Drug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Another very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.

If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011. Read more »

This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »

Industry executives revealed their biggest worries for global supply-chain management in a report by PricewaterhouseCoopers and the analyst firm Axendia that focused on major areas of concern in the pharmaceutical supply chain. The report, titled Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity, surveyed 112 executives from the pharmaceutical, medical device, and biotechnology sectors. Read more »

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 »

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 »

Late 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 »

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 »

Spring 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 »

Parallel 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 »