Steve Duffy

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Most Recent Articles by Steve Duffy

Positive Results for Empagliflozin in Type 1 Diabetes Trials

Positive Results for Empagliflozin in Type 1 Diabetes Trials

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The EASE Phase 3 program included 2 double-blind, placebo-controlled trials investigating the efficacy and safety of empagliflozin as an adjunct to insulin therapy in adults with type 1 diabetes.

FDA Issues Safety Communication Regarding Pen Needle Use

FDA Issues Safety Communication Regarding Pen Needle Use

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Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.

Relacorilant Gets Orphan Drug Designation for Pancreatic Cancer

Relacorilant Gets Orphan Drug Designation for Pancreatic Cancer

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The Company is investigating the treatment as a combination with nab-paclitaxel (Abraxane; Celgene) for pancreatic cancers and other solid tumors.

FDA to Review Eylea for the Treatment of Non-Proliferative Diabetic Retinopathy

FDA to Review Eylea for the Treatment of Non-Proliferative Diabetic Retinopathy

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The sBLA includes results from the Phase 3 PANORAMA trial, which enrolled 402 patients with NPDR.

Akcea and Ionis Receive Complete Response Letter for WAYLIVRA from FDA

Akcea and Ionis Receive Complete Response Letter for WAYLIVRA from FDA

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"We are extremely disappointed with the FDA's decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS," said Akcea CEO, Paula Soteropoulos.

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