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Reducing real world data lag time for improved patient outcomes

Clarivate

In recent years, there has been an increased focus on real world evidence to advance medical science and improve patient quality of life. Biopharma companies are investing in the use of real world data (RWD) to accelerate innovation. The treatment of patients experiencing acute disease is quite dynamic.

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US FDA accepts Accord BioPharma’s BLA for HLX02 to treat cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. Biosimilars are key to making healthcare more affordable and accessible.

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Embedding the Patient Point of View in Everything You Do

PM360

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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Regulators and HTAs tune in to patient preference data

Clarivate

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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