GMPs for Small-Molecule Drugs in Early Development:
Workshop Summary-Part VI
The authors explore and define common industry approaches and practices when applying GMPs in early development.

DoE Provides Benefits, but Preparation Is Necessary
Defining critical parameters and processing large quantities of data can be a challenge.

Advertisement: Vaisala Mapping Kit: The Quickest Route to Environmental Validation Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study. Compact, rugged loggers are easy to place 10-year data logger lifespan Fast, simple setup 21 CFR Part 11 compliant reporting Comprehensive IQ/OQ Learn more

New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Advertisement: ATCC® Minis provide a convenient, ready-to-use solution for handling pharmacopeial-recommended strains. ATCC® Minis are authenticated and backed by ATCC polyphasic testing – ensuring the same consistent and reliable reference materials you’ve come to trust from ATCC Genuine Cultures®. Use promo code BST114 to save 15% on ATCC® Minis between now and December 31, 2014 (U.S. only; restrictions apply)! Order now at. www.atcc.org/minis

Roche Adds Non-Invasive Prenatal Testing to Pipeline with Ariosa Acquisition
Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.

Advertisement: Developing a Comprehensive Tool Kit for Microbial Identification November 18, 2014 at 11:00 AM EST Click here to Register free.

FTC Announces Conditions on GSK and Novartis Joint Venture Agreement
The US Federal Trade Commission will require Novartis AG to divest its nicotine replacement therapy patch business to continue the joint venture with GlaxoSmithKline.

Dalton Launches Steriles Made Simple Programs
Dalton Pharma Services announced the launch of Steriles Made Simple programs to produce clinical sterile liquid injectables more quickly.

Hovione Files First IND with FDA for New Topical Formulation of Acne Drug
Hovione has filed its first investigational new drug (IND) application with FDA for minocycline gel, a new topical formulation using a patented crystalline base form.

India—A Force to be Reckoned with in Pharmaceutical Manufacturing
Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

Medtronic Gains US and EU Conditional Approval for $43 Billion Acquisition of Covidien
Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

Bosch Joins Forces with Indian Cleanroom and Pharmaceutical Machinery Supplier to Extend Global Reach
Bosch Packaging Technology, a specialist in processing and packaging equipment, has signed a joint venture agreement with Indian supplier of cleanrooms and pharmaceutical machinery, Klenzaids Contamination Controls.