Pharmaceutical Technology Editors

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.

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FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.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

Reversible nanoencapsulation technology may make it possible to deliver high molecular weight drugs directly to target cancer cells, increasing efficacy and reducing side effects.

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

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.

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.

The closure will impact 240 employees through a multistage process starting in December 2013.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

Pharmstandard OJSC seeks to bolster its over-the-counter business through acquiring Bever Pharmaceutical.

Amgen, Servier collaborate ivabraline and other cardiovascular products.

Marken's expansion is fully operational to support clinical-trial material supply.

A simple, rapid analytical method for the determination of palladium in pharmaceutical production samples will speed up development and optimization of reactions involving palladium catalysts.

Jubilant HollisterStier added an ampul filling line utilizing a rigid barrier system.

Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.

The expansion adds commercial specialty ligand, capacity manufacturing.

The initiative enables cleanroom and laboratory operators to recycle used protective garments.

The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.