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Kite cues up first EMA okay for mantle cell lymphoma CAR-T

Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its KTE-X19 therapy for mantle cell lymphoma.

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Novartis’ big bet on inclisiran nears fruition, as CHMP back...

Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma is now a step closer to

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"Tokyo, Japan - May 11, 2012: Pfizer building on May 11, 2012 in Tokyo. Pfizer is one of largest pharmaceutical companies worldwide with tremendous revenue $67.4 bn USD for 2011. It exists since 1849."

Race for COVID-19 vaccine hots up as EMA begins review of Bi...

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZenec

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EMA starts rapid review of Bluebird’s gene therapy for rare ...

Bluebird bio could be just a few months away from approval of its gene therapy for rare disease cerebral adrenoleukodystrophy (CALD) in the EU, after the EMA started an accelerated review.<

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EMA review of AZ’s COVID-19 vaccine imminent; report

The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports

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MHRA publishes guidance on medicine regulation after Brexit

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of th

Kite cues up first EMA okay for mantle cell lymphoma CAR-T

Novartis’ big bet on inclisiran nears fruition, as CHMP back...

Race for COVID-19 vaccine hots up as EMA begins review of Bi...

EMA starts rapid review of Bluebird’s gene therapy for rare ...

EMA review of AZ’s COVID-19 vaccine imminent; report

MHRA publishes guidance on medicine regulation after Brexit

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

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