
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA clarifies stability data recommendations for abbreviated new drug applications.

Garvey's vial-drying system and pressure-less accumulator reduces drying time and decreases the risk of vial damage.

Eurofins Scientific will acquire ViraCor-IBT Laboratories for $255 million.

KBI Biopharma acquires Merck's microbial process development and manufacturing operations in Colorado.

Shire expands rare disease portfolio with acquisition of Lumena Pharmaceuticals.

AstraZeneca's Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.

The Fogarty International Center, a component of the US NIH, calls for a focus on noncommunicable diseases and implementing science in low-resource settings.

A multi-institutional effort will fight pediatric leukemia and neuroblastoma.

FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.

The Pediatric Clinical Research Group initiative expands to include pediatric research sites.

Bayer will acquire the consumer care business of Merck & Co., and enter a co-commercialization agreement in the field of sGC modulators.

MPI Research, inviCRO, and 3D Imaging open its new Translational Imaging Center in Michigan.

Ash Stevens receives the 2014 Lilly Global Supplier Award.

Pharmatek develops two new cGMP manufacturing suites for API-in-capsule productions.

Janssen Pharmaceutical collaborates with Stop TB Partnership's Global Drug Facility to increase access to anti-TB compound.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

AstraZeneca rejects $106 billion offer; Pfizer states its case for the merger with British government.

WHO report provides a comprehensive picture of antibiotic resistance and suggests strategies to fight resistance.

Bristol-Myers Squibb is named No. 1 on 2014 Best Corporate Citizens List for the third time in six years.

The Azzur Group and BioSPEQ merger will increase consulting services and project resources within the life-sciences industry.

Eli Lilly has developed the Lilly Medical Student Intern Program for future physicians.

Changes are needed to maintain US biopharma innovation leadership.

Novartis' eBook features images of meningococcal disease survivors from around the world.

Shire acquires Fibrotech for $75 million.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

USP releases new and revised standards for organic impurities in medicines for public comment.

BMS acquisition of iPierian advances BMS' pursuit of therapeutics for genetically defined diseases.

Agenus and Merck work together to advance immune-oncology programs.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.