Informex 2011: Tracking the Fortunes of Chemically Synthesized APIs

Patricia Van Arnum PharmTech editor I am here in Charlotte, North Carolina, this week for Informex 2011, the trade show of custom and batch manufacturers, which raises a fundamental question. What is the future for outsourcing of chemically synthesized active pharmaceutical ingredients (APIs) and pharma intermediates? Read more »

The Executioner’s Drug

Erik Greb PharmTech editorAt 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 »

Will 2011 Be the Year of Innovation?

Erik Greb PharmTech editorThe 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 »

Memo to Congress: Hands off FDA

Erik Greb PharmTech editorIn 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 »

Rodney Dangerfield and R&D

Erik Greb PharmTech editorThese 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 »

Pink Slips and Pipelines

Erik Greb PharmTech editorLast 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 »

Inside the Minds of Procurement and Sourcing

Patricia Van Arnum PharmTech editor Strategies to improve sourcing and procurement, including risk mitigation, was a key theme addressed at a recent conference for supply-chain professionals in the pharmaceutical industry. The conference, the Strategic Sourcing Summit, was held this week in New Brunswick, New Jersey, and was organized by the Drug, Chemical, and Associated Technologies Association’s (DCAT) Supply Management Committee and the Pharmaceutical Forum and the Chemical Group of the Institute for Supply Management. The conference featured perspectives from economists, analysts, regulatory officials, and chief procurement officers. Read more »

Will We See Country-of-Origin Labeling for Pharma Ingredients?

Patricia Van Arnum PharmTech editorA requirement for country-of-origin labeling for pharmaceutical ingredients was placed once again on the Congressional agenda, with the introduction of a Senate bill (S. 3633), the Transparency in Drug Labeling Act, which was introduced by Sen. Sherrod Brown (D-OH) in late September. The bill is another effort by Congress this year to mandate country-of-origin labeling for pharmaceutical ingredients, which is increasing the likelihood that the pharmaceutical industry may see such a requirement in the future. Read more »

Big Pharma’s Outsourcing Between a Rock and a Hard Place

Patricia Van Arnum PharmTech editorA second information request by Sen. Sherrod Brown (D-OH) of the Senate Committee on Health, Education, Labor and Pensions (HELP) on the outsourcing practices of a major pharmaceutical company—this time Merck & Co.—is moving the issue of outsourcing into an uncomfortable zone of political expediency versus constructive debate. Read more »

East Meets West in Contract Research

Patricia Van Arnum PharmTech editorCovance’s (Princeton, NJ) announcement this week that it will partner with Shanghai’s WuxiPharmaTech in a joint venture for preclinical services reflects a shifting paradigm in pharmaceutical outsourcing. Read more »

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