Articles by Rich Whitworth - BioPharm International

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Articles by Rich Whitworth

Novartis Issues Recall and Suspends Operations at US Facility

Jan 17, 2012

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention.

Pfizer, GSK Commit to Supplying Developing World with Vaccines

Jan 3, 2012

Pfizer and GlaxoSmithKline (GSK) entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis and is one of the leading causes of death in children under the age of five in developing countries.

Therapeutic Vaccine Outlook

Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?
Jan 1, 2012

Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?

FDA-EMA Joint Manufacturing Inspections to Begin in 2012

Dec 20, 2011

The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. The initiative will begin in January 2012, according to a jointly issued press release on Dec. 9, 2011, and will enable the two authorities to rely on each other's inspections outcomes instead of conducting inspections in duplicate

AstraZeneca and MRC form Landmark Collaboration

Dec 13, 2011

In an initiative that could signal a new era in private?public partnerships, AstraZeneca will make 22 compounds available for free to medical researchers next year for projects funded by the United Kingdom?s (UK) Medical Research Council (MRC).

The Employment Outlook Brightens

Readers react to the economic turmoil of the past year and look longingly forward to 2012.
Dec 1, 2011

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

EMA Addresses Globalized Supply Chain Issues with Annex 16 Revisions

Nov 22, 2011

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:

MHRA Drives for Regulatory Excellence

Nov 8, 2011

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011.

EMA Invites Feedback on Biosimilar and Vaccine Concept Papers

Oct 11, 2011

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

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