GSK to Keep Vaccine Prices Low for Gavi Members; PwC Releases FDA-Consumer Report

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Best Testing Practices for Water Activity: A Risk Assessment Tool for Microbial Limits Testing and Stability Testing
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Sponsored by: Decagon Devices

Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
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Sponsored by: Eurofins Lancaster Laboratories

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InformEx 2015
February 03-05, 2015
New Orleans, LA USA
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Pharmapack Europe 2015
February 11-12, 2015
Paris, France

January 29, 2015

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Fill/Finish Capacity Use for Biologics
There are significant differences between small molecules and biologics fill/finish capacity.

Analyzing Protein Aggregation in Biopharmaceuticals
Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

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Developing a Comprehensive Tool Kit for Microbial Identification
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Mitigating Risk for Single-Use Assemblies in Sterile Filling
Risks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks.

GlaxoSmithKline to Keep Vaccine Prices Low for Gavi Members
The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

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Enhancing Quality and Process Efficiency using Continuous Manufacturing Technology for Drug Substance and Drug Product
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PwC Releases Report Highlighting the Need for FDA-Consumer Collaboration
PwC released a report based on surveys completed by consumers and senior industry leaders, which focuses on FDA procedures.

House Cures Proposal Faces Tough Road Ahead
Industry voices concerns over draft legislation that seeks to get much needed treatments to patients.

FDA Releases Photosafety Evaluation Guidance
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

EMA Launches Drug Safety Assessment Platform
The agency creates an electronic central repository to facilitate drug safety assessment reports.

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Pharma Supply Chain Security: Are You in Control?
Live webcast: February 25, 2015 at 11AM ET
In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
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EMA Recommends Suspension of 700 Drugs Tested at GVK Site
GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions.

Ebola Treatments Ramp Up for Clinical Trials
Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

Investment into T-Cell Therapies Continues
Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

FDA Names New Deputy Commissioner for Medical Products and Tobacco
Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

CDC Publishes Information on Reducing Worker Exposure to Hazardous Drugs
A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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Pharmaceutical Technology Solid Dosage Combo
Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development. ... Click here

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