu.com expert’s response: To apply for the certificate of record-filing for online sales of medical devices, the following steps are typically involved: Preparation of Qualifications: Firstly, the medical device online sales enterprise needs to ensure compliance with relevant regulations and requirements, including business licenses, medical device operation permits, etc. Application for Record-filing: Submit the record-filing application to the relevant regulatory authority, which is usually the National Medical Products Administration (NMPA) or local drug regulatory department. The application needs to include basic information about the enterprise, information about the sales platform, types and quantities of medical devices sold, and other relevant information. Record-filing Review: The regulatory authority will review the record-filing application. The review process typically includes assessing whether the sales platform meets requirements and whether the medical devices sold comply with regulatory standards. Issuance of Certificate: If the record-filing application passes the review, the regulatory authority will issue the certificate ...
SHENZHEN, China, April 10, 2024 /PRNewswire/ — Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and safety. As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm’s Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the ...
On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as “sIPV”) received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as “polio”), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech ...
Don Tracy, Associate Editor Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts. Invenra Inc. and Astellas Pharma announced that they have agreed to terms on a collaboration that seeks to utilize Invenra’s B-Body bispecific antibody platform to bolster Astellas’ research and development efforts in bispecific therapeutic research. Per the agreement, Astellas will acquire full access to the B-Body platform, with the opportunity for further license negations upon the completion of this initiative. Both teams stated that they remain dedicated to pushing the boundaries of healthcare through innovative research, with the ultimate goal of providing new, effective treatments to patients worldwide.1 “We are honored to partner with the Astellas team, one of the world’s foremost developers of therapeutics,” said Roland Green, PhD, CEO, Invenra, in a press release. “We are excited by the potential of this partnership to yield profound benefits to ...
Dive Brief Medical Microinstruments (MMI) has received de novo authorization for a robotic system that enables surgeons to reconnect tiny blood vessels, the company said Monday. The Food and Drug Administration authorized the device, called the Symani Surgical System, for soft tissue manipulation to perform microsurgery, a way to restore blood flow and redirect fluid during reconstruction or repair. CEO Mark Toland said the commercial availability of Symani could increase the number of physicians who can perform complicated microsurgical procedures. MMI plans to immediately launch the system in the U.S. Dive Insight Microsurgery and supermicrosurgery, a technique for 0.3mm to 0.8mm vessels, are microscope-assisted operations that enable physicians to take a piece of tissue from one part of the body and use it to reconstruct another area. By reconnecting blood vessels, surgeons can restore form and function to parts of the body damaged by trauma or disease. The potential for ...
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR Researchers from the Universities of Bristol, Bath, King’s College London and the University Medical Center Utrecht have called for a reduction in the use of repeat antibiotic prescriptions in primary care for the same respiratory tract infection (RTI) episode, based on findings from a study. Published in the Journal of Infection, the study found high rates of repeat within-episode prescriptions for RTI in primary care in England, despite evidence of little benefit. Accounting for around 60% of antibiotic prescribing in primary care globally, RTIs are caused by viruses and are one of the key drivers of antimicrobial resistance. The study analysed over 900,000 RTI episodes from clinical records across 530 English general practices. Researchers found that nearly 30% of adults and 10% of children had received a second course of antibiotics within the same ...
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