Australian researchers have published the first robust clinical study proving that medicinal cannabis effectively treats the debilitating effects of Tourette syndrome. The findings—which show a statistically and clinically significant reduction in motor and vocal tics in just six weeks—are published in the journal NEJM Evidence. The clinical trial was led by neuropsychiatrist Dr. Philip Mosley, a Research Fellow at the Wesley Research Institute and QIMR Berghofer Medical Research Institute. The University of Sydney’s Lambert Initiative for Cannabinoid Therapeutics, with Wesley Research Institute, assisted with study design and execution, and analyzed blood levels of cannabinoids among participants. The analysis found a significant association between levels of cannabis in the bloodstream and the response to active treatment. THC (tetrahydrocannabinol) is the active hallucinogenic compound in cannabis that produces a “high” effect, while CBD (cannabidiol) is a non-psychoactive compound. Both are used medicinally in Australia. Study co-author Professor Iain McGregor, the Academic Director ...
Women are less willing to take risks than men because they are more sensitive to the pain of any losses they might incur than any gains they might make, new research from the University of Bath School of Management shows. Published in the British Psychological Society’s British Journal of Psychology, the study—”Gender differences in optimism, loss aversion and attitudes toward risk”—also finds that men are ‘significantly’ more optimistic than women, making them more willing to take risks. Researcher Dr. Chris Dawson, associate professor in business economics at the University of Bath School of Management, said the findings were significant and could help explain sex-specific outcomes in different employment sectors, and in financial markets. “It is widely acknowledged that men, across many domains, take more risks than women. These differences in how the sexes view risk can have significant effects,” Dr. Dawson says. “For instance, differences between the sexes in risk ...
Purolite, a subsidiary of Ecolab that produces purification resins for drug manufacturing, earmarked at least $190 million to build a production plant that will employ 170 workers.The facility, which will produce a variety of products for the healthcare and drug manufacturing industries, will be located in Landenberg, Pennsylvania, according to a June 6 press release from Gov. Josh Shapiro’s office. Resins are used to purify process streams during drug manufacturing and are considered critical to final product quality although they are not part of the finished product. The facility is expected to be completed by the first half of 2025. It will represent the first site in Purolite’s U.S. biologics division. “Purolite’s new facility will help bring security of supply to our global pharmaceutical and biotech customers, enabling lifesaving drugs to reach patients fast,” Hayley Crowe, Purolite’s senior vice president and general manager, said in the release. Purolite received a ...
Global CDMO giant Catalent, which has been struggling through difficult financial times, added more biologic processes to its OneBio platform, which features capabilities for antibody and recombinant proteins, cell and gene therapies, and messenger RNA.The rollout of the added services is part of the company’s participation at the BIO International Convention taking place in Boston this week, Catalent said in a June 5 press release. The additions come in the wake of the CDMO delaying the release of its earnings report multiple times after admitting in April that it was struggling with “productivity issues” and high costs at three major production sites—including two of its largest. The locations at issue include Catalent’s gene therapy manufacturing site in Harmans, Maryland, as well as its drug product and drug substance plants in Bloomington, Indiana, and Brussels, Belgium. Catalent’s problems may have caused life sciences conglomerate Danaher to shelve plans in April to ...
The European Commission (EC) has granted UCB’s Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The marketing authorisations, which follow a pair of recommendations from the European Medicines Agency’s human medicines committee earlier this year, make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications. The authorisation for PsA – a type of arthritis that affects some patients with psoriasis – specifically applies to those with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs. The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations. “The approval of [Bimzelx] in PsA provides rheumatologists and dermatologists ...
Samsung Biologics has announced a strategic collaboration with Pfizer for the long-term commercial manufacturing of the latter’s multi-product biosimilars portfolio. Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more capacity for manufacturing for the biosimilars portfolio. The portfolio will cover inflammation, oncology and immunology. Samsung will use its new facility, Plant 4, for the products manufacturing. Samsung Biologics president and CEO John Rim said: “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with ...
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
CHENGDU, China, June 8, 2023 /PRNewswire/ — On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China. This is the first COVID-19 vaccine in the world approved for EUA against XBB descendent lineages of SARS-CoV-2. It demonstrates that China is leading the world in the development of COVID-19 vaccines. WestVac Biopharma and its subsidiary company WestVac Biopharma (Guangzhou) leveraged the rapid response of the insect cell expression platform on constructing the vector for Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell), which is of high purity and high quality for human use. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD and HR proteins of the COVID-19 subvariants XBB.1.5 and BA.5 and self-assembled into stable trimeric protein particles with ...
Dive Brief Boulder Sterilization is introducing contract chlorine dioxide sterilization services this summer to provide medical device manufacturers with an alternative to ethylene oxide (EtO). The rollout of the service will make Boulder Sterilization, a division of Boulder iQ, part of a small group of companies to offer medtech sterilization using the gas and, it claims, the only provider to offer both EtO and chlorine dioxide services. Boulder Sterilization’s addition of chlorine dioxide capabilities comes as the industry races to find alternatives to EtO ahead of restrictions on the use of the carcinogenic gas. Dive Insight Interest in using chlorine dioxide to sterilize medical devices dates back decades. A patent filed in 1982 described the use of chlorine dioxide to “sterilize surfaces, especially the gas impermeable surfaces of implements commonly employed in the medical sciences.” Yet, while some sterilization companies such as ClorDiSys Solutions have deployed the approach, EtO has ...
Researchers from The University of Texas at El Paso’s School of Pharmacy will explore the viability of a new treatment for vascular dementia, thanks to a $2.2 million grant from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS). The grant builds on work that’s previously been done by the team and their collaborators. Vascular dementia -; the second most common type of dementia worldwide -; is caused by reduced or blocked blood flow in the brain. Similar to Alzheimer’s disease, vascular dementia causes memory loss and cognitive problems such as confusion, slowed thinking, and difficulty with problem solving and speaking. Mohammad Iqbal Bhuiyan, Ph.D., assistant professor in the UTEP School of Pharmacy, is the project’s principal investigator. His NINDS-funded research will focus on better understanding the biological triggers behind vascular dementia and investigating a new candidate drug, known as “ZT-1a,” to counteract the condition. ...
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