Search Results for “EC” – Page 409 – media

Ipsen/Albireo Look to Add Rare Genetic Disease to Bylvay’s Label

In February 2023, the FDA accepted an sNDA submitted by Albireo, seeking to add the rare genetic disease Alagille syndrome to Bylvay (odevixibat)’s label. The target action date is June 15. Albireo entered into an agreement in January to be acquired by Ipsen Alagille syndrome is a heritable condition characterized by the lack of bile ducts that drain the liver, leading to the accumulation of bile, which ultimately causes organ damage. The disease can also affect the heart, skeleton, eyes, kidneys and central nervous system. Common symptoms include yellow skin or eyes, stunted growth and severe pruritus. Bylvay’s Alagille bid is supported by data from the Phase III ASSERT study, a double-blinded, randomized and placebo-controlled trial that enrolled more than 50 participants across 32 trial sites in North America, the Middle East, Europe and the Asia-Pacific region. In the study’s main analysis, Bylvay significantly reduced pruritus after 6 months of ...
- Source: drugdu
- 109
- June 13, 2023
Ironwood Pushes Gut Drug to Pediatric Setting

By Tristan Manalac On June 14, the FDA is set to release its verdict on Ironwood Pharmaceuticals’ supplemental New Drug Application (sNDA), in which the company proposes to use Linzess (linaclotide) for the treatment of functional constipation in kids and teens aged 6–17 years. Ironwood is developing and commercializing Linzess in collaboration with AbbVie, following a 2015 agreement with Allergan. AbbVie acquired Allergan in 2019. Linzess is a guanylate cyclase-C (GC-C) agonist that works by binding to the GC-C receptor within the intestinal epithelium, which in turn increases fluid secretion, faster transit and lower pain-sensing in the intestine. The drug won the FDA’s approval in August 2012 to treat patients with chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. Linzess’s label bears a boxed warning for risk of serious dehydration when used in children under two years of age. Ironwood supported Linzess’ sNDA with data from a ...
- Source: drugdu
- 217
- June 13, 2023
Medicinal cannabis is a ‘life-changing treatment’ for people with Tourette syndrome

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 ...
- Source: drugdu
- 129
- June 12, 2023
Women feel the pain of losses more than men when faced with risky choices, according to new research

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 ...
- Source: drugdu
- 170
- June 12, 2023
Purolite to build $190M resin plant in Pennsylvania, plans 170 hires

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 ...
- Source: drugdu
- 112
- June 12, 2023
European Commission grants two new marketing authorisations for UCB’s Bimzelx

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 ...
- Source: drugdu
- 108
- June 12, 2023
Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing

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 ...
- Source: drugdu
- 111
- June 12, 2023
Astellas Submits New Drug Application for Zolbetuximab in Japan

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 ...
- Source: drugdu
- 118
- June 12, 2023
China Approves the World’s First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use

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 ...
- Source: drugdu
- 149
- June 12, 2023
In shift away from toxic ethylene oxide, Colorado firm offers ‘green’ chlorine dioxide sterilization

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 ...
- Source: drugdu
- 120
- June 11, 2023

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