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PharmTech Europe

22 December 2015

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Top Stories

Sanofi Discusses Asset Swap with Boehringer Ingelheim

Sanofi enters into exclusive negotiations with Boehringer Ingelheim on a business asset swap.
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Valeant Strikes Novel Drug Distribution Deal with Walgreens

The new arrangement draws from a consignment approach, in which Walgreens will sell—but not directly own—Valeant's products.
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Industry News

EMA Accepts Sandoz's Biosimilar for Etanercept

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.
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Nanotech Drug Delivery Research for Melanoma Treatment

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.
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Bio/Pharma News

Cellectar Biosciences and Pierre Fabre Form Oncology Pact

The aim of the collaboration is to advance the use of Cellectar's phospholipid drug conjugate platform for targeted delivery of a selection of Pierre Fabre's cytotoxics.
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AstraZeneca Partners with WCPR to Research Secretome

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.
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Supplier News

Recipharm Signs Agreement to Manufacture Liproca Depot

Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS' Liproca depot for the treatment of prostate cancer.
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Capsugel to Acquire Xcelience and Powdersize

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.
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FEATURED TOPICS

PEER-REVIEWED

Achieving Balance in Sterile Product Manufacturing

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
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BIOSIMILARS

Determining Biosimilarity

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes for determining biosimilarity.
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FACILITIES

Preventing Room Pressurization Failures

All openings and potential breaches for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
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REGULATIONS

GMP Challenges for Advanced Therapy Medicinal Products

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
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FORMULATION

Optimizing Semisolid Dosage Forms

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.
/ read more /


OUTSOURCING

CMO Investors Have More Money Than Places to Spend It

CMO industry consolidation may be frustrated by a dearth of attractive assets.
/ read more /


Product/Service Profile

Aptar Pharma

APTAR PHARMA PRESENTS A STEP CHANGE IN THE PERFORMANCE OF DF30Plus FOR pMDIs INCORPORATING COC
Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, presents its latest innovation, DF30Plus with COCe.
/ Read more /

Webcasts

Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs

On Demand

Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering.
Sponsored by BASF


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 EMA's Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ


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Events

Access to Safe Medicines Europe 2016

19–20 January 2016 | London, United Kingdom

Pharmaceutical Microbiology

20–21 January 2016 | London, United Kingdom

Pharmapack Europe

10–11 February 2016 | Paris, France


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REFERENCE LIBRARY

Process Analytical Technology Resource Guide Combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOK

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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