Pharmascience, Inc.

WEDNESDAY, March 5, 2025 -- Gastrointestinal complications from alcohol are increasing among adolescents and young adults, according to a research letter published online Feb. 27 in JAMA Network Open . Oril Chapman, M.D., from Queen’s University in Ontario, Canada, and colleagues described the epidemiology of incident emergency department or inpatient encounters for end-organ complications from alcohol among 11,508 adolescents and young adults (aged 13 to 39 years) from 2003 to 2021. The researchers found that most identified cases were male (64 percent). Complications involving the pancreas were more frequent than liver-related complications (29 versus 19 percent), including acute pancreatitis (92 percent). The incidence of pancreatitis increased by 7 percent per year in men and 12 percent per year in women, while liver-related complications increased by 6 percent per year in men and 9 percent per year in women. "These findings underscore the importance of gastroenterologists in caring for individuals with harmful alcohol use and support the integration of addiction medicine into gastroenterology training along with consideration for multidisciplinary gastroenterology-addiction medicine clinics," the authors write. "Future research to understand these observations and evaluations in other age groups is urgently needed." One author disclosed financial ties to Olympus, Pendopharm, Vantage Endoscopy, and Pentax. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Hypoparathyroidism is a rare endocrine disease characterised by insufficient levels of the parathyroid hormone. Credit: Jo Panuwat D/Shutterstock. Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH (palopegteriparatide) to treat hypoparathyroidism in adults. Hypoparathyroidism is a rare endocrine disease characterised by insufficient levels of the parathyroid hormone, affecting multiple organs. A prodrug of parathyroid hormone (PTH[1-34]), YORVIPATH is administered once a day. It aims to provide a continuous exposure to released PTH over a dosing period of 24 hours. Upon the launch of YORVIPATH, Ascendis intends to introduce a comprehensive suite of patient services through its US Ascendis Signature Access Program. These services assist patients in navigating their treatment journey and offer financial assistance to those eligible. See Also: Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world The latest approval for YORVIPATH was based on a thorough review of the clinical package for TransCon PTH (palopegteriparatide), submitted with the new drug application. The package included findings from the global Phase II PaTH Forward and Phase III PaTHway trials. Ascendis is currently finalising the manufacturing of the commercial product for the US market. The initial supply will become available in the first quarter of 2025. The company also plans to request FDA approval to commercialise the existing manufactured product. If approved, this could allow for an earlier introduction in the US market by the fourth quarter of 2024. Ascendis Pharma president and CEO Jan Mikkelsen said: “FDA approval of our second TransCon product, YORVIPATH, reflects our values and dedication to following the science to help patients, as well as our unwavering commitment these past years to addressing the significant unmet medical needs of the hypoparathyroidism community in the US. “We are deeply grateful to patients, clinicians and advocates for their many contributions to this important milestone.” In July 2024, the company entered an exclusive distribution agreement with Pendopharm to offer the hypoparathyroidism treatment TransCon PTH in the Canadian market.

Chronic hypoparathyroidism is a rare endocrine disorder characterised by low or inadequate levels of PTH. Credit: Pixel-Shot / Shutterstock. Pharmascience unit Pendopharm has entered an exclusive distribution agreement with Ascendis Pharma to bring the hypoparathyroidism treatment TransCon PTH (palopegteriparatide) to the Canadian market. Pendopharm will be responsible for securing regulatory approval and overseeing the commercialisation of the product in the country. Neither companies has disclosed the financial terms of the deal. Ascendis Pharma executive vice-president and chief commercial officer Camilla Harder Hartvig stated: “We are delighted to partner with Pendopharm to bring TransCon PTH to Canada, contributing to our shared goal of making a meaningful difference in the lives of patients living with chronic hypoparathyroidism.” A parathyroid hormone (PTH) replacement therapy, TransCon PTH is aimed at treating chronic hypoparathyroidism, a rare endocrine disorder characterised by low or inadequate levels of PTH. See Also: HF-158K1 by HighField Biopharmaceuticals for Bladder Cancer: Likelihood of Approval Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity The therapy has already secured approval in the European Union, the European Economic Area and Great Britain under the brand name YORVIPATH, specifically for adult patients. TransCon PTH is undergoing development for the same indication in the US, Japan and other international markets. Pendopharm vice-president and GM Jad Isber stated: “This partnership represents Pendopharm’s commitment to bringing innovative medicines that address unmet medical needs to Canadian patients. “We look forward to working with Canadian endocrinologists to make TransCon PTH available to all patients who may benefit from it.” In May 2024, Pendopharm announced the renewal of a distribution agreement with Anika Therapeutics for Cingal, Monovisc and Orthovisc up to 2030.