Many companies spend a significant amount of cost and manpower on software and data management tools/systems to handle clinical trial activities to build, monitor, and manage clinical trial data. Researchers and CRO utilize many software, web-based applications, and cloud source management tools in various stages of clinical development, and here are some of them Now, […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]
Read More →In recent years, there is a huge leap in the pharma industry towards rare disease research and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies like Novartis, GSK, Roche, and Pfizer are extremely active in […]
Read More →In 2019, the global generic drugs market reached a value of US$ 367 Billion. with a CAGR of 5.7% during the period 2014-2019. The US generic drug market is foreseen to reach US$ 208.6 Billion by 2025, with a projected CAGR of 10.46% during 2020-2025, according to a report by IMARC Group, The global biosimilars […]
Read More →Regulatory agencies in various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work on developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]
Read More →Orphan drug designation for rare disease qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing, so let’s know more about Orphan drug designation Worldwide orphan drug sales are forecast to grow at a CAGR of 12.3% from 2019 to 2024, which is approximately double […]
Read More →Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]
Read More →Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]
Read More →Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment, or last-mile delivery. These challenges are often compounded multi-fold when clinical trials are related to a […]
Read More →Rare disease drug development is gaining interest in the pharma industry. Large pharmaceutical companies have been working for many years. Now, startups, and small and mid-range pharma companies are also gaining traction in rare disease drug development. Developing medicines or drug products for rare diseases is always challenging. This applies to both the scientific and […]
Read More →