News

Eggs from Transgenic Hens Express Interferon Beta-1a Protein

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and was well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

Cell-Grown Vaccine Protects Against Avian Flu Virus

Non-Injectable Insulins Win Approval: Pfizer in the US, Generex in South America

The European Science Foundation (ESF) has published the conclusions of its 2-year Forward Look Study on Nanomedicine. Defined as a billionth of a metre, a nanometer is 1000 times smaller than the width of a human hair. Nanomedicine uses nanoscale technology to diagnose and treat disease. The scope of the study included defining the field of nanomedicine, reviewing what has been achieved so far, determining Europe's strengths and weaknesses, and drawing up plans to ensure continued growth.

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.

FDA Unveils New Prescription Drug Information Format

AAIPharma Moves Ahead with Reorganization Plan

FDA Eases Phase I Manufacturing Requirements

Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

Pfizer Combats Counterfeiters with RFID

FDA Issues Dispute–Resolution Guidance

Novartis Considers Acquiring Berna Biotech

Schering-Plough Meets FDA Deadline for CGMP Improvements

Sanofi Pasteur and BD Team Up to Produce Microneedle Vaccines

Hubert J.P. Schoemaker Dead at 55

The benefits of zero tolerance as a test criterion have been oversold. A critical examination of zero tolerance reveals that many of the supposed benefits are not attainable. More important, inappropriate application of this criterion can have a deleterious effect on the assessment, control, and improvement of the quality of pharmaceutical products.

Recent EU legislation change has opened the door for UK firm Accentus to use its novel predictive crystallization technology to discover and develop generic alternatives to patented drugs. Accentus will also licence its CrystalGEM predictive crystallization technology to generics manufacturers.

Pharmaceutical industry regulation is about to change with a new code of practice. This has been revealed by the Association of the British Pharmaceutical Industry (ABPI) following recent problems with patient safety and the dissemination of data and information of approved drugs, which exposed loopholes within the code.

Merck (Whitehouse Station, NJ, www.merck.com) has revealed the "first phase" of its global restructuring program set to eliminate 7000 jobs (11% of its global workforce) by the end of 2008, close or sell 5 of its 31 manufacturing facilities, and roll out a manufacturing strategy to "drive significant efficiencies, decrease headcount, and reduce or refocus operations throughout the plant network and the entire manufacturing division." The company also expects to close one basic research site and two preclinical development sites.

Amgen Losing Hold on Anemia Drug Market

Bristol-Myers Squibb to Cut Costs by $500 Million

Roche Selects 12 Potential Manufacturing Partners for Tamiflu

SEC Loosens Revenue-Recognition Rules for Vaccine Stockpile Participants

NIAID Boosts Vaccine Innovation but Draws Controversy

FDA Warns Consumers Against Unapproved, Contaminated 'Miracle II Neutralizer'

From politics to paychecks and downsizings to deadlines-what it's like to work for one of the world's largest industries.

Roche (Basel, Switzerland, www.roche.com) has put a temporary halt on the distribution of the antiviral treatment, "Tamiflu" (oseltamivir phosphate), a neuraminidase inhibitor, to the United States in an effort to deter companies from stockpiling the antiviral for employee use, according to an article in the Oct. 27 edition of The New York Times.

With the prospect of a possible pandemic the Swiss company, Roche, has found sales of its flu drug have rapidly increased but its patent is being questioned. Roche's Tamiflu sales have inflated by 263% in the first 9 months of this year but discussions of patent suspension from several countries and United Nations Secretary General Kofi Annan is pressurizing the company.

The introduction of new measures on advertising and promotional materials for prescription medicines could delay UK launches. The Medicines and Healthcare products Regulatory Agency (MHRA) has admitted that the checks, which have been introduced in response to a Commons' Health Select Committee report, could extend a launch by at least 2 weeks.