In recent years there is a huge leap of pharma industry towards rare diseases 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 are extremely active in the orphan drugs market. Novartis, GSK, Roche, and […]
Read More →In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]
Read More →Financial benefits, faster approvals and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil and most recently, India. These incentives have been so supportive and convincingly helpful […]
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 relate to a […]
Read More →Rare disease drug development is a rapidly expanding field with growing pressure for getting more orphan drug 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 drugs […]
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 […]
Read More →Over a million people are currently living with TB in Indonesia, making up more than 10% of the world’s TB burden. Of the estimated 32 000 new cases of drug-resistant TB in the country, only about a third of these cases were detected. In a country with a high malaria burden, less than 1% of […]
Read More →Sri Lanka was one of the first countries to embrace the concept of clinical trial registration. The SLCTR was recognized as a Primary Registry of the Registry Network of the WHO‐ICTRP in March 2008, being the fourth Primary Registry to join the Network. Why Sri Lanka? Sri Lanka is an emerging market for clinical trial […]
Read More →New Zealand could be an interesting choice of region for national and international organisations seeking to pursue clinical research and looking for most preferred destination in Asia-Pacific Region. New Zealand, a country named third most beautiful country in the world with stunning and diverse natural beauty, jagged mountains, is full of islands with one of Earth’s most […]
Read More →A Complicated Urinary Tract Infection (cUTI), a severe class of UTI, one of most common infections in the world, is notorious and recognized as a menace globally. cUTI has relapsing and refractory characteristics, and is sometimes life-threatening because of patient predisposing factors as well as the recent worldwide spread of multi-drug resistant bacteria. Pyelonephritis – infections of the kidney, […]
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