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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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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. AI and future perspectives: a glimpse into tomorrow Figure 2: adapted from Saha, G.

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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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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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Pharmaceutical suspension market to witness accelerated growth

European Pharmaceutical Review

A report by Allied Market Research predicts that the global pharmaceutical suspension market will reach $83.8 The research specified that the parenteral administration sector accounted for more than half of the global pharmaceutical suspension market in 2022. billion by 2032. Having valued $55.5 percent between 2023 and 2032.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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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