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ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

Fierce Pharma

ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy. Positive FDA advisory committee votes aren’t always a blueprint for approval. Positive FDA advisory committee votes aren’t always a blueprint for approval.

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Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

Fierce Pharma

Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg When it comes to heart failure medication, a labeling mix-up can have dire consequences. mg dose, and vice versa.

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Jazz Pharmaceuticals: 20 years of patient impact

Fierce Pharma

In this interview, Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, discusses Jazz’s 20-year legacy and what it means to create an organization that is both patient-focused and a great place | Jazz Pharmaceuticals’ Chairman and CEO discusses the company’s longstanding history of bringing new medicines to patients with limited or no options.

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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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AI-supported spectroscopy delivers superior pharmaceutical packaging QC

European Pharmaceutical Review

A paper published in the IEEE Sensors Journal has demonstrated 100 percent inline pharmaceutical packaging content verification by combining standard diffuse reflectance MOEMS-EC-QCL spectroscopy with artificial intelligence (AI). Current quality control challenges in pharmaceutical packaging Flores et al. Flores et al.

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Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

The post Achieving pharmaceutical drug traceability compliance appeared first on European Pharmaceutical Review.

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Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34