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Global

The latest news from the global pharmaceutical industry

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Eisai and Biogen’s Leqembi launched for AD in China

Eisai and Biogen have announced that Leqembi (lecanemab) has been launched in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia, following its approval in January 2024.

17 July 2024Global
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Eli Lilly and UNICEF extend partnership for risk of non-communicable diseases in young people

Eli Lilly has announced that it will donate $6.5m to the United States Fund for UNICEF in order to expand UNICEF's work to ‘improve the health outcomes of millions of children and youth at risk of noncommunicable diseases (NCDs) living in resource-limited settings in India’, according to the press release.

17 July 2024Global
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FDA grants expanded ODD to immunotherapy created at Roswell Park Comprehensive Cancer Center

The FDA has granted an expanded orphan drug designation (ODD) for brain cancer immunotherapy survaxm, originally created at Roswell Park Comprehensive Cancer Center.

17 July 2024Global
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Merck’s Capvaxive approved by FDA for prevention of pneumococcal disease

Merck has announced that the FDA has approved capvaxive (pneumococcal 21-valent conjugate vaccine).

17 July 2024Global
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FDA approves Eli Lilly’s Kisunla for Alzheimer’s treatment

Eli Lilly has announced that the FDA has approved Kisunla (donanemab-azbt, 350mg/20ml once-monthly injection for iv infusion) for the treatment of adult patients with early symptomatic Alzheimer’s disease (AD).

17 July 2024Global
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AbbVie’s Skyrizi approved by FDA for UC treatment

AbbVie has announced that the FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of adult patients with moderately-to-severely active ulcerative colitis (UC) and moderate to severe crohn’s disease.

17 July 2024Global
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FDA expands approval for Sarepta Therapeutics’ DMD treatment

Sarepta Therapeutics has announced that the FDA has approved an expansion to the labelled indication for Elevidys (delandistrogene moxapar vovec-rokl) to include individuals with DMD with a confirmed mutation in the DMD gene who are at least four years of age.

17 July 2024Global
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FDA approves Pfizer’s Beqvez for treatment of haemophilia B

Pfizer has announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate-to-severe haemophilia B.

4 June 2024Global
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Roche’s HPV self-collection screening option approved by FDA

Roche has announced that the FDA has approved its human papillomavirus (HPV) self-collection solution.

4 June 2024Global
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Amgen’s Imdelltra approved by FDA for extensive-stage small cell lung cancer

Amgen has announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.

4 June 2024Global
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Eko Health’s AI for heart failure detection approved by FDA

Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).

28 April 2024Global
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AstraZeneca & Daiichi Sankyo’s BLA for datopotamab deruxtecan accepted by FDA for breast cancer

AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

28 April 2024Global