News

FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.

Amgen Resolves Patent Dispute with Teva; PharmaNet Development Group Names George Scott Vice-President of Bioanalytical Services; and More.

FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season.

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.

The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2011 edition from BETE Fog Nozzle and Continental Disc.

We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?

Members of the public will soon be able to access data in the EudraVigilance database-EMA's central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area.

SOCMA has issued its support this week of the passage of pending free-trade agreements with South Korea, Panama, and Colombia by two Congressional committees.

FDA announced in early July 2011 that it has made progress toward implementing the US Food Safety Modernization Act, which was enacted in January of this year.

Recent trends in the US biopharmaceutical industry suggest this is a pivotal area for potential job creation.

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.

Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.

New Age Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, implements a solar-energy project at its Pennsylvania facility.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

The International Federation of Pharmaceutical Manufacturers and Associations issues a Framework for Action for noncommunicable diseases.

Partners of the UK's National Cancer Research institute (NCRI) have nearly doubled their spend on cancer research in the last ten years.

Sanofi has entered into a research collaboration with the Weill Cornell Medical College in New York to develop new anti-infectives that aim to both shorten the course of treatment for tuberculosis and provide effective therapies against drug-susceptible and drug-resistant strains of the disease.

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.

The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain.

An FDA panel has voted unanimously to withdraw approval for Roche's Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support that the benefits outweigh the risks.

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States market.

Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.

Getting an answer is easy-asking the right question is apparently more difficult.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

GSK Works in Developing Nations to Improve Everything from Research to Roads.

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

US support of regenerative medicine is essential for maintaining a lead on healthcare innovation.

Which route will we take to arrive at a national stem-cell policy?

Switzerland is an important power in Europe's pharmaceutical industry.