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Mundipharma

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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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Gilead’s Veklury recommended by CHMP for COVID-19 in patients with hepatic impairment

If approved, Veklury would become the first COVID-19 antiviral authorised for use across all stages of liver disease

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Almirall receives CHMP recommendation for lebrikizumab in atopic dermatitis

The drug has been recommended as a treatment option for adult and adolescent patients

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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP

Doses will be ready to ship immediately upon authorisation by the European Commission

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EMA endorses digital measure as primary endpoint in Duchenne muscular dystrophy trials

The decision qualifies SV95C as an alternative to the widely used six-minute walking test

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

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