News

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.

Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.

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.

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

Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.

This collaboration is said to be the first established between the Crick and a pharmaceutical company.

The investment will help strengthen biotech spin-offs from the United Kingdom’s leading research-intensive universities

The company has doubled its pharmaceutical sciences capacity through the acquisition of a second GMP manufacturing facility and the construction of new formulation development and pharmaceutical analysis laboratories.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.