Don Tracy, Associate Editor Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation. Vasomune Therapeutics announced that the FDA has granted Fast Track designation to AV-001, an investigational drug in development to prevent or treat moderate-to-severe acute respiratory distress syndrome (ARDS) in patients with respiratory infections. According to the company, Phase I data demonstrated the safety and pharmacokinetic profile of AV-001, backing once-daily dosing. Additionally, the treatment showed support for strong Tie2 activation. AV-001 is currently recruiting patients for a Phase IIa trial as an ARDS treatment in pneumonia.1 “Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said Brian Jahns, PharmD, president, chief operating officer, Vasomune Therapeutics, in a press release. “Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical ...
SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
Emcure Pharmaceuticals and its biotech subsidiary, Gennova Biopharmaceuticals have amicably resolved all legal disputes with HDT Bio Corporation. The litigation between them, including before US courts and the arbitral tribunal in London, has been settled and dismissed. Gennova and HDT, who previously collaborated on the successful development of Gennova’s mRNA Covid-19 vaccines, will once again collaborate on the development and commercialisation of mRNA vaccines. The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields. https://www.business-standard.com/companies/news/emcure-gennova-settle-legal-dispute-with-us-based-hdt-bio-sign-agreement-124052300762_1.html
Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
Organiser:Informa Markets Time:10- 12 July 2024 address:60 New Ratchadapisek Road Klongtoey Bangkok 10110 Thailand Exhibition hall:Queen Sirikit National Convention Center Product range: Medical equipment: laboratory equipment and configuration, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc Medical technology: Plastic surgery and rehabilitation technology, medical building facilities and technology, medical information and communication technology, etc Medicine: all kinds of finished drugs, drugs, medical accessories, etc Hospital consumables: disposable medical supplies, medical disinfection supplies, etc Medical items: medical clothing and washing technology, nutrition catering equipment, medical furniture, etc About Asia Health: Bangkok Medical Device Exhibition (Asia Health) is the most authoritative medical device exhibition in Thailand. The radiation market mainly includes India, Malaysia, Indonesia, Vietnam, the Philippines and other Southeast Asian countries. Asia Health is a continuing success for exhibitors and visitors from all over the world.
Mike Hollan The company is collaborating with CPESN USA to bring more services to customers at independent pharmacies across the country. The pharmacy landscape continues to evolve. Express Scripts announced that it is collaborating with CPESN USA in order to provide easier access to a wider range of services at independent pharmacies across the United States.1 The collaboration is the result of guidance that the Independent Pharmacy Advisory Committee provided to Express Scripts. A total of 38 pharmacists from across the United States make up the committee. Express Scripts is the pharmacy benefits service business of Evernorth, which is part of The Cigna Group. Adam Kautzner, Pharm. D., is president of Evernorth Care Management and Express Scripts. In a press release, he said, “Local pharmacies are the doorway to essential health care for many people, and independent pharmacies are critical to closing gaps in care for many communities. This collaboration ...
Biocon announced the signing of an exclusive licensing and supply agreement with Handok, a pharma company in South Korea, for the commercialisation of its vertically integrated, complex drug product, Synthetic Liraglutide. Liraglutide is an injection in a pre-filled pen, used in the treatment of chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. Under the terms of this agreement Biocon will undertake the development, manufacturing and supply of the drug product, and Handok will be responsible for obtaining regulatory approval and commercialisation in the South Korean market. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, said “We are pleased to enter into this strategic partnership with Handok, which will enable patients in South Korea dealing with weight management to gain access to our GLP-1 peptide drug product, Synthetic Liraglutide.” YoungJin Kim, Chairman of Handok, commented, “Liraglutide is an important drug product for treating diabetes ...
Innovent Biologics has unveiled Phase III (DREAMS-2) results for mazdutide, indicating superiority over dulaglutide in glycaemic control for type 2 diabetes (T2D) patients in China. “With its potential to revolutionise T2D treatment, mazdutide’s success could not only reshape the landscape of diabetes therapeutics in China but also underscores the growing demand for innovative solutions amidst the escalating prevalence of T2D in the region,” says GlobalData. Mazdutide is reportedly the only glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist to reach Phase III stage of development (China) for type 2 diabetes (T2D) globally. DREAMS-2 (NCT05606913) Phase III study compared the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with T2D, who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with other oral drugs. The primary endpoint was successfully met, showing the robust glucose-lowering efficacy of mazdutide. The key secondary endpoints showed mazdutide’s superior ...
The total prevalent cases of osteoporosis in the seven major markets (7MM*) are projected to increase from 51.17 million in 2023 to 58.05 million in 2033, with an annual growth rate (AGR) of 1.34 per cent, forecasts GlobalData. GlobalData’s latest report, “Osteoporosis – Epidemiology Analysis and Forecast to 2033,” reveals that in 2033, the US is predicted to have the highest number of total prevalent cases of osteoporosis in the 7MM at 19.91 million, whereas Spain, with nearly 4.24 million cases, will have the lowest number. Osteoporosis is a systemic bone disease characterised by low bone mass, deterioration of bone tissue, and disruption of bone microarchitecture; it can lead to compromised bone strength and an increase in the risk of fractures. It can be further characterised as either primary or secondary. Primary osteoporosis can occur in both sexes at all ages, but often follows menopause in women and occurs later ...
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