Analytics

Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more...

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more...

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

Brief pharmaceutical news items for September 2009.

After years of promomting QbD concepts, FDA's ready to take action on nonconformers.

As new process validation guidelines emerge, industry needs to reinvent how it releases product.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.

Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...

Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more...

Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

The US Food and Drug Administration and European Medicines Agency (EMEA) launched this week a joint initiative to collaborate on international good clinical practice (GCP) inspection activities.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Brief pharmaceutical news items for August 2009.

Biotech firms must first close the gaps between science and biology on the path toward QbD.

The author of an ambitious book about quality control falls short of reaching his goals.

The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit.

Individuals and companies at the top seem to have no problem short-circuiting their success.

The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies.

The number of alliances between diagnostics companies and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers.

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.

Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...

Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...

Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more...