Pharmaceutical Technology ePT Weekly
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PharmTech
December 15, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

In this issue

Spending on Medicine to Reach $1.5 Trillion

Sanofi, JHL Biotech Launch Biologics Alliance

FDA Cites API Facility in Barcelona

Top Stories

Novartis, Kite Release Positive CAR-T Data

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.
/ read more /


Something for Everyone in “Cures” Package

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.
/ read more /

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EXPERT INTERVIEW

Rajesh M. Dave, distinguished professor at the New Jersey Institute of Technology, sat down with Pharmaceutical Technology to discuss polymer thin films for drug delivery.

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Industry News

Global Spending on Medicine Predicted to Reach $1.5 Trillion by 2021

QuintilesIMS forecasts global spending on medicine will reach $1.5 trillion by 2021.
/ read more /


FDA Cites API Facility in Barcelona for Deviations from CGMP

FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.
/ read more /


More Industry News

Supplier News

Charles River to Offer CRISPR/Cas9 Genome Editing

Through a license agreement with the Broad Institute, Charles River Laboratories will now be offering gene-editing engineering technology.
/ read more /


Saneca Invests in API Manufacturing R&D

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.
/ read more /


More Supplier News

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Guidelines and Regulations for cGMP Mapping

There are 5 different guiding and regulating agencies for cGMP mapping processes. This document summarizes the agencies and the specific articles that should govern your mapping project in warehouses, production facilities, rooms and chambers.
/ Download the document (PDF file) /

Bio/Pharma News

Sanofi, JHL Biotech Launch Biologics Alliance in China

JHL Biotech and Sanofi collaborate on the development and commercialization of biological therapeutics in China.
/ read more /


More Bio/Pharma News

 

Spark Licenses Selecta's Gene-Therapy Administration Technology

Spark Therapeutics and Selecta entered a license agreement for Selecta's gene-therapy co-administration technology.
/ read more /


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Regulatory News

FDA Blog Examines Inspection Expansion in the EU

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA's inspection capabilities in Europe and beyond.
/ read more /

 

FDA Cites API Facility in Barcelona for Deviations from CGMP

FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.
/ read more /


More Regulatory News


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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Best Practices for Cleaning Validation Swab Recovery Studies

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
/ read more /

 

ANALYTICS

Improving Pharma Systems with Process Analytical Technology

Pharmaceutical Technology spoke with Melissa Topp, director of Global Marketing at ICONICS, about the latest in process analytical technology (PAT).
/ read more /


FACILITIES

Deciding When To Use Modular Construction

Different types of modular systems have advantages and disadvantages.
/ read more /

SCALE-UP/TECH TRANSFER

Effective Technology Transfer and Validation Strategies with CMOs

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties.
/ read more /


ON DEMAND WEBCASTS

Advances in Manufacturing Technology Lead to Efficiency, Reliability, Flexibility and Speed to Market
On Demand
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Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
On Demand
Learn more


Risk Management Strategies for Quality Management in the Pharmaceutical Industry
On Demand
Learn more



Events

Peptalk: The Protein Science Week

January 9–13, 2017

Pharmapack Europe

February 1–2, 2017

CPhI North America

May 16–18, 2017

more events

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

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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