American Pharmaceutical News In Review

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June 21, 2019

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Integrated Outsourcing from RSMs to APIs

As active pharmaceutical ingredient (API) complexity has increased, so too has the raw material supply chain. Drug manufacturers must ensure that these materials meet strict regulatory guidelines regarding impurity levels, that their quality is well documented to mitigate risk and that they can be traced throughout the supply chain. An integrated supply chain with transparency among sponsors and suppliers ensures that regulatory starting materials (RSMs) are well characterized and free of impurities that can impact the final drug product.

	Industry News

RXQ Compounding Issues Recall of All Sterile Products within Expiry
RXQ is voluntarily recalling all sterile human and animal products within expiry to the user level ... read more »

FDA Approves Victoza for Type 2 Diabetes in Children and Adolescents
Novo Nordisk announced the FDA has approved an expanded indication for Victoza® injection to lower ... read more »

Denovo Biopharma Receives Global Rights to Novel Late-Stage Drug for Alzheimer's Disease
Denovo Biopharma has licensed ORM-12741 from Orion Corporation. read more »

Servier Breaks Ground on Paris-Saclay Research Institute
Servier has laid the foundation stone of its future Research Institute in the Paris-Saclay cluster. read more »

FDA Statement on Effort to Improve Transparency, Predictability for Generic Drug Applicants
The FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines... read more »

Sophiris Bio Receives Positive Feedback from EMA Regarding Prostate Cancer Clinical Trial Design
Sophiris Bio has received formal scientific advice from the EMA regarding a proposed design of a ... read more »

	Featured Articles

Horseshoe Crabs and the Biomedical Industry FAQ Horseshoe crab blood carries factors that react to antigens found on and in gram negative bacteria ... read more »

Polymeric Particles as Cancer Vaccine Vectors Vaccines have been successful at preventing a range of diseases including diphtheria, polio, ... read more »

	Featured Video

Watch Video: Sartorius Stedim Biotech Tour
Sartorius Stedim Biotech Tour read more »

On-Demand Webinar: Beyond Bioprocessing 4.0
In this webinar, you'll learn about market trends, business drivers, and key enablers to drive Bioprocessing 4.0. read more »

	Featured Products

TruCLEAN II Compact Flat Mopping System
read more »

i-Series Integrated HPLC Systems
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	Featured Whitepaper

Influence of Different Lubricants on Tableting Characteristics and Dissolution Behavior
Lubricants are a very important part of the tablet formulation. read more »

Fast Optimization and Simplified Variation of Solvent Composition Using BlendAssist
The Agilent 1260 Infinity II Flexible Pump with BlendAssist enables straightforward variation of modifier/buffer concentration, and eliminates the need for manual mixing of different concentrations. ... read more »

	Events

CPhI Korea
South Korea – 08/21/2019
CPhI Korea provides a dynamic meeting place for a wide range of industry suppliers to engage with purchasers and decision makers from the ... event details »

Eastern Analytical Symposium and Exposition (EAS)
Crowne Plaza Princeton-Conference Center – 11/18/2019
The Eastern Analytical Symposium and Exposition (EAS) is held each year to provide professional scientists and students continuing education in the ... event details »

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