Search Results for “EC” – Page 207 – media

Eisai’s Leqembi deemed too costly for NHS

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
- Source: drugdu
- 66
- August 26, 2024
Lexicon to face FDA AdComm for Zynquista approval in diabetes and CKD

It looks like Lexicon Pharmaceuticals’ second bid to get US Food and Drug Administration (FDA) approval for Zynquista (sotagliflozin) will be as arduous as the first go around, as the regulatory agency has convened an advisory committee (AdComm) to evaluate its efficacy. The FDA’s Endocrinologic and Metabolic Drugs AdComm will discuss the benefit/risk profile of Zynquista as an adjunct to insulin therapy for glycaemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The AdComm is set to meet on 31 October 2024. Lexicon added that convening of the AdComm will not affect the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2024 set by the FDA. An AdComm is convened upon request of the FDA to review and evaluate the safety and efficacy data of a therapy. However, the AdComm recommendations are non-binding, with the final decision made by the FDA. The ...
- Source: drugdu
- 74
- August 26, 2024
Leo Pharma’s Timber bet falls flat following Phase III failure

Ayear after hedging its bets on Timber Pharmaceuticals’ dermatology pipeline, Leo Pharma has reported a Phase III failure for the lead asset it acquired at the time. TMB-001, a topical ointment formulation of isotretinoin, came up short in the late-stage trial for patients with moderate to severe congenital ichthyosis. Ichthyosis is an umbrella term for congenital skin conditions that cause dry and scaly skin. In the Phase III ASCEND trial (NCT05295732), Leo stated the therapy did not demonstrate a statistically significant improvement in patients compared to those treated with a vehicle. This meant the primary and key secondary endpoints were not met. The results do not support US regulatory submission, the Danish privately owned company stated in a 21 August press release. There is currently no treatment approved for ichthyosis by the US Food and Drug Administration (FDA). Instead, the condition is managed by hydrating the skin with creams and ...
- Source: drugdu
- 71
- August 26, 2024
CTI announces partnership for oncology drug development

CTI Clinical Trial & Consulting Services (CTI) and Crown Bioscience have announced a strategic partnership aimed at bolstering consulting services for oncology drug development. The collaboration brings together CTI’s clinical and regulatory expertise with Crown Bioscience’s preclinical and translational models, aiming to streamline the transition of oncology compounds from discovery to early-phase global studies. It is set to benefit customers by providing expert guidance that enhances the efficiency of oncology drug development. CTI Global Laboratory Services business development vice-president Ryan Gifford stated: “Crown Bioscience’s leadership in early-phase oncology research and suite of preclinical services complement CTI’s broad spectrum of capabilities. “Together, we can offer enhanced support to our oncology clients and deepen our commitment to advancing cancer research.” The combined expertise is expected to ensure an effective path to clinic, support long-term success in drug development and accelerate the delivery of new oncology treatments to patients. Through the alliance, customers ...
- Source: drugdu
- 65
- August 26, 2024
New Microfluidics Method to Speed Up Blood Analyses

Researchers have developed a new method to accelerate and potentially scale up the process of separating particles in fluids, a technique that could prove useful for analyzing cancer cells from blood. This speedier and more precise method of elasto-inertial microfluidics was developed by a team led by researchers at KTH Royal Institute of Technology (Stockholm, Sweden) and involves controlling the movement of tiny particles in fluids by leveraging both the fluid’s elastic properties and the inertial forces arising from fluid movement. The microfluidic device features specially engineered channels that accommodate larger volumes of fluid rapidly, making it ideal for applications requiring quick, continuous particle separation. These channels efficiently sort and line up particles, essential for distinguishing different particle types. This high precision is achieved through the use of specially formulated fluids with high polymer concentrations, giving the fluid viscoelastic properties similar to egg whites that can both flow and rebound. ...
- Source: drugdu
- 80
- August 23, 2024
Genetic Analysis of Lyme Disease Bacteria to Enable More Accurate Diagnostic Tests

Lyme disease is the most prevalent tick-borne illness in North America and Europe, affecting hundreds of thousands of individuals annually. The disease is caused by bacteria from the Borrelia burgdorferi sensu lato group, which are transmitted to humans through the bites of infected ticks. Symptoms typically include fever, headache, fatigue, and a distinctive skin rash. If not treated promptly, the infection can spread to the joints, heart, and nervous system, leading to more severe complications. Now, researchers have conducted a genetic analysis of the bacteria responsible for Lyme disease, potentially leading to advancements in the diagnosis, treatment, and prevention of this tick-borne illness. A research team led by biologists at CUNY Graduate Center (New York, NY, USA) has mapped the complete genetic sequences of 47 strains of Lyme disease-related bacteria from across the globe, creating a valuable resource for identifying the specific bacterial strains that infect patients. This genetic data ...
- Source: drugdu
- 68
- August 23, 2024
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma

August 21, 2024 By Don Tracy, Associate Editor Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma. Image Credit: Adobe Stock Images/magicmine The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for an immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC). According to BMS, acceptance of the sBLA was based on promising results from the Phase III CheckMate-9DW trial, which demonstrated that the combination significantly improved overall survival (OS) compared to Lenvima (lenvatinib) or Nexavar (sorafenib).1 “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over ...
- Source: drugdu
- 77
- August 23, 2024
CPhI Worldwide Milan -Discover the future of pharma in Europe

Organizer: Informa Markets Date: October 8-10, 2024 Venue: Strada Statale Sempione, 28, 20017 Rho MI Exhibition Hall: Fiera Milano Rho Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Drugs, Other Anti-Infective Agents Excipients and Dosage Forms: Excipients, Glidants, Enteric Materials Natural Extracts: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Ingredients, Functional Food Ingredients, Health Product Ingredients Bioproducts and Reagents: Antibodies, Nucleic Acid/Protein Synthesis, Cell Biology Detection, Animal/Plant Proteins/Antigens/Peptides, Nucleic Acid Analysis, Libraries and Constructions, Biochemistry Technical Services: Project Design/Thesis Outsourcing, Cell Biology, Biochips, Instrument Testing/Maintenance, Molecular Biology, Microbiology Exhibition CPhI Worldwide Mila: CPhI Worldwide is the market leader in the global pharmaceutical ingredients industry. First held in 1990, it has been held annually in major developed cities in Europe. It is a trade exhibition with a large scale, high standard, and well-known reputation in the ...
- Source: drugdu
- 399
- August 23, 2024
Asia Pharma Expo

Organiser：Nexzen Solutions Pvt. Ltd. Time： February 12th – 14th, 2025 address：Plot# 66, Block#C, Umme Kulsum Road, Bashundhara R/A, Dhaka-1229, Dhaka Exhibition hall：International Convention City, Bashundhara Dhaka Product range: Pharmaceutical Processing Machinery (Tablets/Capsules/Liquids/Injections/Ointments/Dry Syrups) Packaging Machinery & Equipment, Packaging Materials, API Consumables, Pharmaceutical Additives, Excipients, Finished Pharmaceutical Products, Formulation Laboratory Reagents Glassware and Equipment Analysis, R&D Equipment, Biotechnology Instruments, Environmental Control Equipment Service Utilities Products, Turnkey Solutions Contractors, Project Consultancy About Asia Pharma Expo : Asia Pharma Expo Dhaka is the largest, most influential, and the only internationally recognized exhibition for pharmaceutical ingredients and equipment in Bangladesh. Endorsed by the Bangladesh Pharmaceutical Industry Association, it serves as a vital platform for pharmaceutical information exchange in Bangladesh and its neighboring regions.
- Source: drugdu
- 206
- August 23, 2024
【EXPERT Q&A】Can veterinary drug API companies succeed in CDMO transformation?

Drugdu.com expert’s response: I agree that the success of a veterinary API (Active Pharmaceutical Ingredient) company’s transition to CDMO (Contract Development and Manufacturing Organization) hinges on both the potential for success and the crucial factors that contribute to it. Here’s a translation of your points into English: I. Potential for Successful Transition Market Demand: With the rapid development of the global pharmaceutical industry, the veterinary drug market has also shown a steady growth trend. The transition of veterinary API companies to CDMO can cater to the outsourcing needs in veterinary drug R&D and production, particularly for those lacking in-house R&D and manufacturing capabilities, making CDMO services all the more crucial. Technical Accumulation: Veterinary API companies have accumulated substantial technical experience and production capabilities through their manufacturing processes, which can be effectively leveraged during the transition to CDMO. By enhancing their R&D capabilities and service standards, these companies can offer higher-quality, ...
- Source: drugdu
- 92
- August 23, 2024

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