Search Results for “Clinical Trial” – Page 83 – media

FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. The study is scheduled to start in the first half of 2024. Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment. Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects ...
- Source: drugdu
- 170
- November 20, 2023
Kite and Arcellx expand strategic collaboration

Gilead company Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas. The parties entered an international strategic deal in December 2022 to jointly develop and market a CART-ddBCMA candidate for relapsed or refractory multiple myeloma. Kite has now exercised its licence option for ACLX-001, an ARC-SparX programme of Arcellx in multiple myeloma. Arcellx is entitled to receive an equity investment of $200m in exchange for 3,242,542 shares of its common stock. The funding will offer 13% ownership of Arcellx to Gilead. Arcellx is also eligible to receive $85m in upfront non-dilutive cash payment, separately from milestone payments in the future. The deal will close by the end of 2023. A BCMA-specific CAR-modified T-cell therapy of Arcellx, CART-ddBCMA is currently in a Phase II clinical trial. Kite executive vice-president Cindy Perettie stated: “We are pleased to see the momentum with the CART-ddBCMA multiple myeloma ...
- Source: drugdu
- 155
- November 20, 2023
IU researchers receive $5 million grant to improve care for adolescents with opioid use disorder

IU School of Medicine researchers are taking steps to improve the accessibility and quality of care for adolescents experiencing opioid use disorder (OUD) and other substance use disorders (SUDs), thanks to a new $5 million grant from the National Institute of Health’s Helping to End Addiction Long-Term (HEAL) Initiative. The grant will fund the new project “Workforce and System Change to Treat Adolescent Opioid Use Disorder within Integrated Pediatric Primary Care” led by faculty from the Department of Psychiatry and Department of Pediatrics. The $5 million will be awarded across 5 years, with formative work happening in the first year before transitioning into a clinical trial phase. “Addressing the growing risk of overdose deaths among adolescents has become a critical concern, and Indiana unfortunately has one of the ten highest rates of adolescent overdose deaths in the United States,” said Zachary Adams, PhD, associate professor of psychiatry at Indiana School ...
- Source: drugdu
- 97
- November 16, 2023
Orphelia pushes boundaries with regulatory barriers for pediatric indications

Orphelia Pharma is taking action to drive regulatory agencies like the European Commission to adapt pharmaceutical legislations that would facilitate the development of rare disease pediatric drugs, like the company’s Kizfizo (Ped-TMZ). Kizfizo, a temozolomide biosimilar, is the first oral liquid suspension of temozolomide designed to act as a monotherapy or as a Kizfizo/DNA topoisomerase inhibitor combination treatment for the treatment of relapsed or refractory (r/r) neuroblastoma. Originally indicated exclusively for the treatment of glioblastoma in adults in the US, temozolomide has been used off label to treat r/r neuroblastoma patients for years. The drug is approved for treating GBM in adults and children in Europe. Use of temozolomide in this manner, especially in children, has its drawbacks because children end up being underdosed, executive chairman Giles Alberici told Pharmaceutical Technology. “You often open the capsules and put that in your water. And this is something that should not be ...
- Source: drugdu
- 90
- November 16, 2023
Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
- 93
- November 16, 2023
Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
- Source: drugdu
- 95
- November 15, 2023
Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease. The decision makes Ixchiq, which is administered as a single intramuscular injection, the world’s first licensed chikungunya vaccine. Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash. “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added: ...
- Source: drugdu
- 94
- November 14, 2023
FDA Approves Takeda’s Treatment for Rare Blood Clotting Disorder

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
- Source: drugdu
- 96
- November 13, 2023
BioNTech acquires right to Biotheus’ bispecific antibody candidate in deal worth over $1bn

BioNTech has entered into an exclusive licensing and collaboration agreement with Biotheus to develop and commercialise its bispecific antibody candidate outside of China, with the deal potentially worth over $1bn. PM8002, which simultaneously targets PD-L1 and VEGF, is currently being evaluated in mid-stage studies in China as both a monotherapy and in combination with chemotherapy in patients with advanced solid tumours. The asset has already demonstrated a positive safety profile and encouraging anti-tumour activity “presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumour microenvironment,” the Chinese biotech said. Under the terms of the agreement, Biotheus will receive an upfront payment of $55m and will be eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1bn, as well as tiered royalties on potential future product sales. The transaction is expected to close in the fourth-quarter of this year subject to customary closing conditions. Xiaolin ...
- Source: drugdu
- 100
- November 10, 2023
FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
- Source: drugdu
- 101
- November 10, 2023

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