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PharmTech Europe
25 April 2017

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Top Stories

Fujifilm Increases Production Capacity in the US and UK

The company said it plans to invest $130 million in the United States and the United Kingdom to increase production capacity.
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Modernizing Organic and Elemental Impurities

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
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Sharp Packaging Services Acquires Daiichi Sankyo's Packaging Facility

Sharp acquired the pharmaceutical packaging facility in Bethlehem, PA.
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Industry News

UC Berkeley Appeals CRISPR Decision

UC Berkeley appealed the February 2017 decision that determined Harvard and MIT's Broad Institute and Berkeley's CRISPR-Cas9 technologies were separately patentable.
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Remaining Hyland Baby Teething Tablets Recalled

Standard Homeopathic Company is recalling all lots of Hyland's Baby Teething Tablets and Hyland's Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.
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Regulatory News

FDA Changes Labeling Requirements for Codeine and Tramadol

The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.
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Additional Data Needed for Incyte's Baricitinib

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.
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More Regulatory News

Bio/Pharma News

uniQure Will Not Renew Marketing Authorization of Glybera

The company said it would not renew marketing authorization of Glybera, the first gene-therapy approved in the EU.
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Bristol-Myers Squibb and Nordic Bioscience Collaborate on Fibrosis Biomarker Technology

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).
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More Bio/Pharma News

Supplier News

Cobra Biologics Expands Gene Therapy Manufacturing Operations

Cobra will increase capacity in response to customer demand for DNA and viral vector production.
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Inoviem Scientific Secures Funding to Finance Expansion

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.
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FEATURED TOPICS

EXCIPIENTS

Characterization of Polymeric Excipients

This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP–NF compendia.
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FORMULATION

Wet Granulation Resolves Tablet Reformulation Challenges

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.
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MANUFACTURING

Enabling Fluid Transfer for Cell Therapies: An Industry Challenge

The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
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PEER-REVIEWED RESEARCH

Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough Therapies

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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Product Profiles

Aptar Pharma

eDose Counter for MDIs
Aptar Pharma unveils its eDose Counter for metered dose inhalers (MDIs). Our patented eDose Counter for MDIs is designed to be easy-to-use and reliable, and contributes to patient compliance.
/ Read more/

Capsugel

Vcaps® Enteric Encapsulation Technology
Vcaps® Enteric Capsule is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early-stage development to commercial manufacturing.
/ Read more/

Catalent

Manufacturing and Formulation Solutions for Inhaled Dose Forms
Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.
/ Read more/


UP COMING WEBCASTS

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Implementing Pharmaceutical Elemental Impurity Sample Preparation and Analysis
Live Webcast: Wednesday, May 10 at 11:00am EDT
Register now



Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
Live Webcast: Wednesday, May 24 at 11:00am EDT and Wednesday, May 31 at 11:00am CEST
Register now


ON DEMAND WEBCAST

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Understanding Pharmaceutical Elemental Impurity Regulations and Laboratory Considerations
On Demand
Learn more

Events

Interpack 2017

Dusseldorf, Germany

4–10 May 2017

OSD Continuous Manufacturing in the Current Regulatory Landscape

Floriana, Malta

8–9 May 2017

CPhI North Amercia

Philadelphia, United States

16–18 May 2017


more events

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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