News

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.

iQur and the Edward Jenner Institute for Vaccine Research announced that that they will receive a grant of 152,000 EUR ($201,523) from the Technology Strategy Board's Biocatalyst fund to develop a novel malaria vaccine.

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.

Pfizer has announced plans to internally separate its commercial operations into three business segments.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.

Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA.

Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.

Adaptimmune has opened a Phase I/IIa ovarian cancer trial to evaluate its genetically engineered T cell treatment, with enhanced antitumor activity.

The report highlights a need for greater third party certification to ensure GMP vigilance.

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.

Molecular Profiles has opened a new clinical manufacturing facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency.

Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.