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Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

The new Argos biomanufacturing facility in North Carolina will include automated production using the company's Arcelis technology.

The company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

New research will focus on a superfamily of protein receptors linked to various diseases.

The divestment will create the number two player in the global influenza vaccine industry.

Two lots of empty intravenous fluid bags were voluntarily recalled because of the presence of particulates.

GSK's investigational Ebola vaccine is in Phase I safety trials.

Shire announces it will expand its orphan drug portfolio and is ready for future M&A discussions.

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an ebola vaccine.

Celgene expands its oncology drug discovery and development portfolio through a new partnership with Sutro.

The latest Ebola epidemic sheds light on the delicate processes surrounding the manufacture of genetically modified live cells for biopharmaceutical production.

Unum Therapeutics raised $12 million in Series A funding for its development of antibody-coupled T cell receptors (ACTRs) for the treatment of nonspecific tumor cells.

Secukinumab is the first IL-17A inhibitor to meet its primary endpoint in two Phase III trials for patients with ankylosing spondylitis.

Pall ForteBio introduces a solution for quantifying residual host cell proteins in CHO cells.

The renovation to Roche's historic office building in Basel, Switzerland will feature sustainable workplaces and a state-of-the-art research center.

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

AbbVie to pay Shire $1.636 billion break fee for terminating purchase agreement.

The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Las Vegas last week.

A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen's in the market.

FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.

Lilly announces the closure of its Guayama, Puerto Rico manufacturing facility amid continued investments at other plants.

The new service offering will help customers determine levels of permeability, transport, metabolism, and toxicity in drug product.

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

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.