Author Archive

Rx-360 Goals Get off the Ground

Angie Drakulich PharmTech editorMany companies throughout industry are depending on Rx-360, the international pharmaceutical supply-chain consortium launched last year, to help ease the burden of protecting their ever-lengthening supply chains. Read more »

Keep an eye on that cargo

Angie Drakulich PharmTech editorPharmaceutical supply-chain managers have yet another item to step up their control of: tractor-trailers. A critical part of the delivery of supply, these large trucks have been used by many pharmaceutical companies for years to transport raw materials, ingredients, and final drug products. Cargo theft has always been a concern, but that concern is now growing. Read more »

Federal Spending Freeze Could Threaten Supply-Chain Security

Angie Drakulich PharmTech editorThe economic recession—recovering or not—was bound to affect FDA at some point. In his 2010 State of the Union address, President Obama proposed a spending freeze for US government agencies and programs that are not tied to national security. Entitlement programs such as Social Security and Medicare also would not be affected. “Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don’t,” said the President in his speech. Read more »

GSK Promotes Open Innovation, Help for Developing Countries

Angie Drakulich PharmTech editorHaiti is the only nation in the Latin American and Caribbean region still considered a least developed country (LDC) by the United Nations. After this month’s earthquake devastated the nation of 9.7 million, it has been heartwarming to see hundreds of disaster relief crews and humanitarian organizations respond to the crisis. Pharmaceutical companies have been part of the picture as well—delivering millions of dollars in funds and medicines, either directly to Haiti or through nonprofit organizations. GlaxoSmithKline (GSK) is among the many pharmaceutical manufacturers, including Pfizer, Abbott Laboratories, Amgen, Merck, Eli Lilly, contributing aid to Haiti. Read more »

FDA Bares All

Angie Drakulich PharmTech editorThe US Food and Drug Administration has unveiled the first phase of its Transparency Initiative: a new website called FDA Basics provides the public with detailed information on what the agency does, who works there, and how regulated products are approved for the marketplace. Read more »

Pharma Goes Hollywood

Angie Drakulich PharmTech editorNow that award season is here, it seems fitting that the pharma industry has announced the production of a new film. Wait, did I just write that? Yes, as did a slew of other surprised bloggers this week. Pharma is going Hollywood. Read more »

Swine-Flu Vaccine Recall Only Adds to Panic

Angie Drakulich PharmTech editorAs if the US community isn’t already paranoid enough about the H1N1 swine flu virus and its vaccine, this week, Sanofi Pasteur, the vaccines division of the sanofi-aventis Group in France, recalled 800,000 prefilled vaccines.

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Vetter Development Service Goes Live in Chicago

Angie Drakulich PharmTech editorVetter, a specialist in the aseptic filling of injection systems, opened a new 24,000-ft2 facility in Chicago to manufacture preclinical, Phase I and Phase II clinical batches. The expansions, part of the new Vetter Develoment Services USA Inc., complement the company’s commercial-scale capabilities in Germany. PharmTech Europe Editor Fedra Pavlou, interviewed Peter Soelkner, managing director of Vetter Pharma International GmbH live from the AAPS 2009 show floor in Los Angeles last month. Listen to the podcast here.

See background article, “Vetter Expands Clinical- and Commercial-Scale Operations” by Patricia Van Arnum.

Rx-360 Takes on Europe, Talks to PharmTech in Podcast Series

Angie Drakulich PharmTech editorThe international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. Read more »

Widget Wonderland at FDA–Who Knew?

Angie Drakulich PharmTech editorIn just a few weeks, FDA will hold its public meeting to discuss the use of social media tools in marketing pharmaceutical drug products. (See back story.) The last time the agency held a meeting to discuss these types of items was in 1996 when the Internet’s popularity was growing by leaps and bounds.   Read more »

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