Sat.Mar 30, 2024

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J&J's Nipocalimab for FNAIT Gets on Fast Track for Approval

PharmaTech

FDA granted fast track designation to nipocalimab, which J&J is developing for helping alloimmunized pregnant adults treat FNAIT, a rare disease that poses risk to the fetus or newborn.

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New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

PharmaTech

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

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Drug Recall

RX Note

Introduction In general, a drug recall can be seemed as a way to protect the public from a defective or potentially harmful product. It may be conducted on Voluntary recall : A manufacturer/distributor's own initiative or Direct recall : by the Director of Pharmaceutical Services, Ministry of Health Malaysia's request. Classification Drug recalls can be classified to: 3 degrees based on the severity of quality defects and adverse reactions of the products Degree I: Products with major health ris

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Experts Establish First Performance Measures of Lifestyle Medicine Treatments

Pharmacy Times

Investigators identify 32 performance measures in the final set grouped into 10 categories of disease or health condition.

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Line clearance procedure and reconciliation in GMP

GMPSOP

Line clearance procedure and reconciliation in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What is line clearance? Line clearance is a set of activities or checks performed just before an operation can commence. Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch.