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Gilead’s Biktarvy received EC approval for the treatment of HIV in paediatric populations

After changing to Biktarvy, 98% of patients in two groups were suppressed at week 48

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MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The changes to the terms were also approved by the EC in October

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Regeneron’s Libtayo granted EC approval for recurrent or metastatic cervical cancer

A phase 3 trial demonstrated a 31% reduction in the risk of death compared to chemotherapy

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AbbVie’s Skyrizi receives EC approval for active Crohn’s disease

The approval makes Skyrizi the first specific IL-23 inhibitor as a Crohn's treatment in the EU

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BeiGene’s Brukinsa receives EC approval for chronic lymphocytic leukaemia

The drug showed better results than Imbruvica, a current standard of care treatment

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Sanofi’s Enjaymo receives EC approval for rare autoimmune haemolytic anaemia

Cold agglutinin disease affects around 12,000 people in the US, Europe and Japan

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AstraZeneca/Sanofi’s Beyfortus receives EC approval for prevention of RSV in infants

The decision makes the antibody the first broadly protective option for this age population

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BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

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Johnson & Johnson to acquire Abiomed in deal worth $16.6bn

The agreement will broaden the company’s cardiovascular technologies portfolio

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Kite’s CAR-T therapy Yescarta granted EC approval in second-line lymphoma

The decision is based on results from the phase 2 ZUMA-7 study

Modern Medical Affairs: How to Leverage Tech and Data as an MSL

Dr. Luca Dezzani, VP of US Oncology Medical Affairs at Johnson & Johnson, explores innovation in Medical Affairs, new technologies for data dissemination and medical education, how to engage with...

Impetus Digital

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EC approves Alexion’s Ultomiris as generalised myasthenia gravis treatment

The positive phase 3 trial results assessing the treatment were published in NEJM Evidence

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