Drug Development

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

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in August 2009.

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

The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week.

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

Brief pharmaceutical news items for September 2009.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

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

Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates.

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.

A Project Manager's Perspective.

Scientists from DSM and Kaneka discuss various techniques in this roundtable moderated by Patricia Van Arnum.

The authors describe the various available technologies used in orally disintegrating tablets.

Combination products have been researched and administered for many years, some successfully and others not.

Combining drugs with synergistic mechanisms of action yields some indisputable benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few.

Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.

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

Researchers at the University of Illinois (US) have developed a cancer drug delivery system that reportedly kills target tumour cells, spares healthy cells and has effects that can be reversed to halt potentially hazardous side effects.

Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...

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

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD -Aegis Whitepaper

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

Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.