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regulatory decisions

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EMA announces launch of two advice pilots to improve clinical trials in Europe

The pilots are part of the Accelerating Clinical Trials in the EU initiative to foster high-quality clinical research

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AstraZeneca’s Tagrisso combination receives CHMP recommendation for advanced lung cancer

More than 450,000 people are diagnosed with lung cancer every year in Europe

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CHMP recommends Valneva’s chikungunya vaccine for use in adults

If approved, Ixchiq will become the first vaccine available in the EU for the mosquito-borne viral disease

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Pfizer’s one-time haemophilia B therapy Durveqtix receives CHMP recommendation

More than 38,000 people worldwide are currently affected by the inherited bleeding disorder

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Takeda’s enzyme replacement therapy recommended by CHMP for rare blood clotting disorder cTTP

If approved, rADAMTS13 will be the first and only enzyme replacement therapy in the EU indicated for cTTP

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BMS announces CHMP recommendation for multiple myeloma therapy Abecma

More than 50,000 cases of the blood cancer are diagnosed in Europe every year

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MHRA launches new International Recognition Procedure to help bring medicines to UK patients

The agency will partner with regulators in several countries including the EU and US

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EC, HMA and EMA publish first version of Union list of critical medicines

The established list aims to prevent potential future shortages of critical medicines in the EU

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Roche’s subcutaneous Tecentriq recommended by CHMP for multiple cancer types

The formulation can cut treatment time by approximately 80% compared to intravenous infusion

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Merck’s Keytruda combination receives CHMP recommendation for biliary tract cancer

Approximately 211,000 people are diagnosed with the disease globally each year

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EMA announces latest action to address critical medicine shortages in EU

The documents will support Member States to collaboratively address shortages

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Takeda announces CHMP recommendation for Adcetris in Hodgkin lymphoma

The ADC has been recommended with doxorubicin, vinblastine and dacarbazine

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