An Evolving Marketplace at CPhI

Patricia Van Arnum PharmTech editor
While attending CPhI Worldwide, a large exhibition of contract manufacturing organizations (CMOs) of active pharmaceutical ingredients (APIs) and intermediates and fine-chemical suppliers, in Paris this week, I am hearing a familiar theme: business is better compared with what it had been during the last several years, but it has not returned to the levels it had been at prior to the economic crisis. The ongoing pressures felt by the pharmaceutical companies, both large and small, are filtering down to the supplier base as well. In a phrase, cautious optimism. Read more »

Congress Moves Again on Drug Safety and Quality

Patricia Van Arnum PharmTech editor As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

Bringing Online Pharmacies Into Line

Peter HoustonLate last month, MEPs on the European Parliament committee responsible for health voted to include sales of pharmaceuticals over the internet in the European Commission’s draft directive on falsified medicines. With some surveys suggesting that more than 60% of drugs purchased online are fake, bringing internet sales under new mandatory safety rules for pharmaceuticals is aimed at reducing the supply of ‘potentially lethal’ fake medicines in the European Union. Read more »

FDA Commissioner Calls for Greater FDA and USP Collaboration

Patricia Van Arnum PharmTech editor Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke at the United States Pharmacopeial (USP) Convention last week and put forth her underlying philosophy as commissoner: building collaborative models to address ongoing challenges to secure public health, which includes oversight of pharmaceutical products. Part of that effort involves building greater cooperation with USP in working on the development and modernization of USP monographs as well as strategies for combating adulteration of products and ensuring product quality. Read more »

Appearing Live at the Javits Center!

Erik Greb PharmTech editorSpring is in the air, and it’s time for a trip to the Javits Center for the annual INTERPHEX conference and exhibition. The editors of Pharmaceutical Technology and BioPharm International have arranged a series of interviews during the conference. We’ll be talking to pharmaceutical professionals, information-technology experts, and regulators about current challenges in manufacturing and about what the future might bring. Read more »

UK suffers medicines shortage

Stephanie Sutton Pharm Tech EuropeParallel trade in the EU: there are arguments for it and arguments against it, but the latest reports from the UK suggest that the trade is having a significantly negative impact on patients and the supply of medicines. Read more »

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 »

Sanctions, Not Barcodes

Corrine Lawrence PharmTech Europe editorTechnology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

Barcodes Fight the Counterfeit Threat

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

Recent Announcements in Anticounterfeiting Technology

Alexis Brekke Pellek PharmTech editorThis week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

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