Hernias, Diaphragmatic, Congenital

A post hoc analysis found the efficacy of camrelizumab plus rivoceranib was superior to sorafenib regardless of baseline liver function as measured by both albumin-bilirubin grade and Child-Pugh classAnother analysis, of patient-reported outcomes during CARES-310, demonstrated the combination of camrelizumab and rivoceranib was associated with improvement in various quality of life aspects compared to sorafenib in both under-65 and 65-and-over age groupsElevar will also share an Industry Expert Theater presentation at ASCO GI on impact of liver function on survival outcomes in unresectable hepatocellular carcinoma patients during treatment with camrelizumab plus rivoceranib versus sorafenib FORT LEE, N.J., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced it will present two posters and give an Industry Expert Theater presentation at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The posters examine post hoc analyses of clinical data and patient-reported outcomes tied to Elevar’s CARES-310 study (NCT03764293), which assessed the combination of the company’s drug candidates camrelizumab, a PD-1 inhibitor, in combination with rivoceranib, an oral TKI, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC). ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online. Elevar’s poster presentations are: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Date and Time: Jan. 19, 2024, at 12:30 p.m. - 2 p.m. PTAbstract Number: 509Abstract Title: Impact of baseline liver function on survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC) treated with camrelizumab + rivoceranib vs sorafenib: A post hoc analysis of study CARES-310. Date and Time: Jan. 19, 2024, at 12:30 p.m. - 2 p.m. PTAbstract Number: 456Abstract Title: Patient-reported outcomes (PROs) <65 or ≥ 65 years old (yo) from CARES-310 camrelizumab + rivoceranib vs sorafenib as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). Industry Expert Theater presentation details: Date and Time: Jan. 19, 2024; 5:15 p.m. - 6 p.m. PTPresentation Title: Impact of liver function on survival outcomes during treatment with camrelizumab + rivoceranib (cam+rivo) vs sorafenib in uHCC patients: therapeutic implicationsSpeaker: Natalia Raphael, Ph.D., Elevar executive director of medical affairs Session Description: Impact of baseline liver reserve and drug induced hepatotoxicity (DIH) on survival outcomes assessed; time to resolution/discontinuation, impact on QoL of DIH determined. The results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients. “Elevar is pleased that CARES-310 continues to yield results that support the combination of camrelizumab plus rivoceranib as a potentially important therapy for those confronted with hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer. “We look forward to detailing these findings while meeting with our peers at ASCO GI.” One ASCO GI poster is a post hoc analysis of the impact of baseline liver function on survival outcomes in patients with uHCC treated with camrelizumab and rivoceranib in CARES-310. The analysis found the efficacy of camrelizumab plus rivoceranib was superior to sorafenib regardless of baseline liver function as measured by both albumin-bilirubin (ALBI) grade and Child-Pugh (CP) class. Despite a higher rate of grade 3/4 adverse effects, there was no detrimental effect of camrelizumab plus rivoceranib on liver function and overall survival in patients with both mildly and moderately preserved liver function compared to sorafenib. The other poster assessed patient-reported outcomes during CARES-310. Camrelizumab plus rivoceranib demonstrated clinically meaningful benefits in key aspects of the patient experience. Although patients treated with camrelizumab and rivoceranib exhibited higher rate of treatment-related adverse events, the combination did not adversely impact quality of life when compared to sorafenib. Supported by the CARES-310 results, Elevar and Jiangsu Hengrui Pharmaceuticals Co., Ltd. in May 2023 submitted a new drug application (rivoceranib) and biologics license application (camrelizumab) to the U.S. Food and Drug Administration (FDA) for the combination as a first-line treatment option for uHCC. The FDA assigned Prescription Drug User Fee Act (PDUFA) target action dates in May 2024. About Hepatocellular Carcinoma (HCC) HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 6,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021. Elevar has rights to commercialize and develop Hengrui Pharma’s camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea (Oct. 2023). About Elevar Therapeutics Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Rivoceranib, under the name apatinib in China, is commercialized by Hengrui Pharma in China and was approved in China as a single agent for the treatment of gastric cancer (2014), a second-line treatment for advanced HCC (2020), and first-line treatment in combination with camrelizumab for uHCC (2023). It has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 6,000 patients worldwide in numerous cancer indications. Elevar also has rights to commercialize and develop Hengrui Pharma’s camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea (Oct. 2023). Elevar is headquartered in New Jersey, with offices in Ireland and South Korea. Additional information is available at ElevarTherapeutics.com. Media Contact:Rosemary OstmannPhone: 201-615-7751Email: rostmann@rosecomm.com Investor Relations Contact:LifeSci Advisors, LLCAshley R. RobinsonEmail: arr@lifesciadvisors.com

The company that focuses on remedies for gastrointestinal diseases announced on December 7 that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for small molecule Voquenza as a daily treatment for adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024. "Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA's acceptance for filing of our New Drug Application for Voquenza as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, chief operating officer at Phathom. Non-erosive GERD treatment “Non-Erosive GERD represents a substantial segment of the US GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies. “We look forward to working closely with the FDA throughout the review process and if approved, expect to launch Voquenza for this new indication in the third quarter of 2024.” Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. Phathom says there are an estimated 38 million US adults living with Non-Erosive GERD, of these approximately 15 million are diagnosed and treated with a prescription medicine annually. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Episodic heartburn The company says symptoms impact the overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain. Heartburn causes a burning feeling in the chest that is caused by stomach acid traveling up towards the throat – acid reflux. If this becomes regular it can be referred to as GERD. Other symptoms can include a unpleasant sour taste in the mouth, a cough or hiccups that keep returning, a hoarse voice, bad breath or bloating or feeling sick. The symptoms can often worsen when lying down or bending over. Research shows that although lots of people get heartburn from time to time, there are no obvious reasons why although some medicines such as anti-inflammatory painkillers, like ibuprofen, a hiatus hernia (when part of the stomach moves up into the chest, a stomach ulcer or bacterial infection in the stomach can be causes. Phase 3 study Phathom is also finalizing its plans to initiate an additional phase 3 study in 2024 evaluating Voquenza as an investigational as-needed treatment for episodic heartburn relief in adults with non-erosive GERD, a novel dosing treatment regimen for which proton pump inhibitors (PPIs) are not approved in the US. Voquenza (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated for the healing of all grades of erosive esophagitis (erosive GERD) and relief of heartburn associated with Erosive GERD in adults and for the maintenance of healing of all grades of erosive GERD and relief of heartburn associated with Erosive GERD in adults.

VMX 2024 to Feature World-Renowned Veterinary Presenters and the Latest in Disease Management and Diagnostics for Animals of All Kinds ORLANDO, Fla., Dec. 6, 2023 /PRNewswire/ -- Breakthrough drugs that can save the lives of thousands of diabetic cats, new approaches to help veterinarians and pet owners recognize and treat illnesses unique to French bulldogs, and how to better care for bearded dragons, America's most popular pet reptile, are just a sample of the more than 800 continuing education sessions that will be offered at the 41st annual Veterinary Meeting & Expo (VMX). Presented by the North American Veterinary Community (NAVC), VMX is the largest global veterinary conference and sets the direction each year for the $104 billion animal health industry. This forum for the latest advances and innovations in animal health will be held January 13 -17, 2024 in Orlando, Florida. Continue Reading VMX 2024 will look at new medications and how technology is transforming how we diagnose and treat animals. - Dr. Varble Post this Bearded dragons are the most popular reptile pets today "VMX is the world's most comprehensive veterinary conference. As the first veterinary conference of the year, it is where remarkable advances are announced and the newest lifesaving techniques are presented," said Dana Varble, DVM, CAE and NAVC Chief Veterinary Officer. "The global conference attracts the most distinguished veterinary leaders who will share and teach exciting breakthroughs taking place today across the industry. VMX 2024 will look at new medications, many designed specifically for animals, and how technology is transforming how we diagnose and treat animals. It's a very exciting and promising time to be in veterinary medicine." VMX 2024 will be led by world-renowned animal healthcare experts who are available for interviews. Look for more sessions and presenters who will be highlighted this month. See the VMX 2024 Full Program for session dates and times. Audrey Cook, DVM, professor of small animal internal medicine at Texas A&M University, Diplomate of both the American and European Colleges of Veterinary Internal Medicine and a recognized specialist in feline medicine through the American Board of Veterinary Practitioners. Breakthroughs in managing feline diabetes in America's most popular pet. From the veterinarian's perspective, feline diabetes is a very treatable disease – but for the pet owner, it's not so simple. According to Dr. Cook, one in 250 cats is diabetic, and one in 10 cats will be euthanized at the time of diagnosis. Studies suggest that less than two-thirds of cats diagnosed with this condition are still alive after three months. Dr. Cook predicts that thousands of cats will live longer and better lives, thanks to breakthroughs in treatment options for feline diabetes in the form of two newly FDA-approved drugs that replace insulin injections with a simple pill or liquid to manage blood sugar levels. "The mortality rate of feline diabetes is so high not because of the disease but because pet owners do not feel they can provide the care their cats need to live with diabetes," said Cook. "We're massively excited about the huge impact two new game-changing oral treatment options will have on our feline patients. We now have the option to simply give a pill or put some liquid medicine on the cat's food once a day. No more scary needles and regimented schedules. Even more important, with these drugs, there is essentially zero risk of cats experiencing clinical hypoglycemia!" Aida Vientós-Plotts, DVM, PhD, DACVIM (Small Animal Internal Medicine), assistant professor of small animal internal medicine, and the co-founder and co-director of The BREATHE Clinic at the University of Missouri. Frenchies Rule! Now What? – An Internist's Guide to Troubleshooting the Most Popular Breed in the U.S. Dr. Vientós-Plotts will conduct a session about common diseases affecting the most popular dog breed in the United States – French bulldogs, lovingly known as "Frenchies." Particularly, Dr. Vientós-Plotts will be highlighting a group of respiratory and gastrointestinal diseases often considered "normal" in these dogs. She will teach veterinarians what to look for and how to treat French bulldogs and other breeds so they can breathe better, swallow easier and improve their overall health and wellbeing. "Brachycephalic, or flat-nosed breeds like French bulldogs, face many health and respiratory issues due to their signature flat snouts and are susceptible to a variety of conditions, including pneumonia, digestive disorders and hiatal hernias, many of which are intimately interrelated," said Vientós-Plotts. "While behaviors like snoring, spitting up or regurgitating food may be typical in French bulldogs and other brachycephalics, they are not normal and may represent more serious conditions. Learning how to identify and address those conditions as early as possible may result in longer, happier and healthier lives." Stacey Leonatti Wilkinson, DVM, Diplomate ABVP (Reptile & Amphibian), adjunct assistant professor at North Carolina State University College of Veterinary Medicine and owner and head veterinarian at the Avian and Exotic Animal Hospital of Georgia. Myth Busters! Top 5 Common Myths From Bearded Dragon Keepers and How to Address Them. Dr. Leonatti Wilkinson will debunk the most common myths about the most popular reptile pets in the country from what they should eat (no, they should not be eating 50 crickets a day) to how to keep them hydrated and avoid "tail rot." Wilkinson will set the record straight about these popular reptiles and help other professionals relay the best information to the owners of these unique pets. "Bearded dragons are by far the most common reptile pets in captivity. We often see multiple in a day in our practice where we treat only exotic pets. Because of this, the care requirements and veterinary medicine for this species is constantly advancing," said Wilkinson. "When it comes to reptiles, it all depends on husbandry. The animal's health is directly related to proper lighting, temperatures, humidity, caging, diet, supplements, etc. It is not as simple as putting a premade diet in a bowl and taking them outside to use the bathroom. These things are important every day of that reptile's life, and they have to get them started right and be conscientious of everything they are doing for their pet all the time." Set to a veterinary-style World's Fair backdrop, this year's "Show of Shows" theme will offer attendees more than 1,000 hours of continuing education and feature exhibits on the latest in animal healthcare products and diagnostics from more than 600 companies and organizations from around the world in the award-winning VMX Expo Hall. The Expo Hall will also feature headlining entertainment, events and activities, including a carousel, a live miniature horse and carnival games. Credentialed media may attend VMX for free, in-person or virtually. To begin your registration process click here. About the NAVC The North American Veterinary Community (NAVC) is a nonprofit organization dedicated to supporting and advancing veterinary professionals worldwide. The world's leading provider of veterinary continuing education, NAVC delivers essential training, tools and resources for veterinary professionals to stay abreast of advances in animal medicine and provide the best medical care for animals everywhere. Through its commitment to innovation and excellence, the NAVC has developed a diverse portfolio of products and services, including educational events, headlined by VMX, the world's largest, most comprehensive continuing education conference and launchpad for new products and innovations within the veterinary industry; a robust digital platform for virtual learning and engagement; the veterinary industry's largest and award-winning portfolio of trade publications; and an advocacy arm which unites the veterinary community and pet lovers. The NAVC was founded in 1982 and is headquartered in Orlando, Florida. Since 2017, the NAVC has been recognized as one of the Top Workplaces by the Orlando Sentinel. To learn more about the NAVC's products and brands, visit . To see our schedule of upcoming events, visit . SOURCE North American Veterinary Community