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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

BMS and Janssen’s antithrombotic granted FDA fast track designation

The three indications include ischaemic stroke, acute coronary syndrome and atrial fibrillation

- PMLiVE

Janssen signs $245m deal with Cellular Biomedicine for pair of CAR T-cell therapies

The candidates have shown the potential to treat forms of non-Hodgkin’s lymphoma

- PMLiVE

GSK’s RSV vaccine candidate recommended by CHMP for older adults

RSV infections in older adults account for over 270,000 hospitalisations each year in Europe

- PMLiVE

Novartis’ Cosentyx recommended by CHMP for hidradenitis suppurativa

An estimated one in 100 people globally are affected by the inflammatory skin disease

- PMLiVE

Janssen’s Akeega receives EC approval for metastatic prostate cancer

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

- PMLiVE

Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia

Approximately 3,800 people in the UK are diagnosed with chronic lymphocytic leukaemia each year

- PMLiVE

Janssen’s single tablet combination shows promise in phase 3 PAH study

Around 500 to 1,000 cases of pulmonary arterial hypertension are diagnosed each year in the US

- PMLiVE

Janssen reports updated phase 3 results for niraparib combination in prostate cancer

Prostate cancer is the most common cancer affecting men in Europe

- PMLiVE

Bristol Myers Squibb’s plaque psoriasis treatment recommended by CHMP

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

- PMLiVE

Sanofi/Regeneron’s Dupixent recommended by CHMP for atopic dermatitis in children

If approved, the medicine would be the first and only targeted option in the EU for this age group

- PMLiVE

Sandoz’s high concentration Hyrimoz formulation recommended for use in EU

The recommendation includes multiple indications such as rheumatoid arthritis and Crohn’s disease

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