News

Cambridge Consultants is developing a low-cost portable instrument to test respiratory drug-delivery devices.

The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration's drug and medical device regulation bar state liability claims.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...

The World Health Organization's World Health Assembly is holding its 61st annual session this week to discuss a number of public health issues, many of which are tied directly to pharmaceutical manufacturing.

The devastating May 12 earthquake that struck the Wen Chuan Sichuan province of China left tens of thousands dead, homes and businesses destroyed, and survivors without basic human needs such as shelter, food, and medicines. The quake also had a significant impact on the local industries of the region. Pharmaceutical companies located within the affected areas are assessing possible damage to facilities and loss of personnel.

PharmTech's monthly newsletter, reviews the Editor's Picks for the May 2008 edition: Watson-Marlow Flexicon and HealthStar

Controlling modular, self-contained process skids (known as plug-and-play components) with an automation system can increase a pharmaceutical manufacturing facility?s flexibility.

Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.

Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...

Once again, the US Food and Drug Administration is under fire for not doing its job. This time the issue is direct-to-consumer (DTC) advertising.

Eli Lilly completed the final and largest phase of a major biotechnology expansion in Indianapolis, Indiana.

Researchers at the University of Southern California's Information Sciences Institute (ISI) demonstrated a way to manufacture miniscule containers called voxels that could potentially deliver precise microdoses or even nanodoses of drugs.

To establish user fees for the 2009 fiscal year, the US Food and Drug Administration is asking pharmaceutical manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16, 2008.

Increased investment by the pharmaceutical and biotechnology majors in offshore early drug development creates opportunities and challenges for outsourcing.

Congress is considering proposing a new chemical policy similar to the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. Batch and custom manufacturers weigh in on the debate.

Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft.

The European community and European Federation of Pharmaceutical Industries and Associations (EFPIA) held its first call for proposals for its five-year, €2 billion ($3.1 billion) initiative to boost biomedical innovation.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.

Florida is making its case for pharmaceutical and biotechnology research and development.

An authoritative book helps drug developers face one of their toughest problems.

Brief pharmaceutical news items for May 2008.

Congress is taking on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Act of 2008.

US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, "Restoring FDA's Ability to Keep America's Families Safe."

Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.