Search Results for “Clinical Trial” – Page 98 – media

Medicare holds firm on Alzheimer’s drug coverage policy

By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
- Source: drugdu
- 102
- June 3, 2023
UK life sciences sector to receive £650m in government funding

The UK government has announced a £650m funding package to support the continued growth of the life sciences sector. Unveiled by chancellor Jeremy Hunt, the ‘life sci for growth’ package includes £121m to speed up clinical trials and improve access to real-time data, as well as £48m to support scientific innovation in preparing for potential health emergencies. Another £154m has been committed to increase the capacity of the UK Biobank – the biomedical database containing the in-depth genetic information of half a million UK citizens. This funding will go towards a new facility at Manchester Science Park, a new hub to help small to medium sized enterprises (SMEs) collaborate with industry and academia, and better IT to accommodate multi-disciplinary data. A new call for proposals has also been released as part of the initiative that will offer £250m to incentivise pension schemes to invest in the UK’s science and technology ...
- Source: drugdu
- 108
- June 1, 2023
【EXPERT Q&A】How to ace the process of drug registration?

Drugdu.com expert’s response: Drug registration is a complex task that involves multiple steps. To do it well, you need to follow these steps: 1. Understand regulations and guidelines: Firstly, understand the related laws, guidelines, and policies of drug registration to ensure your product complies with the requirements of the country or region where it’s being registered. These laws and guidelines usually cover requirements for drug quality, safety, and efficacy. 2. Prepare registration materials: Prepare relevant registration materials according to the drug registration requirements of the country or region. These materials usually include the chemical, biological, and pharmacological properties of the drug, the drug development process, production technology, quality control, clinical trial data, drug labels, and instructions. Ensure the materials you submit are complete, accurate, and easy to understand. 3. Conduct clinical trials: In some cases, you may need to conduct clinical trials to prove the safety and effectiveness of the ...
- Source: drugdu
- 230
- May 31, 2023
【EXPERT Q&A】What steps does the initiation of a drug development project go through?

Drugdu.com expert’s response: The initiation of a drug development project is a complex process, often involving multiple stages and steps. Here is a general flow for reference: 1.Research background and objectives: Determine the background and objectives of the research, including the type of drug to be developed, therapeutic area, and target patient population, etc. 2.Demand assessment: Assess the market demand, business prospects, and potential risks of developing the drug. 3.Preliminary research: Carry out preliminary research and development work, such as drug molecule design, synthesis, screening, and preliminary in vitro experiments, etc. 4.Development plan: Develop a detailed plan for drug development based on the results of preliminary research, including subsequent experimental design, animal experiments, clinical trials, etc. 5.Project application: Write the project application and submit it to the relevant departments for approval. 6.Project evaluation: Experts and review committees evaluate the project application, including the feasibility and scientific aspects of the development plan. ...
- Source: drugdu
- 245
- May 30, 2023
VarmX raises funds to seek IND approval for VMX-C001

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding. It also enables blood to clot normally in the presence of factor Xa blood clotting inhibitors. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing. The company’s first-in-human study will demonstrate the safety of VMX-C001 and provide clinical proof of concept. Enrolment for this study is completed. Full study results are expected to be announced later this year. Led by Sound Bioventures, the Series B2 financing round has also seen participation from another new investor, the European Innovation Council (EIC) Fund. Existing investors include EQT Life ...
- Source: drugdu
- 109
- May 30, 2023
With Novartis circling, Lilly touts Verzenio’s ability to help cancer patients make memories in TV ad

Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
- Source: drugdu
- 121
- May 27, 2023
Common diabetes drug could be repurposed as a treatment for autoimmune disorders

Swansea University researchers have found that a drug commonly used to treat type 2 diabetes can potentially be used in the treatment of autoimmune disorders. Academics at the University’s Faculty of Medicine, Health and Life Science have found that the drug, canagliflozin (also known as Invokana), could be used to treat autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus as it targets T-cells, which form an essential component of the immune system. Canagliflozin is a drug that controls blood sugar levels in people with type 2 diabetes, however researchers have found an unexpected role for the drug involving the human immune system. Existing research has reported that targeting T-cell metabolism in autoimmunity can lead to therapeutic benefits. T-cells are a type of white blood cell that help the body fight infections and diseases, but in autoimmune diseases they have been observed to attack healthy tissues. The new study, ...
- Source: drugdu
- 130
- May 26, 2023
A larger dose of vitamin D may decrease psychiatric symptoms at school age

It is estimated that every eighth child suffers from a mental health disorder. Several predictors of children’s mental problems have been identified, but much remains uncharted. Previous research suggests that low vitamin D levels in early childhood may be one factor increasing the risk of mental health problems in later life. A recent Finnish study, now published in JAMA Network Open, presents new information on the association between vitamin D intake and mental health. A new study by a team of Finnish researchers has investigated whether a daily vitamin D3 supplement higher than the recommended dose in early childhood reduces the risk of psychiatric symptoms at school age. The study is part of the Vitamin D Intervention in Infants (VIDI) clinical trial, which investigates how early vitamin D3 intervention affects children’s growth and development. In the research, children were randomized as two groups, one receiving the daily standard dose of ...
- Source: drugdu
- 136
- May 25, 2023
Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says

An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
- Source: drugdu
- 146
- May 24, 2023
Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market

Dive Brief: Beta Bionics said it received 510(k) clearance from the Food and Drug Administration for its automated insulin dosing (AID) system, teeing it up to challenge Insulet, Medtronic and Tandem Diabetes Care for the Type 1 diabetes market. The system, iLet Bionic Pancreas, features an insulin pump and dosing software that combine with the Dexcom G6 continuous glucose monitor to automate the calculation and delivery of insulin doses. Beta Bionics, which showed the AID system beat standard of care last year, has differentiated its device through simplification and automation, limiting the information users need to input and preventing them from modifying their insulin doses. Dive Insight: The launch of iLet Bionic Pancreas may serve as a test of whether people with Type 1 diabetes are willing to almost totally cede control of their insulin dosing to an algorithm. Users of existing hybrid closed-loop systems enter information such as basal ...
- Source: drugdu
- 113
- May 24, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.