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IBD research smashes recruitment target two years early

by Anna Smith Cambridge University Hospital NHS Foundation Trust has announced that its inflammatory bowel disease (IBD) research has hit its recruitment target of 25,000 …

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FDA Urges Inclusion Of Men In Breast Cancer Clinical Trials

Men with breast cancer have significantly fewer treatment options than women with the disease, partly due to exclusion from many clinical trials. A new document …

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FDA grants Fast Track designation for Farxiga in chronic kidney disease

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the …

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Lilly’s case for Taltz helped by expanded approval

Eli Lilly on Monday won an expanded approval for its psoriasis and arthritis drug Taltz, securing a Food and Drug Administration OK that should help …

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Europe

AstraZeneca’s Breztri scores in COPD trial, amping its case for triple-combo battle against GSK

AstraZeneca and GlaxoSmithKline have long locked horns in their battle for respiratory supremacy with the latter holding the clear advantage in triple-drug inhaler market. Can …

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Spurned by FDA a decade ago, Kyowa Kirin wins nod for Parkinson’s drug

A 10-year wait obviously didn’t discourage Kyowa Kirin from changing the FDA’s mind for its add-on Parkinson’s disease therapy. Tuesday, the FDA finally approved the Japanese pharma’s …

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AstraZeneca’s Farxiga pads its case for new heart-helping approval

AstraZeneca is still stinging after its SGLT2 diabetes drug Farxiga was waved off by the FDA in Type 1 disease. But here’s something that could …

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Europe

Medicines Co. awaits its date with destiny

Investors in The Medicines Company have Sept. 2 circled in red on their calendars. That’s the day the company plans to report the first pivotal …

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Regeneron gets cholesterol drug win where Praluent won’t go

Regeneron Pharmaceuticals said its experimental drug evinacumab significantly lowered “bad” cholesterol levels 49% compared to placebo in a Phase 3 study of patients with homozygous …

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Roche cancer drug the 3rd approved for pan-tumor use

For the third time, the Food and Drug Administration cleared a cancer drug to treat tumors based on a specific genetic signature rather than by …

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