Financial benefits, faster approvals, and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for the 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 […]

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Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with a tremendous surge […]

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Rare diseases are rapidly becoming a high priority therapeutic area for our industry. This is needed, especially when fewer than 5% of approx 7,000 rare diseases have drug therapies available, and many of these provide limited benefit. There is also a business case to this, due to a supportive reimbursement environment, particularly in the US. […]

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Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also gaining traction in rare diseases drug development.  Developing medicines or drug products in rare diseases is always challenging for both the scientific and clinical development team […]

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Cost and time for clinical development constitute more than 70% of total development of any drug! Small – mid scale biopharma are known for their innovative approaches, agility and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of the clinical segment. The global CRO market was estimated at $31.6 billion in 2018 and was expected to reach $45.2 billion by 2022, according to a report. What is a CRO? Contract research organizations (CRO) are the companies that provide support to […]

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Hong Kong has a impeccable history of international research with impressive track record of conducting global clinical trials. It has an outstanding healthcare system and indicated as one of the lowest infant mortality rates and the longest life expectancy in the world. Hong Kong is an emerging market for clinical trials. It is the world’s eighth largest […]

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Thailand is the second-largest healthcare market in Southeast Asia after Indonesia making up roughly about 20% of the region’s expenditure. Thailand’s pharmaceutical market is the eighth largest in the Asia Pacific region and considered one of the largest and most developed in ASEAN. Top 5 reasons to choose Thailand as your generic drug market Thailand’s Generic market […]

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Russia has become an increasingly attractive venue for conducting clinical trials for international pharmaceutical companies. Russian clinics and principal investigators have proven to be highly capable of conducting clinical research at a level of quality not less than that of investigators in Western Europe and North America. Why Clinical Trials in Russia? Sponsors are considering […]

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Glomerulonephritis (GN) is a serious kidney disorder that can lead to end-stage renal disease (ESRD), other serious morbidity, or death. Worldwide, IgA Nephropathy (Berger disease) is the most common cause of GN. IgA nephropathy is a autoimmune disease and is one of the most common kidney diseases, other than those caused by diabetes or high blood […]

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