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FDA issues new draft guidance on decentralised clinical trials

The document includes recommendations on trial design and the use of digital health technologies

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Almirall and Eli Lilly’s lebrikizumab shows continued improvement in atopic dermatitis

The common inflammatory skin disease affects over 4% of adults in the EU

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Pfizer’s next-generation pneumococcal vaccine granted FDA approval

The vaccine can help protect against 20 serotypes of the streptococcus pneumoniae bacteria

Biogen Idec building

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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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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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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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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AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer

An estimated 800 patients will now be eligible for treatment with the drug

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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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