PharmTech Europe, Weekly Alert
Having trouble viewing this e-mail? CLICK HERE
Advertisement

PharmTech Europe

30 June 2015

PHARMTECH.COM

CURRENT ISSUE

SUBSCRIBE

FORWARD

twitter linkedin

Top Stories

CHMP Recommends 10 Medicines for Approval

Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.
/ read more /


European Pharmacopoeia Commission Updates Ph.Eur.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
/ read more /


ICH Appoints New Director of the ICH Secretariat

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.
/ read more /


Subscribe

Subscribers can enjoy each full issue of Pharm Tech Europe in print, or via Pharm Tech Europe apps.

subscription offers
subscribe
advertisement

FOCUS ON EXCIPIENTS

Using a Dual-Drug Resinate Complex for Taste Masking

Box-Behnken modeling was used to optimize a resinate complex to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.
/ read more /


Using Polymers for More Efficient Hot-Melt Extrusion and Spray Drying

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.
/ read more /


More on Excipients

FOCUS ON APIs

Analytical Techniques for Oral Solid Dosage Formulation

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
/ read more /


New Ways Around Hazardous Reagent Chemistry

Safer reagents and reaction conditions are making many hazardous transformations possible.
/ read more /


MORE ON APIs

advertisement

NEWS AND TRENDS

FDA Issues Guidance on Generic Tablets and Capsules

The agency publishes guidance on the physical attributes of generic tablets and capsules.
/ read more /

BPTF Calls for Changes to GDUFA

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.
/ read more /


More News

FEATURED TOPICS

BIO/PHARMA NEWS

Kite Collaborates with bluebird bio to Develop T-Cell Therapy Products

Kite announces that it will collaborate with bluebird bio to develop and commercialize second-generation T-cell receptor product candidates for HPV-associated cancers.
/ read more /

INDUSTRY NEWS

ASCO Task Force Releases Cancer Drug Outcomes Comparative Tool

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results—and costs—of popular cancer medications.
/ read more /

SUPPLIER NEWS

Novasep Plans ADC Facility in France

Novasep’s new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.
/ read more /

STANDARDS AND REGULATIONS

FDA Issues Guidance on Allowable Excess Volume for Injectables

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
/ read more /

SUPPLY CHAIN

EMVO Names Service Providers for FMD Project

The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.
/ read more /

BIOLOGICS

Using mAbs to Access Undruggable Targets

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.
/ read more /


Product/Service Profile


Albany Molecular Research Inc.

Listen to AMRI's on-demand webinar, entitled “Trends in Quality Agreements & Communications: A CMO Perspective”, which was held on Tuesday, June 23, 2015 at 11 a.m. ET.
/ Read more /



Webcasts

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

Tuesday, June 30, 2015, 11 am EDT

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.
Sponsored by: Capsugel


Strategies to Accelerate Early Phase Clinical Trials

Tuesday, June 30, 2015, 11:00 am EDT

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 Life Science Services


more webcasts

on pharmtech tv

PharmTech TV

Smart Supply Chain Management

Trends and Concerns in Capsule Production

Focus on Biobetters, Part 1

Reducing Costs of Drug Manufacturing

Events

29th Annual Symposium of The Protein Society

July 22-25, 2015 | Barcelona, Spain

42nd Annual Meeting & Exposition of the Controlled Release Society

July 26-29, 2015 | Edinburgh, Scotland

PACK EXPO Las Vegas 2015

September 28–30, 2015 | Las Vegas, NV USA


more events

REFERENCE LIBRARY

Pharmaceutical Technology presents its 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. / Click here /


More Reference Library

eBOOKS

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.


more ebooks
contribute | CONTACT EDITORS | CONTACT SALES | subscribe | advertise