News

FDA Issues Final Guidance Regarding cGMPs for PET Drugs.

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. FDA has also reached a similar conclusion based on the findings.

The Society for Chemical Manufacturers & Affiliates commented on EPA's modifications to the Inventory Update Reporting rule, also broadly know as the Chemical Data Reporting rule. EPA issued the final rule earlier this month.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

Catalent Expands Global Cold-Chain Supply Operations; Nycomed US Names Brian A. Markison as CEO; and More.

GlaxoSmithKline is among the companies building scientific capacity to address diseases in the developing world.

FDA announced in late July the 2012 user fees collected under the Prescription Drug User Fee Act of 2007.

EPA's Presidential Green Chemistry Awards recognize developments in green chemistry, including those in pharmaceutical applications.

Merck & Co. announced last week that it plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company made the announcement as part of its second-quarter earnings release, which the company issued on July 29, 2011.

McNeil-PPC Lowers Maximum Daily Dose for Single-Ingredient Acetaminophen Products Sold in the US; Sanofi Names David-Alexandre Gros as Chief Strategy Officer; and More.

The International Society for Pharmaceutical Engineering published a guidance document that defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.

The US Agency for International Development, the government of Norway, the Bill and Melinda Gates Foundation, Grand Challenges Canada, and The World Bank partner to bring innovative solutions to improve maternal and children’s health in the developing world.

FDA Website Provides Information on Drug Shortages.

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

Companies in the life sciences industry are struggling to accurately predict their spending for clinical development, according to a survey conducted by US-based software provider ClearTrial.

NIH leads new international consortium to develop a diagnostic tool for most known rare diseases by the year 2020.

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.

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.