Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.

A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.

The Russian pharmaceutical company PharmaStand finalizes deal for acquiring Bever, a Singapore pharma company.

Eisai files a petition with federal appeals court to require the Drug Enforcement Agency to put anti-epilepsy drug Fycompa on the controlled list of substances.

Sangamo BioSciences has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus (AAV) gene therapies.

Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Akorn will acquire Hi-Tech Pharmacal for $640 million.

AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Siegfried is proceeding with its expansion in China and Switzerland.

Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.

Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.

Vical's restructuring will leave the company with approximately 74 employees.

Top four graduate students to be hosted at GE Healthcare Life Science's Uppsala site.

Andrew Derodra will join Skyepharma in the fourth quarter of 2013.

Takeda Peru will be headquartered in Lima and will be responsible for sales and marketing of Takeda's products in Peru.

Parameter Stability Storage adds validated space in anticipation of pending contracts.

The MHRA has issued a warning to the public not to use unlicensed traditional Chinese medicines after discovering that some of them contain dangerously high levels of lead, mercury and arsenic.

Experts, including researchers at I Holland, Natoli, and Rutgers University’s Engineering Research Center for Structured Organic Particulate Systems, are seeking a greater understanding of the fundamental causes of tablet sticking and are developing predictive models to more quickly find solutions to specific sticking problems.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Companies exhibit developments for pharmaceutical packaging to meet needs, such as e-pedigree and inspection requirements.

Agencies collaborate to ensure consistent product quality.

INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.

FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.

The acquisition expands SeraCare's portfolio of products designed to help diagnostic researchers develop in vitro diagnostic assays.