Pharmaceutical Technology Editors

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.

FDA Publishes CDER Presentation, and more.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.

US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an "unprecedented" shortage of prescription drugs, especially for chemotherapy.

FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well.

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

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

ICH Unveils New Website and Logo

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.

Equipment and Processing Report talked to Jonathan Seville, dean of the School of Engineering at the University of Warwick, to find out how positron-emission particle tracking could help pharmaceutical manufacturers gain process understanding.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

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

On Nov. 17, 2010, Novartis (Basel) disclosed its long-term business strategy, which emphasizes diversification in what the company described as high-growth healthcare segments.

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

FDA Issues Statement for Consumers about Antibiotic Use

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2010 edition from BinMaster and Silverson Machines.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

PQRI and FDA present Process Drift Workshop, and More.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

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