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The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.

The PD-1 inhibitor was approved as a first-line therapy and for previously treated patients with advanced melanoma.

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

The technology platform measures protein-protein interactions.

Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.

The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.

Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.

The bill would authorize spending of approximately $8.1 billion on transit projects through 2015 while legislators plan a long-term bill that could have implications for the pharmaceutical industry.

Amoun, Egypt's largest drugmaker, will be sold to Valeant for $800 million.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

FDA releases a report that analyses why some diseases are lacking treatment options.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

Sanofi's new business-unit structure focuses on growth drivers.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.

Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

The Mobius 2000-L single-use bioreactor from EMD Millipore offers configurable software, hardware, and single-use Flexware assemblies for suspension and adherent cell-culture applications.