News

Implementing Europe's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program, will require a massive increase in animal testing and cost six times more than previously estimated.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts evaluation organized by the Chinese State Food and Drug Administration (SFDA) and the company is expected to obtain a production license before the week's end.

Later this month, Dr. Barbara Jentges, the managing director at PhACT GmbH, a regulatory consulting and training firm based in Duggingen, Switzerland, will be speaking at the 2nd Vetter Drug Management Leadership Conference in Germany.

An outstanding new book reviews alternative solvents with an eye to sustainable pharmaceutical processes.

A second-generation and green manufacturing process for testosterone provided economic and ecological benefits.

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.

Scientists at Sigma-Aldrich's new Sigma Advanced Genetic Engineering Labs in St Louis (MO, USA) will develop and distribute genetically engineered animal models for use in research.

Eastern Europe's pharmaceutical market is forecast to grow at a CAGR of more than 10% to be worth more than $41 billion by 2014, according to a report from companiesandmarkets.com.

On Aug. 19, 2009, the US Food and Drug Administration opened a new Center for Tobacco Products on the agency's White Oak Campus in Silver Spring, Maryland.

Lonza (Basel) has submitted a non-binding proposal that would see it acquire all of the Restricted Voting Shares of US-based Patheon.

Scientists have modified a tobacco plant to produce a vaccine for norovirus, the viral infection sometimes called the "cruise ship virus."

Researchers at the J. Craig Venter Institute (JCVI), a genomic research organization, reported that they successfully transformed one bacterium into a different strain by transferring the entire bacterial genome of the first strain into a second, related strain of bacteria.

The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations "to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format."

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

Also, USP signed a Memorandum of Understanding with the Permanent Commission of the Pharmacopeia of the United Mexican States, more...

A transatlantic strategic partnership has been struck between California (USA) based enterprise software solution provider ValGenesis and IT integration specialists Systec & Services (Germany).

Researchers from a university in the US are urging the FDA to demand that drug manufacturers state how new medications compare with similar treatments on product labels.

Only 43% of European Chief Financial Officers (CFOs) and Chief Information Officers (CIOs) have tried to calculate the impact of outsourcing on their company, and of those that have tried, only 1 in 5 are confident in their sums, according to a study by Cognizant.

Amcor (Australia) has made an offer of $2025 million for parts of Alcan Packaging (France), including the company's global pharmaceuticals division.

Researchers at the University of Illinois (Champaign) have developed a cancer drug delivery system that reportedly kills target tumor cells, spars 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...

Researchers from the Stanford University School of Medicine in California are urging the US Food and Drug Administration to demand that drug manufacturers state how new medications compare with similar treatments on product labels.

The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry.

India accounts for approximately 3% of the global outsourcing market, which indicates a significant opportunity for growth, according to a report published by Ernst and Young and the Organization of Pharmaceutical Producers of India.

Only 43% of European chief financial officers (CFOs) and chief information officers (CIOs) have tried to calculate the impact of outsourcing on their company, and of those that have tried, only 1 in 5 are confident about their calculations, according to a study by Cognizant, a global business technology company based in Teaneck, NJ.

An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway.

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

Manufacturing methods for new drugs could be made greener and more efficient with the help of marine microbes.

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.