News

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.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

The JOBS Act and FDASIA show early signs of accelerating drug development.

Jeremy Levin, CEO and president of Teva Pharmaceutical Industries steps down , and interim successor named.

A new report details FDA's role and responsibilities in personalized medicine.

Cambridge Major Laboratories and AAIPharma Services appoints Patrick D. Walsh as CEO of merged company.

Clariant opens its new Clariant Innovation Center in Germany, a hub for R&D research.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A US court of appeals rules on patent litigation for AstraZeneca's asthma drug Pulmicort Respules (budesonide).

Dow Chemical and Cambrex open a new facility for Dow?s hydroxypropyl methylcellulose acetate succinate (HPMCAS).

WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.

Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.

Combined service offers drug development companies efficiencies in time and resource.

GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.