News

Croatia is on track to join the EU in 2013 and offers a well-developed pharmaceutical market. However, its EU membership application has undergone much scrutiny.

There have been several new stories and reports lately that paint a rather gloomy picture of the state of pharma R&D.

AstraZeneca Receives FDA Approval for Brilinta; Sanofi Makes Several Senior Appointments; and More.

Bristol-Myers Squibb has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases, for $325 million.

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand.

The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a World Health Organization presentation.

FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER's strategic planning in the years ahead and allow it to fulfill its regulatory mission.

The age of globalized industry should result in fewer barriers between countries, but in practice it is rarely that straightforward, according to a report by ScienceInsider.

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use.

According to a price report by Medecins Sans Frontieres (MSF, or Doctors Without Borders) released July 18, 2011, several pharmaceutical companies have withdrawn drug price reductions in so-called middle-income countries, such as India, Indonesia, Thailand, Vietnam, Ukraine, Colombia and Brazil.

The DHS announced it has revised tiering assignments for several chemical facilities covered under DHS's Chemical Facility Anti-Terrorism Standards program, which requires chemical companies to develop and implement specific security plans for their facilities.

FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.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