Pharmaceutical Technology Editors

FDA Makes Organizational Changes Within CDER.

GSK, Anacor Expand R&D Collaboration; Xoma Announces Management Changes; and More.

USP Expands Presence in India.

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

Valeant Agrees to Acquire Afexa Life Sciences; Merck KGaA Names Robert Yates President of Millipore Division; and More.

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011.

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.

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.

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.

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

FDA, Arkansas Sign Agreement to Enhance Regulatory Science.

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

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

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?

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.

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

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.

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.

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

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

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.

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.

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.