Search Results for “Clinical Trial” – Page 68 – media

Ascletis Announces Poster Presentation of Phase II Study Final Results of FASN Inhibitor ASC40 for Treatment of Acne at 2024 AAD Annual Meeting

Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States. The summary of the poster is shown as below: Title: First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial Method: This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed. Background: ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de ...
- Source: drugdu
- 118
- March 12, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a once-weekly injection, was not part of this clinical trial. Published clinical trial results for that drug show it led to weight loss of 5.9% measured at 12 weeks. Wegovy, whose main ingredient is the peptide semaglutide, offers one mechanism of action: activating the GLP-1 receptor to ...
- Source: drugdu
- 132
- March 11, 2024
The roadmap for generative AI in the pharma industry

AI remained one of the main talking points at CTS Europe, as the roadmap for generative AI was mapped out. In 2022, the launch of the generative Artificial Intelligence (AI) platform ChatGPT broke the record for the fastest-growing consumer application in history. Following the rapid adoption of AI technologies, the pharma sector is now exploring the capabilities and challenges of generative AI as it remains one of the key trends in the industry. However, despite the recent progress in the use of AI in real-world situations, we are still in the early stages of the AI roadmap, research director at GlobalData Josep Bori, at the recently concluded Clinical Trial Supply (CTS) Europe 2024 meeting. Generative AI is a technology capable of generating text, images or other data using generative models, often in response to prompts. Explaining how generative AI works, Bori said: “AI is trying to optimise the output to ...
- Source: drugdu
- 87
- March 9, 2024
FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
- Source: drugdu
- 123
- March 9, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed. By FRANK VINLUAN An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a ...
- Source: drugdu
- 169
- March 9, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
- 98
- March 8, 2024
FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

Don Tracy, Associate Editor This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing. Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.1 “The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press release. “This is the first US FDA approval of ...
- Source: drugdu
- 120
- March 7, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 131
- March 7, 2024
Longer Treatment Leads to More Liver Benefit

Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022. By FRANK VINLUAN Longer treatment with an Akero Therapeutics drug in development for the liver disease MASH led to better results, including improvement in fibrosis, the liver scarring that is a hallmark of the chronic disorder. Metabolic dysfunction-associated steatohepatitis, or MASH, causes deteriorating liver function that can reach the point of requiring an organ transplant. The fibrosis that develops with MASH is classified in four stages. Stage 4, the most severe, is liver cirrhosis. On Monday, South San Francisco-based Akero reported preliminary results at 96 weeks showing that 75% of patients treated with the highest dose of its drug, efruxifermin, showed improvement of at least one stage of fibrosis without worsening ...
- Source: drugdu
- 111
- March 6, 2024
FDA director signals accelerated approval of gene therapy becoming normal! Multiple gene therapies are expected to be launched this year

“If we don’t move toward accelerated approval, many patients will not be able to receive treatment in a timely manner. For many initial approvals of gene therapies, accelerated approval will become the standard process.” Peter Marks said at a seminar held by the Reagan-Udall Foundation in Washington last week . There are currently more than 10,000 rare diseases, but companies often struggle to bring treatments for these diseases to market due to small patient populations and financial constraints. Accelerated approval is a tool that can advance the development of innovative treatments and ensure that companies do not abandon promising treatments. Peter Marks said: “There are many gene therapies for rare diseases that are almost successful. The key question now is, how do we push them to the finish line smoothly?” For gene therapy for rare diseases, a balance between supervision and science is needed. How to supervise gene therapy more ...
- Source: drugdu
- 124
- March 6, 2024

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