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PharmTech Europe

15 September 2015

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Cipla Acquires InvaGen and Exelan
EMA Sets Up Workshop on Orphan Drugs
Certifying Excipient cGMPs

Top Stories

Vernalis Launches Extended-Release Cough Relief Syrup

Tuzistra XR for cough relief is said to be the only twice-daily, extended-release codeine-based cough and cold syrup available in the US.
/ read more /


Cipla Acquires US Companies InvaGen and Exelan

Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.
/ read more /


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Bio/Pharma News

Sandoz Officially Launches Zarxio

After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio was officially launched commercially on 3 September 2015.
/ read more /


Boehringer Ingelheim Licenses Expression Technology Platform

The platform, developed by Vectron Biosolutions, will be used for BI’s in-house pipeline and for its outsourcing clients.
/ read more /


More Bio/Pharma News

Supplier News

SGS Attains Biosafety Level 2 Compliance at Fairfield, NJ Facility

The Fairfield, NJ facility has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.
/ read more /


Recipharm and LobSor Pharmaceuticals Sign Manufacturing Agreement for Parkinson’s Treatment

This agreement follows a collaboration between both parties for the development and manufacture of Lecigon batches for recently completed clinical trial.
/ read more /


More Supplier News

Industry News

EMA Sets Up Workshop on Orphan Drugs

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
/ read more /


AAPS Announces New Slate of Leaders

Pharma scientists announced for AAPS executive council and section leadership positions.
/ read more /


More Industry News

Regulatory News

Certifying Excipient cGMPs

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available.
/ read more /


FDA Issues Final Elemental Impurities Guidance

FDA publishes the final Q3D Elemental Impurities guidance.
/ read more /


More Regulatory News

FEATURED TOPICS

INGREDIENTS

Going Low Temperature

More complex drug candidates require more specialized and selective chemistry.
/ read more /

TROUBLESHOOTING

Cleaning a Vial Filling Line

Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.
/ read more /

OUTSOURCING

CMOs Concerned With Cost of Single-Use Equipment

Suppliers indicate prices for single-use equipment are likely to increase.
/ read more /

SUPPLY CHAIN

Collaborating on GMP Inspections

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.
/ read more /


Product/Service Profiles

Agilent

Agilent Bio-Monolith Protein Affinity columns
Now with two affinity ligands – Protein A and the new Protein G for IgG molecules which have low bonding affinity for Protein A.
  •   Fast separations to determine titer quickly and accurately on many samples for
      rapid cell culture development and optimization
  •   High binding capacity
  •   Compatibility with a wide range of elution buffers
  •   Long column life
/ Read More /

Shimadzu

Nexera X2 – X-ceptional insights
Ultra-high sensitivity, expanded flexibility, increased stability and robustness – the Nexera X2 UHPLC system targets routine analysis and applications in highly regulated environments demanding complex system setups.
/ Read More /



Event Profile

Pharma EXPO

Winning Solutions for the Entire Pharmaceutical Lifecycle
Pharma EXPO brings together solutions designed to give pharmaceutical, biopharmaceutical, medical device and nutraceutical companies like yours a competitive edge. Plus, the co-location with PACK EXPO Las Vegas provides the opportunity to explore processing and packaging ideas from all other industries.
/ Register now at pharmaexpo.com /


Webcasts

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand

The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon


Building the Future: Using Simulation Effectively

On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by Baxter


more webcasts

on pharmtech tv

PharmTech TV

Blow-Fill-Seal for Aseptic Processes

The Human Element in Pharma Manufacturing

Working with CMOs and CDMOs

Events

PDA/FDA Meeting 2015

September 28–30, 2015 | Washington, DC, USA

BIOTECHNICA 2015

October 6–8, 2015 | Hannover, Germany


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.
/ Click here /


More Reference Library

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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