News

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.

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FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the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

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

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

FDA Publishes Final Guidance on Dissolution Testing.

Roche Establishes R&D Institute in France; Sanofi Appoints Peter Guenter as Senior Vice-President, Europe; and More.

President Obama unveiled an Advanced Manufacturing Partnership designed to reinvigorate the country's manufacturing sector.

Industry analysts have highlighted the pharma industry's high rate of Phase III drug terminations and significantly reduced R&D spending.

The IPEC Federation has issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan.

The European Medicines Agency (EMA) has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation's execution.

The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.

FDA Issues Warning Letter to Dr. Reddy's Following Inspection of the Company's Mexico-Based API Manufacturing Plant.

The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study.

FDA released a new strategy on that is aimed at meeting the challenges posed by rapidly rising imports of FDA-regulated products and the growing complexity of the pharmaceutical supply chain.