Randi Hernandez

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.

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

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.

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.

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.

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