Drug Development

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.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.

AstraZeneca announced a partnership with Pharmacyclics and Janssen for combination trials of MEDI4736 (AstraZeneca) with Imbruvica (Pharmacyclics and Janssen) for the treatment of hematologic cancers.

Spectranetics announced that it acquired Covidien's drug-coated balloon platform, Stellarex, for $30 million.

New practical approaches to the synthesis of complex heterocycles are reviewed.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Measuring syringe plunger force using a texture analyzer instrument.

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

Pharmaceutical Technology Europe spoke with Piero Iamartino, R&D director at Micro-Macinazione, about the role of micronization in pharmaceutical manufacturing.

Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.