News

Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

Sanofi Pasteur and Immune Design agree to jointly develop therapies through Phase II clinical trials.

BioReliance has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services its service offering. The company?s range of predictive assays use a novel suite of genetically modified cell lines created with CompoZr zinc finger nuclease (ZFN), a Sigma-Aldrich proprietary technology.

AbbVie sends Shire notice that it is reconsidering its offer recommendation.

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

A report from PhRMA highlights how drugs that failed in clinical trials are a crucial part of development for melanoma, lung cancer, and brain cancer.

Endo will acquire Auxilium Pharmaceuticals in a cash and stock transaction for approximately $2.6 billion.

CPhI released Part 3 of its annual industry report featuring three experts in the pharmaceutical industry.

The Apollo platform can be used throughout a product?s entire lifecycle.

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.

New rules from the Treasury Department regarding inversion affect merger activity in the pharmaceutical sector.

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.