Archive for the 'Outsourcing' Category

Rx-360 Goals Get off the Ground

Angie Drakulich PharmTech editorMany 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 »

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 »

Cautious Optimism Prevails at CPhI in Madrid

Patricia Van Arnum PharmTech editor 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 »

Is Industry Ready to Share Supplier Audits? Rx-360 Takes a Shot.

Angie Drakulich PharmTech editorThe 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 »

Trials without Tribulations

Erik Greb PharmTech editorPfizer (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 »

Contract Manufacturers: Watch Out for a Bumpy Ride

Patricia Van Arnum PharmTech editor The mood at the 2009 installment of InformEX, the exhibition of custom and batch manufacturers, which was held in San Francisco last week, had a decidedly subdued tone. The culprit: the uncertainty of the economy and its implications on spending and financing, particularly for small- to medium-sized pharmaceutical companies. Read more »

Once Bitten, FDA Becomes More Vigilant

Erik Greb PharmTech editorThe US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. Read more »

A Policy Wish List for Contract Manufacturers

Patricia Van Arnum PharmTech editor As Congress begins a new session, the Synthetic Organic Chemical Manufacturers Association (SOCMA) is making its legislative priorities known. SOCMA is the US-based trade association of batch and custom manufacturers, which includes contract manufacturers of pharmaceutical intermediates and active pharmaceutical ingredients (APIs). Through its “First 100 Days” initiative, SOCMA says it plans to meet with new agency heads and key Congressional members to share the priorities of the specialty and batch manufacturing industry and to seek bipartisanship wherever possible. Read more »

AAPS 2008 Coverage :: Videos from the Show Floor

At this year’s AAPS Annual Meeting and Exposition, Pharmaceutical Technology editors conducted video interviews with industry leaders recorded live at PharmTech’s booth on the exhibit floor. Click on the titles below to watch the vidcasts.

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