EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

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

This move is expected to stimulate the exploration of many more medicines for use in children.

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.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

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

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

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

Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.

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.

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

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

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

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

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

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

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

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

Experts discuss crucial aspects of measuring the stability of biologics, which exhibit greater variability in stability testing than do small-molecule drugs.