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.

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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 »

Sourcing, procurement, and supply-chain professionals from the pharmaceutical industry and their suppliers are gathering this week in New York City at DCAT Week, an annual event of educational programs and business-networking opportunities organized by the Drug, Chemical and Associated Technologies Association. (DCAT). The first day of the event kicked off on Monday with an educational program addressing the impact of changing market fundamentals on innovator-drug and generic-drug companies. Read more »

Many 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 »

These days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. Read more »

Last week we saw more signs that pharmaceutical megamegers bode ill for New Jersey workers. Business Week reported that Pfizer (New York) planned to close six research and development (R&D) facilities—some of its own, and some of Wyeth’s (Madison, NJ). Many of the 400 employees at Wyeth’s research offices in Monmouth Junction, New Jersey, could be laid off. And last Wednesday, Richard Clark, CEO of Merck (Whitehouse Station, NJ), told attendees at a Goldman Sachs conference that research jobs at Schering-Plough’s (Kenilworth, NJ) headquarters could be eliminated to reduce costs. Read more »

What is the outlook for contract manufacturing of active pharmaceutical ingredients and intermediates? In gaining feedback from exhibitors and attendees at CPhI Worldwide, the large exhibition and conference of pharmaceutical ingredients, which was held in Madrid last week, the prevailing sentiment was one of cautious optimism. Most said business conditions have improved since the financial crisis began in September 2008, but that the level of outsourcing has not returned to levels reached before the start of the economic downturn. Read more »

The buzz around Rx-360, an international pharmaceutical supply chain consortium headed by seven advisory panel members including Martin Van Trieste of Amgen, has been brewing for months. More than 125 people attended the consortium’s launch meeting in Washington, DC, last Friday, June 5—quite a few more than Van Trieste and his team originally expected. Clearly, the turnout demonstrated industry’s interest in working together to help improve supply chain security. Also demonstrating a yearning for cohesion were the results of the meeting’s live polling questions. Using devices to vote from their seats, 100% of meeting participants agreed that Rx-360 was needed. Most also said they would join or are considering joining the consortium. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »