PharmTech Europe, Weekly Alert
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PharmTech Europe
11 July 2017

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Top Stories

FDA Pushes DSCSA Serialization Enforcement Deadline to 2018

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
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Pharmapack Europe Returns to EU in 2018

The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.
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Industry News

Biosimilars Overcome Legal and Analytical Hurdles

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
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GSK and Exscientia to Collaborate on Artificial Intelligence

Partners will use an AI-enabled platform to discover new small molecules across different therapeutic areas.
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More Industry News
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Regulatory News

EU Grants Orphan Drug Designation to ADV7103 for Treatment of Distal Renal Tubulopathy Acidosis

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis.
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FDA to Eliminate Backlog of Orphan Drug Designation Requests

The agency announced a plan to eliminate its existing orphan designation request backlog.
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More Regulatory News

Bio/Pharma News

Pfizer Breaks Ground on New R&D Facility

The company broke ground on a R&D and process development facility in Missouri.
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Heptares and PeptiDream Collaborate on Inflammatory Disease Therapeutics

The collaboration will focus on the discovery, development, and commercialization of novel therapeutics targeting an undisclosed G protein-coupled receptor (GPCR) that plays an important role in inflammatory diseases.
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More Bio/Pharma News

Supplier News

Idifarma Expands Capsule Filling Capabilities

The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain.
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Samsung BioLogics to Manufacture Tildrakizumab

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.
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More Supplier News

FEATURED TOPICS

MANUFACTURING

Optimizing Yields on Modern Tablet Presses

Learn how to prevent common causes of product loss.
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ANALYTICS

Extractables and Leachables Testing for Inhaled Medicines

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.
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FORMULATION

Particle Size Reduction for Investigational New Drugs

Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
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DRUG DEVELOPMENT

Transforming Regulatory Data Management

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
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Product Profiles

Eurofins BioPharma Product Testing

GMP Laboratory Testing Services
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
/ Read more/

Shimadzu

Greater simplicity and reliability in the determination of amino acid sequences
Shimadzu, a worldwide leading manufacturer of analytical instrumentation, provides perfect fit solutions in hardware and software components. For amino acid sequences, the PPSQ 51A / 53 A protein sequencer series and the LabSolutions PPSQ software create user benefits leading to greater simplicity and reliability combined with FDA compliance.
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Events

Excipientfest Asia

Beijing, China

13–14 July 2017

Workshop on Continuous Pharmaceutical Manufacturing: From Powder to the Coated Tablet

Ennigerloh, Germany

19–21 September 2017


more events

Reference Library

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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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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