News

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

 The United States Treasury Department introduced policy in September 2014 to discourage companies from merging with foreign companies in another fiscal jurisdiction to escape tax responsibilities. The policy was enacted to make inversion more difficult and to curb a company’s acquisition of a related foreign company for the sole purpose of avoiding United States corporate tax rates.

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

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

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

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

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

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

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

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

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

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

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.

The GPhA-run organization asks regulatory agencies to keep international nonproprietary naming conventions intact for biosimilars.

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

The new column features Natrix’s signature macroporous hydrogel.

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.

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.

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

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).

BioSC Lab is the first in a line of next-generation chromatography equipment for protein purification in batch and continuous modes.