Steve Duffy

Digital Content Editor

Most Recent Articles by Steve Duffy

Novel Inhaled Treatment for Cystic Fibrosis Granted Orphan Drug Designation

Novel Inhaled Treatment for Cystic Fibrosis Granted Orphan Drug Designation

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The FDA has granted Orphan Drug Designation to a novel inhaled treatment that could potentially improve lung function in patients with cystic fibrosis.

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.

Additional Symjepi Dosage Strength Approved for Anaphylaxis Treatment

Additional Symjepi Dosage Strength Approved for Anaphylaxis Treatment

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Both doses will be supplied in single-dose, prefilled syringes for manual injection.

Multivalent Pneumococcal Conjugate Vaccine Gets Breakthrough Tx Designation

Multivalent Pneumococcal Conjugate Vaccine Gets Breakthrough Tx Designation

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The Breakthrough designation follows an FDA examination of results from a Phase 2 randomized, double-blind trial which evaluated the safety and immunogenicity of the treatment in adults aged 60 to 64 years.

Revefenacin Cuts COPD Exacerbation Rates in Phase 3 Studies

Revefenacin Cuts COPD Exacerbation Rates in Phase 3 Studies

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Pooled data from two identical 12-week pivotal Phase 3 trials (N=1229) in patients with moderate to very severe COPD showed that the mean annualized rate of all COPD exacerbations was 0.47, 0.45, and 0.55 for revefenacin 175mcg/day, 88mcg/day, and placebo, respectively.

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