Provider Demand to Drive Compounder Registration with FDA
FDA is moving fast to implement the drug compounding provisions of the new Drug Quality and Security Act, issuing guidance to spur registration by outsourcing facilities.

President Obama Signs Drug Quality and Security Act
Drug Quality and Security Act gives FDA authority over compounding pharmacies.

Predicting Long-Term Storage Stability of Therapeutic Proteins
Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.

Applying Catalysis to Optimize API Synthesis
Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

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Solvent-Free Coating of Traditional and User-Friendly Dosage Forms
The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.

Video: Lilly Strategy: Timely, Valued Medicines to Patients
Dr. Jan Lundberg, EVP science and technology and president Lilly Research Labs, Lilly & Co., sits down to discuss the company’s new approach to drug development and its Phase III pipeline.

Merck KGaA Invests in Research Partnerships in Israel
Additional companies join Merck KGaA and Neviah Genomics in the Israel BioIncubator.

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Lilly Funds Start Up of Biosciences Research Institute
The Indiana Biosciences Research Institute will accelerate collaboration and focus on human-health solutions.

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Scientists Discover New Drug Target for Malaria
Novartis reports on the discovery of phosphatidylinositol-4 kinase (PfPI4K) as the target of a class of experimental antimalarial drugs called the imidazopyrazines, which has the potential to prevent, block, and treat multiple stages of the malaria lifecycle.

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Baxter Recalls One Lot of Nitroglycerin in 5% Dextrose Injection
Baxter has issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

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USP and Other Organizations Unite in Campaign to Raise Awareness of Counterfeit Medicines
The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

EMA Workshop Seeks to Foster Early Dialogues Between Drug Developers, Regulators, and Payers
EMA hosted a workshop on Nov. 26, 2013, which brought together regulators, health-technology-assessment (HTA) bodies and the pharmaceutical industry to discuss how to generate evidence in drug development and improve medicines access.

Aptuit Appoints New CEO
Aptuit appoints Jonathan Goldman as CEO.

AAPS Foundation to Promote Drug Development
American Association of Pharmaceutical Scientists Foundation to assist current and future scientists.