News

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).

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

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.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Gerresheimer sells its glass tubing manufacturing operations to focus on pharmaceutical packaging business.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

The new column features Natrix’s signature macroporous hydrogel.

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.

The 12th Annual Report and Survey of Biomanufacturing is now available.

Colorcon expands its presence in China with a technical service center to serve the northern region.

Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.

SGS Life Science Services expands cGMP chemistry and biotechnology testing facilities in Shanghai.

A 25,000-sq-ft cargo facility at Philadelphia International Airport offers different levels of temperature storage.

Bylo has been selected to lead the GS1 Healthcare US Industry Initiative, focused on driving adoption and usage of GS1 Standards in healthcare.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.