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Valneva sells FDA priority review voucher for chikungunya vaccine for $103m

The company received a tropical disease PRV in November following the FDA’s approval of Ixchiq for the prevention of disease caused by chikungunya virus

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FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

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Sanofi/Regeneron’s Dupixent approved by FDA for younger eosinophilic oesophagitis patients

Around 21,000 children aged under 12 years in the US are being treated for the inflammatory disease

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Johnson & Johnson’s bladder cancer drug Balversa granted full FDA approval

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

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Pfizer’s Talzenna recommended by NICE for advanced breast cancer

An estimated 300 patients will be eligible for treatment with the PARP inhibitor

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FDA grants fast track designation to Nurix’s BTK degrader for non-Hodgkin lymphomas

CLL is one of the most common types of leukaemia in adults, with around 18,740 new cases in the US last year

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Takeda’s HyQvia granted FDA approval to treat rare neuromuscular disorder CIDP

Approximately five to seven people per 100,000 in the US are affected by the disorder

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Sanofi/Regeneron’s Dupixent gets US label update for atopic dermatitis

Dupixent’s label now includes data supporting its use in hand and foot atopic dermatitis

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FDA approves Vertex/CRISPR’s Casgevy gene therapy for beta thalassaemia

The companies estimate that approximately 1,000 patients in the US will be eligible for the one-time treatment

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Merck granted FDA approval for Keytruda combination in cervical cancer

The decision marks the third FDA-approved indication for Keytruda in cervical cancer

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Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use

The latest guidance will mean an estimated 5.3 million people will be eligible to access Paxlovid

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Pfizer’s Talzenna combination receives EC approval for metastatic prostate cancer

Approximately 470,000 new cases of prostate cancer were reported in Europe in 2020

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