Generic Drugs Face Regulatory and Scientific Challenges
FDA funds research to further development of innovative generics, while working to address review and approval issues.

Advertisement: Get Your Equipment CLEANER, FASTER! Clean, rinse and dry your manufacturing equipment in minutes! Your cleaning process doesn’t have to be a hassle — get a more thorough cleaning in 3 easy steps. Learn More!

Regulatory Roundup
Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

Advertisement: Nearly 100 global pharmas and consumer healthcare organizations partner with Ropack for contract manufacturing and packaging services. Focused on quality and reliability, Ropack provides bottling, blisters in multiple formats and pouch/sachet filling. Now Ropack also offers stick-pack filling of temperature- and humidity-sensitive products in a controlled environment.  Stick-pack, particularly for pediatric applications, is ideal for reformulation and patent protection. (513) 846-0921; paul.dupont@ropack.com Live Link: Ropack.com

Seeking Harmonization in Nanomedicines Regulatory Framework
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Advertisement: 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. Get your copy now

FDA Issues Final Guidance for Oversight of Clinical Investigations
The guidance describes a risk-based approach to monitoring of clinical trials.

Advertisement: Engineering Solutions to Solve Challenges in Pharmaceutical Processing: Powder Handling Live Webcast: Wednesday, September 11 at 11:00 am EDT. Register Free at www.pharmtech.com/solutions

Adamis Pharmaceuticals Licenses 3M's Dry Powder Inhaler Technology
Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

Advertisement: Safe Automated Weighing of Potent Compounds in the Pharmaceutical Industry Live Webcast: Tuesday Sept 17, 2013 at 11:00 EDT, 15:00 UTC. Register Free at www.pharmtech.com/potent

LSNE Successfully Completes MHRA Inspection
Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.

Oncobiologics and InVentive Health Clinical Form Biosimilars Pact
The companies initially focused on five biosimilar products.

Lonza Licenses Gene Expression Technology to Sorrento
The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

VIVUS Forms Commercial Supply Agreement with Sanofi
Sanofi Chimie will supply the API avanafil for VIVUS.

Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme for Niemann Pick Type B Disease
Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.

ScinoPharm, Sundia MediTech Partner for Pharma Outsourcing in China
ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.