News

The systems are designed for the manufacture of oncology products and to research new biotech products.

Association recognizes groundbreaking researchers in the field of pharmaceutical sciences.

Shire-s agreement to acquire ViroPharma will strengthen its rare-disease portfolio.

AstraZeneca will build a new facility in the United Kingdom to produce Zoladex, an injectable prostrate cancer treatment.

Grifols expands and diversifies portfolio with acquisition of diagnostic business.

Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.

Former President Jimmy Carter and Pfizer mark milestone for long-standing partnership to combat trachoma in the developing world.

Generic Drug Super Office Takes Shape

New interactive web tool helps innovators match formulations to drug delivery technologies.

Breakthrough Therapies Raise Manufacturing Issues

FDA Promotes Personalized Medicine

The restructuring will put more than 100 R&D jobs at risk as the company scales back on drug development with the aim of simplifying its business to focus on rare disease.

FDA Moves to Curb Drug Shortages

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.

ISPE names Novartis' US Flu Cell Culture facility as award winner.

Merck Millipore has introduced a new solubility/bioavailability enhancement excipient, Parteck SLC, which has a unique pore structure that enables higher loading of amorphous APIs, thereby, improving dissolution rates and increasing drug solubility.

A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

ISPE's survey is industry's first large-scale effort to collect data on patient experiences with clinical trial materials.

FDA releases guidance on pulmonary tuberculosis drugs.

Pfenex receives subcontract from Leidos to develop a production process for the malaria antigen Plasmodium falciparum reticulocyte-binding homolog 5 (Rh5).

DSM Pharmaceuticals appoints a new business unit director of its DSM Biologics/BioSolutions businesses.

Bend Research adds powder-filling technology.

Novasep?s European manufacturing sites in France and Germany pass FDA audits.

Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists.

Repligen completes expansion of its manufacturing facilities at its Massachusetts headquarters.

EMA and FDA publish joint QbD guidance on design space verification.

DSM Pharmaceutical signs manufacturing agreements with Opthea and Sanquin.

WuXi PharmaTech completed a general GMP and pre-approval inspection from FDA.

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.