BioPharm International Editors

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.

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

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

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

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.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

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

FDA receives adverse event reports related to calcium gluconate infusions.

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

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

Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.

The guidance describes a risk-based approach to monitoring of clinical trials.

The companies initially focused on five biosimilar products.

Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.

uniQure B.V. announced it has commenced build-out of a 55,000 ft2 US manufacturing plant in Lexington, Mass.

Rentschler Biotechnologie will manufacture GMP material for advanced clinical studies and market supply of Apeiron's lead program, APN311.

The licensed cell line combines BioWa's engineered glycosylation Potelligent Technology with Lonza's GS Gene Expression System.

A loan from the Province of Nova Scotia will support Immunovaccine's clinical studies through 2016.

iQur announced that it has been granted 5 million EUR ($6.6 million) by the European Union Framework 7 fund to develop a universal influenza vaccine.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

FDA releases FY 2014 generic-drug user fees.

EMA restructures organization.

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

Immunocore Limited has entered into a partnership with GlaxoSmithKline for multiple novel targets not addressable using antibody-based technologies.

Genentech announced that the FDA has accepted the company's Biologics License Application for obinutuzumab (GA101).

A new end-user survey of more than 220 physicians and 650 patients by Frost & Sullivan finds that regardless of disease area, physicians select drug delivery methods that drive consistent patient compliance and effective outcomes.

UK government review will look for unnecessary regulatory burdens and inconsistencies and at guidance clarity.

Bashir Hansraj appointed as Global Technical Director, and David Ross and Sven Thomas appointed as business development managers

13 full members with expertise across the entire pharmaceutical supply chain.