News

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Sweden's Medical Products Agency issues a report calling for strengthening environmental standards for pharmaceutical production within the European Union.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Pfizer has completed its cash tender offer for the biopharm company Icagen after extending its initial deadline.

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

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

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

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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

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.

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.