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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

- PMLiVE

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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CHMP recommends gene therapy for beta thalassemia and sickle cell disease

If approved, Casgevy will be the only genetic therapy in the EU to treat these conditions

- PMLiVE

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

- PMLiVE

FDA approves two cell-based gene therapies for sickle cell disease

Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older

- PMLiVE

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

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

- PMLiVE

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

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

- PMLiVE

bluebird bio presents positive results for inherited blood disorder gene therapies

The company’s sickle cell disease therapy was accepted for FDA priority review earlier this year

- PMLiVE

bluebird bio to sell FDA priority review voucher for $103m

The company previously sold its second voucher to Bristol Myers Squibb for $95m

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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

- PMLiVE

Takeda announces CHMP recommendation for Adcetris in Hodgkin lymphoma

The ADC has been recommended with doxorubicin, vinblastine and dacarbazine

- PMLiVE

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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