News

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

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

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

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CDER withdraws some outdated guidance documents and makes plans to finalize others.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

Amgen, Servier collaborate ivabraline and other cardiovascular products.

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.

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.

Designation granted by FDA for the treatment of trigeminal neuralgia.

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.