When dermatologists spot an unusual mark on a patient’s skin, they face a choice: monitor it for some time or remove it for biopsy. Similarly, when removing breast tumors, surgeons must send excised tissues to pathologists who take several days to determine if any cancerous cells remain, leading to a second surgery for removing additional cells in about 20% of cases. Pathologists process these tissues by slicing them into thin sections and staining them with hematoxylin and eosin (H&E), which enhances the visibility of cellular structures and is crucial for diagnosing cancers and other diseases. However, this method is labor-intensive and irreversible; once a biopsy is sliced in one direction, it cannot be resectioned for alternative views. Now, a “virtual biopsy” could allow dermatologists to forego the scalpel and scan the skin to check for cancerous cells without an incision. Similarly, surgeons might soon be able to determine if they ...
South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, ...
Organiser: JI EXPO Time:9 – 12 Oct 2024 address:Jl. Gatot Subroto, RT.1/RW.3, Gelora, Tanahabang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270,Indonesia Exhibition hall: Balai Sidang Jakarta Convention Center Product range: Apis, intermediates, natural extracts, excipients, formulations, custom manufacturing, biopharmaceuticals, fine chemicals, laboratory equipment, instruments, laboratory appliances, water treatment, environmental and quality control, technical publications, pharmaceutical products, pharmaceuticals, pharmaceutical engineering, materials and packaging, pharmaceutical machinery and equipment About InterPharma: Jakarta Pharmaceutical Exhibition (InterPharma) is the largest and most influential pharmaceutical exhibition in Indonesia. It is one of the important pharmaceutical, pharmaceutical and packaging professional exhibitions in Southeast Asia. It can exhibit the range of apis, intermediates, biopharmaceuticals, medical supplies, material packaging, pharmaceutical machinery and equipment, etc. At the same time, various conferences will be held to discuss the future development trend of the pharmaceutical industry, and the market potential is huge.
Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
Don Tracy, Associate Editor New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube. SK Life Science announced that the FDA has approved two new ingestion methods for Xcorpi (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.1 “The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in ...
Don Tracy, Associate Editor A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia. Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks. EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1 “We are pleased to see a continued and consistent meaningful reduction ...
Shanghai, China & JERSEY CITY, N.J. – April 8, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint ...
Regular aerobic exercise later in life prevents genomic instability characterized by DNA damage and telomere dysfunction, according to a study from the Department of Internal Medicine at the University of Utah. Researchers will present their work this week at the American Physiology Summit, the flagship annual meeting of the American Physiological Society (APS), in Long Beach, California. Jisok Lim, PhD, said, “These new findings will greatly impact our understanding of the mechanisms on how aerobic exercise improves vascular health at the level of genomic stability.” Late-life exercise used to be thought of as ineffective. However, existing studies indicate aerobic exercise later in life lowers the risk of cardiovascular disease-related mortality. Yet, the specific factors contributing to this effect have not been completely understood. Researchers examined whether regular exercise with aging may prevent DNA damage and telomere dysfunction. Telomeres are protective caps at the end of chromosomes. In this study, exercise ...
A project being led by King’s College London (KCL) has received funding from the Department for Science, Innovation and Technology (DSIT) totalling £100,000 to create a platform to boost artificial intelligence (AI)-assisted healthcare for cancer diagnosis. The PharosAI project will develop a platform for AI researchers and companies to access cancer-related datasets to train AI in healthcare settings. One of 12 teams awarded as part of the DSIT’s Research Venture Catalyst Programme, the project will comprise researchers from KCL, Guy’s and St Thomas’s Trust, Bart’s Cancer Institute and Bart’s Health Trust. The platform will help researchers and companies develop, evaluate and deploy NHS-quality AI for cancer diagnosis, offering AI clinical evaluation, deployment, standards validation services and educational programmes. According to the project proposal, researchers aim to develop a data refinery sourced from over 50,000 patient samples from King’s Health Partners Cancer Biobank and the Breast Cancer Now Tissue Bank to ...
myTomorrows has announced a new partnership with a UK-based charity, brainstrust, to support individuals living with brain cancer. The partnership will help equip patients with knowledge of relevant treatment options, participation in clinical trials and access to pre-approved drugs, while supporting clinicians when recruiting patients to relevant clinical trials. Brain tumours affect around 80,000 people in England, with only 12% of patients surviving beyond five years of their diagnosis. As part of the agreement, the charity will provide its patient network with timely, up-to-date and useful information surrounding credible and accessible clinical trials, along with myTomorrow’s expertise and support. In addition, myTomorrow’s trained patient navigators will play a key role as a single point of contact to help guide patients with brain tumours and their loved ones, as well as healthcare professionals, through medical care and help them make the best decisions during their treatment journey. Using a GDPR-compliant ISO ...
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