At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »
Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. 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 »
It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.
Italians are known for their passions. They are passionate about their food, their wine, their art, their design, and in Bologna, they are passionate about their packaging industry. And well they should be. In a time of economic crisis, Italy’s packing industry seems extremely healthy, based on the statistics offered last week by Dr. Guido Corbella, at the Pharmintech exhibition.
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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 »
Pharmaceutical 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 »
I have just returned from an event in France which, I have to say, really impressed me. Not because I had the perfect excuse to visit Paris for a couple of days (although that was undoubtedly a bonus), but because I was so impressed by the calibre of presentations and new innovations that were showcased from this relatively small meeting. Read more »
Hands up those of you who read the labels on your medication bottles ‘every’ time you’re due to administer a dose? Not many of you I bet. While much publicity highlights the dangers of counterfeit drugs (and rightly so), what about the dangers linked to incorrectly taking genuine medication? Read more »
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 »
From PharmTech.com