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- PMLiVE

European Medicines Agency

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EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The EU regulator concluded that the benefits of Adakveo did not outweigh its risks

- PMLiVE

Janssen’s Akeega receives EC approval for metastatic prostate cancer

The authorisation marks the first worldwide approval of the niraparib-based combination

- PMLiVE

Incyte’s Opzelura cream receives EC approval for non-segmental vitiligo

The decision makes Opzelura the first approved treatment in the EU to address repigmentation in this patient population

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EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings

The reflection paper offers suggestions on trial design and strategies for minimising bias

- PMLiVE

AbbVie’s Rinvoq approved by EC for Crohn’s disease

The therapy is now the first oral JAK inhibitor authorised to treat this patient population

- PMLiVE

Innovative Trials nominates Eloise Moffett as New VP of Commercial

Eloise Moffett joins Innovative Trials as New Vice President of Commercial to drive business growth globally

Innovative Trials

- PMLiVE

Bristol Myers Squibb’s Sotyktu approved by EC for plaque psoriasis

At least 100 million people worldwide are impacted by some form of psoriasis

- PMLiVE

Sanofi/Regeneron’s Dupixent approved by EC for atopic dermatitis in children

Dupixent is now the first and only targeted medicine in the EU for this patient population

- PMLiVE

MHRA to introduce new UK clinical trials framework

The changes will aim to make it easier to gain approval and to run clinical trials in the UK

- PMLiVE

Kate Shaw comments the appointment of an independent review on clinical trials in the UK.

The news comes after a report by the Association of the British Pharmaceutical Industry (ABPI) highlighted a 44% decline in industry clinical trials in the UK over the last five...

Innovative Trials

Patient Recruitment: Think Global, Act Local

Global clinical trials are a vital component of pharma R&D. Utilizing sites in multiple countries not only provides increased access to eligible and diverse patients - and therefore more robust...

Innovative Trials

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European Commission grants AstraZeneca three new approvals

The indications are for adults with liver and lung cancers, and chronic lymphocytic leukaemia

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