A Survey of Postapproval CMC Changes to Generic Drugs
A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

European Union Packaging Safety Features Come into Effect
Manufacturers are taking measures to comply with new package safety rules.

Advertisement: Natoli Engineering Company is an industry leader and expert in manufacturing tablet compression tooling including multi-tip, single tip, micro-tab, exotic shapes, die table segments and more, from various high-quality steels and specialty coatings. In addition to presses, tooling, and machine parts, Natoli offers a comprehensive tableting accessories catalog. We also provide training seminars and tablet press refurbishing. Scientific and Metallurgy divisions offer additional specialized services.www.natoli.com.

Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.

Drug-Diagnostic Development Stymied by Payer Concerns
The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests.

FDA Approves Novartis' Xolair for Rare Skin Disease
FDA approves Xolair (omalizumab) for the treatment of a rare skin disease known as chronic idiopathic urticarial.

Advertisement: Agilent Solutions for Quality by Design Applying QbD principles at every stage of development and manufacturing helps enhance process robustness and prevent failures at late stages. Request or download this new guide that provides information about Agilent solutions to support quality by design implementation

FDA Approves Eliquis to Reduce the Risk of Blood Clots
FDA approves Eliquis (apixaban) for DVT and PE in patients who have undergone hip or knee replacement surgery.

Advertisement: Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities Live Webinar: (US) Tuesday, April 1, 2014 at 10:00 am PDT / 12:00 pm CDT / 1:00 pm EDT (Europe) Thursday, April 3, 2014 at 2:00 pm BST / 3:00 pm CEST To Register Free: www.pharmtech.com/navigating.

Charles River Laboratories to Acquire the CRO Services Division of Galapagos NV
Charles River Laboratories to acquire CROs Argenta and BioFocus.

Advertisement: Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms Live Webinar: Tuesday, April 8, 2014, 11:00am–12:00pm EDT To Register free: www.pharmtech.com/overcomingchallenges

Aesica's High-Capacity Manufacturing Facility in Queenborough Validated for Commercial Production
Aesica has successfully completed the validation of its high-capacity manufacturing facility in Queenborough, UK, for commercial production.

Advertisement: Increase Control over Quality Management Through Strong Supplier Relationships Live Webinar: Wednesday, April 2, 2014, 1:00 pm Eastern US Time To Register free: www.pharmtech.com/relationships

Adocia's Combination Insulin Formulation Shows Positive Results in Phase I/II Trial
Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes.

Advertisement: Meeting USP Good Storage and Distribution Practices in a Complex Supply Chain Live Webcast: Thursday, April 3, 2014 at 9:00 am PDT / 12:00 pm EDT To Register free: www.pharmtech.com/storage

Catalent Increases Investment in Redwood Bioscience
Catalent increases its minority investment in Redwood Bioscience for engineering ADCs.