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PharmTech Europe

26 January 2016

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Top Stories

Samsung Bioepis Receives Approval in EU for Enbrel Biosimilar

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.
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Pharmaceutical Companies Sign Declaration to Combat Antimicrobial Resistance

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.
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Industry News

Pharmapack Europe Identifies Key Pharma Trends for 2016

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.
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Hong Kong Drug Manufacturer Receives Warning Letter

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.
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Regulatory News

European Pharmacopoeia Revises Raman Spectroscopy Chapter

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.
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Abbott’s Compounding Pharmacy Recalls Products

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.
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Next Generation HPMC Capsules
Bioequivalence and Functional Performance

On Demand
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules.
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Bio/Pharma News

Stem Cell Treatment Centers Receive FDA Warning for Not Following cGMP Procedures

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.
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US Patent Office Denies Amgen’s Petition to Review Humira Patents

The denial marks a setback for Amgen, whose Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.
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Supplier News

AbbVie Receives Breakthrough Therapy Designation for Venetoclax and Rituximab

FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.
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Aesica Pharmaceuticals Relocates Services to Queenborough

Aesica Pharmaceuticals announced on Jan. 19, 2016 that the company has relocated development and clinical manufacturing services to Queenborough.
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FEATURED TOPICS

VALIDATION

Reducing the Documentation Burden in Process Validation

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.
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PACKAGING FORUM

Parenteral Packaging: 2021

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
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VIEWPOINTS

Global Drug Directions

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.
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EUROPEAN REGULATORY WATCH

A Call for Radical Reformation of the World Health Organization

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
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Product/Service Profile

Aptar Pharma

Aptar Pharma presents DF30Plus with COCe: ultra-clean, robust and versatile at the upcoming Pharmapack Europe conference.
Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, will present its latest innovation, DF30Plus with COCe, at the Pharmapack Europe conference in Paris, to be held on February 10 and 11, 2016.
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Webcasts

Establishing a Risk Management Plan for Compliance and Pharmacovigilance

On Demand

Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency’s Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ


Controlling Contamination in Biopharmaceutical Manufacturing

On Demand
In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services


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on pharmtech tv

PharmTech TV

Tablet Coating

Application of External Lubrication in Tablet Production

FDA Comments on Continuous Manufacturing

Events

Pharmapack Europe

10-11 February, 2016 | Paris, France

BIO Europe Spring 2016

4-6 April, 2016 | Stockholm, Sweden

Global Drug Delivery and Formulation Summit

23-25 May, 2016 | Berlin, Germany


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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.
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More Reference Library

eBOOKS

Drug Development Application Handbook

Pharmaceutical Technology's Drug Development Application Handbook is a compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.

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