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Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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How the patient voice is becoming vital for drug approval

pharmaphorum

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. The earlier HTAs, researchers and pharma companies can start that engagement the better.

Drugs 99
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Can technology help diversify clinical trials?

pharmaphorum

The adoption of digital healthcare tools in clinical research accelerated dramatically during the COVID-19 pandemic and it is expected that such tools will continue to contribute to clinical research in the future. What comes next?

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Where is the drug discovery expertise happening in the UK?

Drug Discovery World

Dr Tralau-Stewart says: “Indeed, many academic institutions have established new ways of supporting the discovery pipeline, providing tech transfer offices to support licensing, and entrepreneurship and start-up support through fundraising, accelerators, and incubators.

Drugs 75
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Why are clinical trials struggling with diversity?

pharmaphorum

Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data. While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go.

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A history of the pharmaceutical industry

pharmaphorum

The Thalidomide scandal of 1961 prompted an increase in the regulation and testing of drugs before licensing, with a new amendment to US Food and Drug Administration (FDA) rules demanding proof of efficacy and accurate disclosure of side-effects for new medications (the Kefauver-Harris Amendment) being implemented in 1962.

Medicine 145
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New horizon for cancer innovation

Drug Discovery World

TH : Increasingly, large pharma companies need scale, agility and access to academic partnerships to succeed. This funding is distributed between funding discovery research at our core institutes, and at universities around the UK, clinical research, cancer grand challenges, and translational research. .

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