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 →Most of the small and mid-size pharma are stressed out while outsourcing pre-clinical and clinical development to CRO (Contract Research Organization). Selection factors differ while choosing CRO for large and small-medium scale companies. These include factors like budgeting, multiple region selection, and approaches. Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of […]
Read More →Patient recruitment in rare disease clinical trials presents several difficulties. These challenges include limited eligible patients, dispersed geographic distribution, low disease awareness, site and investigator identification difficulties, and ethical considerations. They hinder participant enrollment and cause trial completion delays. Over the past few years, the rate of drug development in rare diseases has been increasing. […]
Read More →The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]
Read More →Rare disease drug development is a rapidly expanding field with growing pressure for getting a more orphan drugs approved to treat rare diseases. There is a vast consensus among patients, health care bodies, governments, etc. to expedite drug development in this field. Some wonderful numbers that attest to growing interest in rare diseases and orphan […]
Read More →Brazil has grown exponentially in clinical research over the last decade. During the past 3 years, clinical trials in Brazil have grown significantly, with the country becoming one of the three most dominant emerging countries, along with India and Russia, which together attract the highest number of Western companies outsourcing clinical trials. Brazil is a […]
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