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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Nutraceuticals or Health supplements are gaining importance and becoming a part of the consumer’s daily diet. With the increase in life expectancy and subsequent increase in lifestyle-related diseases, nutraceutical or health supplements have emerged as a necessity for consumers, especially in a developed market and Europe is not an exception to it! Novel food represents […]

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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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Australian regulators do not distinguish between medicines and complementary medicines when it comes to safety, efficacy and quality of the product, including the imported products! Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia. To […]

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Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers and managers are not sure about one aspect or another on how to comprehend, act or change their […]

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Do you know any product segment, where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While, China has been the big production factory for generic drugs and API ingredients for many years, […]

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If you wish to market your nutraceutical products, dietary supplements and herbal products in Australian market, it will be better to realize that the Australian regulatory requirements are quite different from other countries for such products. For example, in the United States of America (USA), such product can reach the pharmacy store, supermarket and retail stores […]

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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 […]

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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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Case record form (CRF) is a wonderful and necessary tool used in clinical trials to collect data from each participating patient. CRF (also, referred as case report form) have historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper have been used, such that one sheet can be added to […]

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