News

FDA, Arkansas Sign Agreement to Enhance Regulatory Science.

PhRMA has released a statement expressing their opposition to laws that would alter Medicare Part D.

Since China's State Food and Drug Administration revised its GMPs last year, the agency has been making other improvements as well to improve the quality of its pharmaceutical manufacturing industry.

The second quarter of 2011 presented a mixed picture of financing for the life-science sector, which includes the biotechnology and medical-device industries.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Chemineer and IDS.

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

Pfizer has partnered with the University of California's San Diego Health Sciences in a drug discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies.

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.

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.