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PharmTech Europe

21 July 2015

PHARMTECH.COM

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in this issue

FDA Finalizes Drug Shortage Rule
AMRI Acquires Gadea Pharmaceutical Group
EMA Clarifies HPV Vaccine Safety Profile

Top Stories

Neurological Disorders Drug Development Pipeline has 420 Candidates, Says New Report

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.
/ read more /


FDA Finalizes Drug Shortage Rule

The agency requires early notification of potential drug shortages.
/ read more /

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Bio/Pharma News

Mylan’s Withdrawn Difficult-to-Administer Prefilled Syringe Still on Market, Sparks FDA Concern

Mylan has issued a second notification for the withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.
/ read more /


GSK and Francis Crick Institute Partner on New Scientific Discoveries

This collaboration is said to be the first established between the Crick and a pharmaceutical company.
/ read more /


More Bio/Pharma News

Supplier News

Vetter Introduces New Syringe Closure System for Highly-Sensitive Compounds

Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.
/ read more /


AMRI Acquires Gadea Pharmaceutical Group

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.
/ read more /


More Supplier News

Regulatory News

EMA Clarifies HPV Vaccine Safety Profile

The European Medicines Agency reviews the safety of human papillomavirus vaccines.
/ read more /


ICH Moves Genotoxic Impurities Guideline to Consultation

The International Conference on Harmonization has moved ICH M7(R1) Addendum to Step 3 of the ICH process.
/ read more /


More Regulatory News

Industry News

FDA and EU Regulators Strategize Future Collaboration

EMA, FDA, and the European Commission met to plan collaboration on pharmaceutical drug development and evaluation.
/ read more /


Imperial Innovations Secures GBP50 Million for UK Biotech Sector

The investment will help strengthen biotech spin-offs from the United Kingdom’s leading research-intensive universities.
/ read more /


More Industry News

FEATURED TOPICS

FORMULATION

Solving Poor Solubility to Unlock a Drug’s Potential

Modern methods and modeling offer a better way to understand solubility issues and solve today’s complex formulation challenges.
/ read more /

ANALYTICS

A Risk-Based Approach to Data Integrity

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
/ read more /

DRUG DELIVERY

Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug Delivery

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
/ read more /

INGREDIENTS

Lack of Expertise Hinders Adoption of Continuous API Synthesis

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.
/ read more /


Product/Service Profiles


Catalent

Catalent’s ADVASEPT™ Technology is an advanced aseptic filling solution that reduces and even eliminates the main concerns associated with traditional glass vials, while reducing breakage risks and container weight for transportation and disposal.
/ Read More /


CordenPharma Lipids

CordenPhama experts manufacture Synthetic Lipids as part of their Peptides / Lipids / Carbohydrates Technology Platform – visit CordenPharma at the Controlled Release Society – Booth 903 or see here for more information.
/ Read More /


Shimadzu

The Swiss Knife of analytics
Shimadzu has released its new Nexera UC unified chromatography system. It is the world’s first-ever unified and fully automated instrument combining supercritical fluid extraction (SFE) with supercritical fluid chromatography (SFC).
/ Read More /


VAI

Cleanroom Documentation Systems
Introducing VAI’s Cleanroom Documentation Systems, the Core2Print, Core2Write, and CleanPrint 10 that address the problem of documentation materials that shed fibers or particulates in aseptic GMP operations.
/ Read More /

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Webcasts

Capsule Filling: Manufacturing Efficiency and the Added Value of Technical Service

On Demand

As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.
Sponsored by: Capsugel


Strategies to Accelerate Early Phase Clinical Trials

On Demand

Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by: SGS


more webcasts

on pharmtech tv

PharmTech TV

Biologics Development and Manufacturing Trends Part 1

Biologics Development and Manufacturing Trends Part 2

Cell Therapies

Building Biopharmaceutical Manufacturing Processes

Events

29th Annual Symposium of The Protein Society

22–25 July 2015 | Barcelona, Spain

42nd Annual Meeting & Exposition of the Controlled Release Society

26–29 July 2015| Edinburgh, Scotland


more events

REFERENCE LIBRARY

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 /

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.


more ebooks
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