Canadian biotech Aspect Biosystems has received a $72.75m government investment to advance its proprietary bioprinting technology. The funding, from the governments of Canada and British Columbia (BC), is set to support a $200m multi-year project to advance Aspect’s clinical biomanufacturing capabilities, full-stack tissue therapeutic platform, and bio-printed tissue therapeutic portfolio. Aspect develops bioprinted tissue therapeutics designed to replace or support specific biological functions. According to the company, these implantable, allogeneic cell-based therapies offer solutions such as retrievable implants, and integrated tissues. Aspect’s tissue therapeutic platform is said to combine the company’s bioprinting technology, therapeutic cells, biomaterials, and computational design. In April 2023, Aspect announced a partnership with Novo Nordisk to produce tissue therapeutics for diabetes. Aspect received $75m from Novo in initial payments, with Novo potentially giving Aspect up to $650m in future payments for each of the four potential products arising from the partnership. The collaboration has so far ...
Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
The glucagon-like peptide 1 (GLP-1) receptor agonists have emerged as blockbuster drugs and have raked in billions in sales. However, the higher demand for these therapies has now led to multiple reports of shortages. In response to these events, the European Medicines Agency (EMA) has put forth recommendations to tackle the shortages of these GLP-1 receptor agonists like Eli Lilly’s Trulicity (dulaglutide), and Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide). Another version of semaglutide, marketed as Wegovy, and Eli Lilly’s Mounjaro (tirzepatide) are approved in the EU for weight management in addition to diet and physical activity. The EMA has recommended that manufacturers and distributors avoid promotional activities for these products until the shortage persists. Cooke noted that EU member states should preserve stock, by controlling/limiting prescriptions. Broich stated that physicians should avoid prescribing GLP-1 receptor agonists for cosmetic use or in obese patients without any co-morbidities or ...
Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. By Frank VinluanDespite some evidence that cannabis reduces intraocular eye pressure from glaucoma, the ophthalmology community hasn’t embraced its use. One reason cited: The short duration of effect means a patient must smoke or ingest a lot of marijuana to maintain its effect throughout the day. Skye Bioscience’s ambitions to bring glaucoma patients these therapeutic benefits in a twice-daily eye drop have missed the mark. The clinical-stage company is now turning its focus to another drug that targets the same receptor in a different way for a different indication — weight loss. In doing so, Skye aims to show it can compete with ...
Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro. By Frank VinluaEli Lilly is boosting its ability to meet growing demand for the metabolic disorder drugs Zepbound and Mounjaro, committing $5.3 billion toward the expansion of a site that will produce the main pharmaceutical ingredient in both medications. Lilly broke ground on the Lebanon, Indiana, site in 2023. The expansion announced Friday brings Lilly’s total investment in the site to $9 billion. The company expects this facility will begin making medicines in late 2026. Mounjaro, approved in 2022 for treating type 2 diabetes, has become a blockbuster seller with 2023 revenue totaling $5.1 billion. Zepbound was approved late last year for chronic weight management. Both medications are incretins, drugs that mimic a gut hormone to ...
On May 16-18, the “23rd China Biologics Conference (CBioPC 2024)” was held in Guangzhou. This is an academic event in the field of biomedicine in China. Zhong Nanshan, recipient of the Order of the Republic and academician of the Chinese Academy of Engineering, Zhang Hui, vice president of the China Academy of Food and Drug Administration, Zhao Bingxiang, general manager of China National Pharmaceutical Group Corporation, and Shao Jingbo, deputy director of Guangzhou Development District Administrative Committee, attended the opening ceremony and delivered speeches. Dr. Wei Zhao, Vice President of Chiatai Tianqing, was invited to attend the conference and introduced the company’s experience in pharmacological development of recombinant coagulation factor drugs. The theme of this conference is biopharmaceutical innovation and public health security, aiming to build biopharmaceutical science and technology capacity with core competitiveness and independent intellectual property rights, vigorously develop new productivity of biopharmaceuticals with Chinese characteristics, and actively ...
Roche is looking to share in the windfall from the sales in obesity therapies as it announces positive results from the Phase Ib trial of its investigational obesity and type 2 diabetes (T2D) therapy. CT-388 is a once-weekly subcutaneous dual glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. It selectively targets two incretin receptors that control food intake, energy absorption and assimilation. The therapy has a similar mechanism of action as Eli Lilly’s Mounjaro (tirzepatide), which generated $1.81bn in sales in Q1 this year, according to Lilly’s financials. Following today’s news, the Swiss company’s share was up by over 3.5% in trading today on the Swiss stock market. Roche’s market cap is SFr190.6bn ($210.8bn). The placebo-controlled Phase Ib trial (NCT04838405) enrolled approximately 96 overweight or obese participants with or without T2D. The participants in the CT-388 group achieved a mean placebo-adjusted weight loss of 18.8% at 24 ...
Don Tracy, Associate Editor In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes. Novo Nordisk announced successful results from the Phase IIIa FRONTIER 2 trial, which evaluated the efficacy and safety of Mim8, a promising new treatment for hemophilia A. According to the company, this trial enrolled 254 participants over the age of 12 years to analyze the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment. The trial met its two primary endpoints, which were to demonstrate significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly administration of Mim8.1 “We are very pleased with the positive results from the FRONTIER 2 clinical trial. These data demonstrate the ability of Mim8 to prevent bleeding episodes effectively and safely in people with ...
Tong Hua Dong Bao Pharmaceutical Co., Ltd (hereinafter referred to as the “Company”) has initiated the Phase I clinical trial in China after receiving the notification of approval for the clinical trial of Degu Insulin Liraglutide Injection from the State Drug Administration and has recently successfully completed the first case of patient dosing. The completion of Phase I clinical trial of Degu Insulin Liraglutide Injection is another significant progress in the development of GLP-1RA compound formulation of insulin analog, which will further enhance the competitiveness of the Company in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has ...
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