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.

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.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.

The agency requires early notification of potential drug shortages.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

CDMO for semi-solid and liquid manufacturing realigns operations at Texas facility.

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.

Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States.

Senators encourage the repatriation of offshore funds in a new report targeting the pharmaceutical industry.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.

Vacuum-conveying conditions for powders and other free-flowing solid forms can be simulated in Volkmann's new laboratory.

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.