GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.

Standards for ferrules and cap overseals focus on explicit warnings.

FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

The flexible biomanufacturing system uses single-use technology.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

LSNE appoints Shawn Cain as COO, a new position within the company.

Facility in Germany provides space for evaluating continuous pharmaceutical processing equipment.

EMA revises its polices on fee reductions for orphan drugs for 2014.

Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Scientists can share time and pharmaceutical knowledge with high school students.

SGS Life Science Services announced that its bioanalytical laboratory in Poitiers, France has received GMP certification, following approval from ANSM.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Aptuit appoints Jonathan Goldman as CEO.

American Association of Pharmaceutical Scientists Foundation to assist current and future scientists.

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.

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

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

Baxter has issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

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.

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

The Indiana Biosciences Research Institute will accelerate collaboration and focus on human-health solutions.

Whitehouse Laboratories announces the development of a Container Testing Center to open in 2014.

Catalent opens clinical-trial supply facility in Shanghai, China.

Baxter and Cell Therapeutics enter a licensing agreement to develop and commercialize pacritinib.

Thermo Fisher must divest of cell culture media and sera lines, and other businesses, in purchase of Life Technologies.