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.

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.

Cobra Biologics installs a new single-use bioreactor to expand its antibody GMP production capacity.

Thomas Engineering names David Decker as the new director of European operations.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

ISPE will discuss FDA’s recent draft guidance on breakthrough therapies at its 2013 Annual Meeting.

PharmaCell will become the European CMO for Dendreon for the commercial production of its cellular immunotherapy product Provenge.

Gentium receives marketing authorization for Defitelio (R) for the treatment of severe hepatic veno-occlusive disease.

Ganymed Pharmaceuticals receives orphan drug designation from FDA and EMA for IMAB362 for the treatment of pancreatic cancer.

CDER recommends reclassifying opioid products as Schedule II.

IDT Biologika and Oncotec Pharma Produktion to expand vaccine and oncology capacity.

SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

CPhI recognizes innovation in formulation, process development, and packaging.

IBEF and Pharmexcil report the country?s plans for growth and its commitment to lowering the cost of medicines globally.