News

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.

Contract manufacturing organizations throughout Asia are increasing their capabilities to meet market demand and attract foreign investment and partnerships.

Are biosimilars the next big thing or just the next big bubble?

Visiting a new site or going down memory lane may not get you where you want to go.

New studies reveal the promise and feasibility of transdermal vaccine delivery.

Quality management requires more effort in a complex supply chain.

USP promotes horizontal standards for biologics' quality attributes.

Supplier differentiation is increasingly important in the highly competitive arena of pharmaceutical outsourcing.

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.