News

The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.

CSL Behring announced that it plans to invest $450 million to expand its Melbourne, Australia and Kankakee, Illinois facilities, which will increase production of albumin and plasma intermediates.

ABP 501, a biosimilar candidate for Humira, was shown to have a immunogenicity and efficacy profile comparable to that of the innovator product.

FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.

New investments, expansions, and company rebranding are discussed at CPhI.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

A change in the supply chain for three important Genentech cancer medications elicits a strong reaction from one of the nation's largest operators of hospitals.

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

Delivery of large protein biopharmaceuticals may now be administered orally with the help of microneedles, according to researchers at MIT.

Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.

Nova Bio-Pharma Technologies' new vaccine stability device eliminates the need for cold storage.

Manufacturing drugs from biological sources sometimes can't be rushed, even when a rare disease becomes more widespread.

Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

Baxter International announced it will form a R&D center in Cambridge, Massachusetts for its new biopharmaceutical company, Baxalta.

A new Thomson Reuters BioWorld report outlines the more than 700 biosimilars that are currently in development and the emerging business opportunities that exist in the biopharmaceutical space.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

The Purple Book will list biologic and biosimilar products and will serve as a guide for interchangeability.

NIH continues funding for tissue chips to be used in the development of therapeutics.

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Regulations, product protection, and cost management are top concerns of supply chain decision makers.

Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich.

PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

GSK is found guilty of offering bribes to doctors and is fined $489 million.