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.

The agreement gives Allergan a foothold in migraine drug development.

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Keith Moore will support Metrics Contract Services as vice president of analytical services.

FDA orders unapproved prescription ear drop products with active ingredients removed from the market.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

Hovione is installing a new large-scale spray-drying unit in Loures, Portugal, specifically designed to handle high potency APIs and a wide variety of organic solvent systems.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

FDA has accepted for review Pfizer’s new drug application for its modified-release formulation of tofacitinib citrate tablets (Xeljanz).

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

The bio/pharma industry enjoys success, but it cannot ignore patient access to medications.

The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.

CPhI is calling on all its attendees, exhibitors, and the wider pharma community to support this initiative.

The Latvian government and Pharma have signed a letter of intent on June 29, 2015, agreeing on measures and a mutual cooperation in projects that will help improve medicines access and health outcomes in Latvia.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.

Eric Langer, Managing partner at BioPlan Associates, speaks with Pharmaceutical Technology about emerging trends in cell therapy.