Pharmaceutical Technology ePT Weekly
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PharmTech
September 22, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD
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in this issue

EMA Stops Imports from US Company
GE Healthcare Invests in Ireland
Combination Products Create Challenges

Top Stories

GSK Appoints Emma Walmsley CEO

Walmsley will succeed Andrew Witty as CEO of the British drug maker.
/ read more /


FDA Approves First Drug for Duchenne Muscular Dystrophy

The agency granted accelerated approval to Sarepta's controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.
/ read more /

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Industry News

EMA Stops Import of Products from US Company

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.
/ read more /


FDA Director Responds to Drug Pricing Concerns

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, clarifies FDA's role in drug pricing.
/ read more /


More Industry News

EXPERT INTERVIEW

Richard Denk, head sales containment at SKAN, spoke with Pharmaceutical Technology about trends in handling high potency APIs.

WATCH NOW
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Supplier News

GE Healthcare Invests in Ireland Biopharma Manufacturing Campus

GE Healthcare's GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.
/ read more /


Merck KGaA Joins the DiViNe Project

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.
/ read more /


More Supplier News

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Struggling to Maintain Quality Oversight?
Gain greater end-to-end control with harmonized operations. Read the five steps to align quality globally for faster, fact-based decision making and compliance readiness.
Learn How



Bio/Pharma News

Adaptimmune Enters into Manufacturing Agreement with PCT

Adaptimmune entered into a manufacturing agreement with PCT for the manufacture of its SPEAR T-cell therapies.
/ read more /


Allergan to Acquire Vitae Pharmaceuticals

Allergan will acquire Vitae pharmaceuticals for $639 million.
/ read more /


More Bio/Pharma News
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Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
Live Webinar: Wednesday, October 26 at 11am EDT
Register now



Regulatory News

EMA Recommends Breast Cancer Treatment

The agency has recommended marketing authorization for Ibrance in the European Union.
/ read more /


Combination Products Challenge Regulators and Manufacturers

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
/ read more /


More Regulatory News
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Strategies for IND Filing Success
Live Webinar: Friday, October 21 at 11:00am EDT
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FEATURED TOPICS

STANDARDS & REGULATIONS

Common Deficiencies in ANDAs for Dermatologic Drug Products

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
/ read more /

MANUFACTURING

New Directions in Modular Manufacturing

Industry experts discuss recent trends in modular manufacturing.
/ read more /


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Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Live Webinar: Tuesday October 11 at 11am EDT
Register now



QUALITY

Taking a Closer Look at Parenteral Contaminants

Visual inspection of parenteral vials is the first step in a root cause investigation.
/ read more /

FORMULATION

De-activating the Ticking Bomb of Brain Diseases with Nanomedicines

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
/ read more /


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Don't Let Your Diluent be the Weakest Link in Your Drug Product
Live Webinar: Thursday, October 13 at 10:00am EDT
Register now



AAPS Planning Guide

Fette Compacting America's New FE75 Tablet Press

The FE75 double-sided rotary tablet press is equipped with up to 115 punch stations to produce more than 1.6 million tablets/hr.
AAPS Booth # 1133
/ Learn more /

Qualicaps

Qualicaps is a global manufacturer of empty pharmaceutical capsules and pharmaceutical processing equipment.
AAPS Booth # 827
/ Learn more /

Lubrizol Life Sciences

Lubrizol LifeSciences is a healthcare solution partner for medical and pharmaceutical manufacturers who need product development support and combination device solutions.
AAPS Booth # 1127
/ Learn more /


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Getting the Full Picture Predicting Protein Stability Using Chemical and Thermal Denaturation
Live Webinar: Thursday, September 28 at 11:00am EDT
Register now



Events

13th Confocal Raman Imaging Symposium

September 26–28, 2016

CPhI Worldwide

October 4–6, 2016

Global Conference on Pharmacy and Pharmaceutical Sciences Education

November 7–8, 2016

more events

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Enabling Formulation of Water-Soluble and Water-Insoluble Molecules Using a Lipophilic Salt Approach
Live Webcast: Tuesday, September 27 at 11:00 EDT
Register now



REFERENCE BOOKS

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 /

More Reference Library

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.


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