News

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.

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.

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.

IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

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