Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain. The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024. With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later ...
The Tyche model could help clinicians and researchers capture crucial information in images Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image. Funded by the National Institute of Health, the Eric and Wendy Schmidt Center and Quanta Computer, the Tyche machine-learning model could help clinicians and researchers capture crucial information. In biomedicine, AI models help clinicians by highlighting pixels that show signs of a certain disease or anomaly. However, these types of models usually only provide one answer. “Having options can help in decision-making” and “so it is important to take this uncertainty into account,” said MIT computer science PhD candidate, Marianne Rakic. Researchers developed Tyche after modifying a straightforward neural network architecture. After feeding the tool a few examples of segmentation tasks, such ...
Breast cancer was responsible for 2.3 million diagnoses and 670,000 deaths globally in 2022 A new report led by the University of Cambridge and supported by the National Institute for Health and Care Research (NIHR) has highlighted inequalities among people living with breast cancer. Published by the Lancet Commission, the report sets out several recommendations to tackle these challenges in breast cancer and builds on previous evidence, new data and patient voices. According to the World Health Organization, breast cancer was responsible for 2.3 million diagnoses and 670,000 global deaths in 2022. Despite recent improvements in breast cancer, including advances in diagnosis and treatment, many people are still disproportionately affected. The commission revealed that progress in research and cancer management has led to a decrease of over 40% in breast cancer mortality, with estimates suggesting that the global breast cancer incidence will increase from 2.3 million new cases in 2020 ...
Organiser: Ministry of Health of Vietnam Time:1 – 3 August 2024 address:Lawrence S. Ting Building 801 Nguyen Van Linh Parkway, Dist. 7 Ho Chi Minh City Vietnam Exhibition hall: Saigon Exhibition & Convention Center Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic equipment and supplies, ophthalmic equipment and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment Analytical instruments: Optical analysis instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analysis instruments, X-ray analysis instruments, gas chromatography, liquid chromatography, thermal analysis instruments, all kinds of portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other general analytical instruments Laboratory equipment: Laboratory instruments and equipment, laboratory automation and accessories, optical instruments and equipment, ...
Mike Hollan The Health Cube will increase remote and virtual care options for populations living in remote areas. AI is helping to expand healthcare solutions to rural areas. While people living in or near highly populated areas tend to have more options when it comes to healthcare, the lack of options in rural areas can be a real issue. For patients living in a state like Alaska, getting access to the proper care can involve traveling long distances, delays in obtaining medication, and sometimes being unable to find the proper specialists. One way that the industry is attempting to solve this issue is by bringing more telehealth and virtual options to these areas. New technologies, such as AI, are making this easier, as the algorithms are better able to match patients with the proper care providers through virtual sessions, while also making it easier to find ways to get the ...
Dive Brief 23andMe CEO Anne Wojcicki plans to take the DNA testing company private, according to a Wednesday filing with the U.S. Securities and Exchange Commission. Wojcicki currently owns more than 20% of the firm’s total outstanding shares, and about 49% of voting rights. She plans to acquire all outstanding shares of the company. The CEO wants to maintain control of 23andMe and would not be willing to support any alternative transaction, according to the filing. Dive Insight 23andMe, which makes consumer genetic tests, has been looking at strategic alternatives as its shares have fallen. The firm went public in 2021 through a merger with a special purpose acquisition company valuing 23andMe at $3.5 billion. Its stock has traded below a dollar this year, down from its IPO price of $10 per share. 23andMe has also expanded into drug research by using its database built up through the DNA testing ...
ENTOD Pharmaceuticals received approval from CDSCO for PresVu, a treatment for presbyopia, by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). PresVu is a eye drop in India designed to alleviate the need for reading glasses among individuals grappling with presbyopia. Presbyopia, characterised by blurred near vision due to the decreased flexibility of the eye’s natural lens, primarily impacts individuals aged 40 and above. PresVu offers swift relief and temporary correction of vision problems associated with presbyopia. PresVu eye drops adjust rapidly to tear pH, ensuring sustained efficacy and safety for long-term use. The company completed development of these eye drops in late 2022 after which it was subjected to clinical testing in India. Reportedly, Phase 3 clinical trials carried out in India and the US have demonstrated PresVu’s efficacy in enhancing close-up vision within minutes of application, with effects lasting up to six hours. ...
Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima. The total addressable market opportunity of Semaglutide in Brazil is approximately $580 million as per the IQVIA MAT Q4 2023. https://www.expresspharma.in/biocon-signs-licensing-and-supply-pact-with-biomm-s-a-for-semaglutide-commercialisation-in-brazil/
Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London. Hodgkinson, who works at at the Lambeth Diabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April. Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added. Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three ...
Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE’s consent to submit a marketing application for this product, which will be submitted in the near future. TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity. The Company announced data from a Phase I ...
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