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 »
The confetti from the New Year’s celebrations has settled, and drugmakers are busy planning their activities for 2011. Some people make New Year’s resolutions in hopes of bettering themselves or adopting good habits. After its recent disappointments, the pharmaceutical industry likely will resolve to improve its research and development (R&D) efforts. Read more »
Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »
Ever want to know exactly what your contract service providers are doing on a day-to-day basis in the lab? Ever wonder how your product is moving along in its manufacturing process? A new video monitoring service from Metrics, called “PharmaVision,” can now give you these opportunities. Read more »
In January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? 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 »
The recession has been particularly tough for pharmaceutical-industry employees. During the first five months of 2009, 51,034 of them lost their jobs. Only the government and retail sectors laid off more workers during that period. Given these somber figures, many in the industry probably hoped for a positive omen in the US Bureau of Labor Statistics’s monthly jobs report, which was released on Friday.
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 »
From PharmTech.com