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Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational Efficiency
Sponsored by Sparta Systems

New Strategies for Evaluating BioPharmaceutical Stability
Sponsored by ABC Labs

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Events

Pharma Trials World Korea 2013
July 8-11, 2013
South Korea

DCAT's Sharp Sourcing 2013
July 11, 2013
New York

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Pharmaceutical Technology Drug Delivery Guides
A three-volume set of drug delivery system handbooks. A compilation of articles on methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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June 27, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE





News

Prepare for Serialization Now
While some companies have delayed taking action on serialization because federal track-and-trace legislation is not yet in place, implementation deadlines in California and around the world are approaching.
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Industry Perspectives: Achieving Solutions for the Challenge of Poorly Water-Soluble Drugs
A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.
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Measuring Tablet Hardness: A Primer
Crushing, fracturing, and bending tests quantify hardness.
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Drug Approval Trends Don't Extend to CMOs
Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.
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News

2013 CPhI Pharma Awards Now Open
Entries open to any company across three categories - formulation, process development and best packaging.
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FDA Grants Breakthrough Status to Novartis Investigational Drug
Serelaxin, to treat acute heart failure, is the second Novartis drug to get new designation from FDA.
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Advertisement:
Pharmas and consumer healthcare organizations can benefit from the increased product safety, compliance, cost-savings and marketability offered by stick-pack packaging of Rx and supplements. Read "Stick-pack Benefits for Pharmaceuticals and Nutraceuticals," a whitepaper by Ropack's Paul Dupont. Visit www.ropack.com to learn more about Ropack's $9M, 15,000-sq-ft facility dedicated to stick-pack packaging of temperature- and humidity-sensitive products. (513) 846-0921. paul.dupont@ropack.com.

Sandoz Launches Phase III Clinical Trial for Biosimilar Etanercept
Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.
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EC Fines Lundbeck Over 'Pay-for-Delay' Deals in Europe
Lundbeck and eight other pharmaceutical companies have been fined for delaying generic entry of the blockbuster antidepressant, Celexa (citalopram), into the market.
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Support and Solutions from Agilent for Impurity Profiling: New Genotoxic Impurities Primer
Agilent partners with Pharma for great results.Download or request a hard copy of our new guide, Genotoxic Impurities in Pharmaceutical Products:  Regulations and Analysis, authored by Ludwig Huber.  The guide provides specific guidelines for genotoxic impurities and recommendations for implementation according to EMA and FDA guidelines.

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NIH Funds Projects to Identify New Uses for Existing Compounds
NIH awards $12.7 million for collaborations between nine academic research groups and pharmaceutical industry partners to explore new treatments.
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Nexera X2 UHPLC/HPLC Series
Shimadzu’s Nexera X2 delivers superior, real-world performance across a wider application range while delivering unparalleled flexibility and reliability. Nexera X2 systems feature clean, ultrafast autosamplers, a new PDA detector, and automated solvent blending and method scouting. In addition, Nexera X2 systems can be configured with a variety of solvent delivery units and column ovens to meet any laboratory workflow.Learn more

PhRMA, BIO Join Coalition Advocating for Fair Trade with India
The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.
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Advertisement:
Ligand’s Captisol® platform technology is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol® has enabled six FDA approved products, including Pfizer’s VFEND® IV and Onyx Pharmaceuticals’ KYPROLIS®. Please visit www.captisol.com. For licensing opportunities please contact Captisol Customer Service at (877) 575-5593.


News

Stanford University Team Wins Award for Drug-Delivery Catheter Design
Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.
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Rexam Healthcare Expands Manufacturing for Drug Delivery Systems
New production capabilities in Normandy, France will include a cleanroom.
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RAME-HART Technology Helps Boost Vaccine Production in Emerging Markets
Semi-automatic technology aids egg-based influenza vaccine production in smaller facility footprints.
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Johnson & Johnson Opens Partnering Office in London
The move is part of a strategy to cultivate innovation in key regions.
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Survey
Outsourcing Trends for the Pharmaceutical and Biopharmaceutical Industries Summary: The editors of Pharmaceutical Technology seek your feedback on trends for contract services for manufacturing, research, and related support. If you are from a pharmaceutical/biopharmaceutical company or contract service provider, please complete this brief confidential editorial survey.

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Advertisement:
Overcoming Challenges in Development of Oral Enteric and Controlled-Release Dosage Forms
Live Webcast: Thursday, July 18, 2013 at 11:00 am EDT
Click Here to Register Free.
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