
African Community Joins ICH's Steering Committee.

African Community Joins ICH's Steering Committee.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a number of press releases on Aug. 25–26, 2011, regarding the discovery of rogue medicines in packs of Reckitt Benckiser's Nurofen Plus.

To further enhance its position in clinical-trial materials supply, Catalent Pharma Solutions has agreed to acquire the clinical-trial supplies business of Aptuit for $410 million on a cash and debt-fee basis.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

Eisai Establishes New Pharma Sales Subsidiary in Mexico; Cangene Names John A. Sedor as President and CEO; and More.

In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics.

GlaxoSmithKline has taken a stake worth £1.25 million ($2.06 million) in its biotech spin out company, Autifony Therapeutics, which aims to develop new treatments for hearing disorders.

The UK government announced that a record £800 million ($1.32 billion) in funding would be set aside for translational research to boost the development of medicines, treatments, and care for patients, particularly in the fields of cancer, diabetes, and heart disease.

FDA released a strategic plan to advance regulatory science on Aug. 17, 2011, in an effort to "keep pace with and utilize...new scientific advances," and to promote public health. The plan is based on the agency's five-year strategic goals and its October 2010 report on advancing regulatory science.

Bayer HealthCare has agreed to support the Stop TB Partnership in the fight against multidrug-resistant tuberculosis by making 620,000 tablets of the antibiotic moxifloxacin available to WHO.

Xcelience Expands its Facility in Tampa, Fla.; Delta Pharma Names John Ebeid as VP of Outsourcing; and More.

In its latest filing with SEC for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and DOJ with information concerning potentially improper payments made by Pfizer and Wyeth in connection with sales activities that took place outside of the United States.

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.