In recent years there is a huge leap in the 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, […]

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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 […]

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The US Food and Drug Administration (FDA) in 2019, has approved an increasing number of orphan drugs and biologics, as well as drugs targeted at specific cancers. The Center for Drug Evaluation and Research (CDER) has reported that this value was more than twice compared to the past eight years. Worldwide orphan drug sales are […]

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Financial benefits, faster approvals, and less stringent clinical data requirements are some significant 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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