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leukaemia

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Biogen’s Qalsody granted FDA accelerated approval for rare form of ALS

Mutations in the SOD1 gene are responsible for approximately 2% of all cases

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Eli Lilly to sell low blood sugar drug Baqsimi to Amphastar in deal worth over $1bn

The drug is available in 27 markets, with worldwide sales totalling over $139m in 2022

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bluebird bio submits US application for sickle cell gene therapy

The genetic disease affects approximately 100,000 people in the US alone

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Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia

Approximately 3,800 people in the UK are diagnosed with chronic lymphocytic leukaemia each year

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Eli Lilly to invest additional $1.6bn in US manufacturing sites

The company will also be adding another 200 highly skilled jobs at the new facilities

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FDA approves Gamida’s cell therapy for blood cancer patients

Blood cancers represent about 10% of all annual US cancer cases

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Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA

The vaccines are now authorised for all doses in individuals aged six months and older

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Merck KGaA’s MS drug put on partial clinical hold by FDA

Laboratory results suggested there were two cases of drug-induced liver injury during the phase 3 studies

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Eli Lilly increases investment to almost $1bn for new Irish manufacturing facility

The biologics manufacturing site is expected to create more than 300 highly skilled jobs

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FDA proposes improvements for oncology clinical trials supporting accelerated approval

The draft guidance discusses the advantage of randomised clinical trials over single-arm studies

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AbbVie’s Parkinson’s disease therapy application rejected by FDA

The regulator has requested more information on the pump used to administer ABBV-95

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Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test

If approved, the test could streamline the journey to diagnosis for more patients

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