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 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 […]

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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. […]

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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 […]

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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 […]

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A Complicated Urinary Tract Infection (cUTI), a severe class of UTI, one of the 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 […]

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Conducting clinical trial feasibility is one of the first and crucial steps involved in any clinical study process. Clinical trial feasibility helps in assessing the potential of investigators, the country’s potential for conducting the trial, and many more aspects involved to execute a clinical trial successfully. Clinical trial feasibility Clinical trial feasibility is an assessment […]

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Approximately one-third of people with Psoriasis report being diagnosed before age 20. The prevalence of the disease in childhood and adolescence ranges between 0.5% and 2%. According to the World Psoriasis Day consortium 125 million people worldwide have Psoriasis. Psoriasis affects about 6.7 million Americans and is estimated to affect 2–4% of the population of […]

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Rosacea is a common chronic inflammatory skin condition that causes redness and visible blood vessels on the face. It may also produce small, red, pus-filled bumps. Rosacea can be mistaken for acne, eczema, or a skin allergy. In the US more than 14 million people are estimated living with Rosacea. What is Rosacea? Rosacea is […]

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