Drug Development

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

Eight new projects will focus on the diverse needs of the Ebola epidemic, such as new vaccine development, production and distribution, and new diagnostic methods.

Boehringer Ingelheim announced that it would collaborate with Yale University to research novel therapeutic targets in immune-modulation.

NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.

Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.

Tocophersolan or TPGS was developed 60 years ago as a water-soluble form of vitamin E. The author gives an overview of TPGS, including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.

Changing dynamics of the pharmaceutical industry are driving demand.

New designations lead to faster drug approvals, but there is more work to be done.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

This year’s Drug Delivery & Formulation Summit included discussions on solubility, drug penetration, and new approaches to technology.

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

FDA approves treatments for new diseases and drugs that operate by new mechanisms.

On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Selected new technologies, products, and facilities from CPhI Worldwide 2014 are reviewed.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.