Brokers Jailed For Hiring Women For Clinical Trials
Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who are mostly farm workers and daily wagers, have developed acute joint pains, […]
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USA approves new cancer drugs faster than EMA: study
During 2003-10, the US Food and Drug Administration (FDA) approved more new cancer drugs, and did it faster, than the European Medicines Agency (EMA), and the drugs approved by both agencies got to US patients more quickly than to Europeans, says a new study. The FDA approved 32 new anti-cancer drugs during 2003-10 compared to […]
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J&J jolts the cardio crowd
Johnson & Johnson is giving up on heart stents. Hundreds of thousands of patients around the world carry these amazing implants but apparently not enough. The company’s name is synonymous with the development of heart stents and the huge market it created. New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines in […]
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FDA warns Philips of non-compliance with CT, nuke med manufacturing requirements
The FDA sent Philips Healthcare of North Andover, Mass, a warning letter on June 7, noting that its manufacturing methods at its Cleveland facilities do not conform with required current good manufacturing processes. June 21 – Webinar – Former FDA Chief Council Sheldon Bradshaw – Latest Warning Letter Trends for 2011 Save $100.00 Per Site […]
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Pfizer, BI Inhaler May Raise Risk Of Early Death
The blockbuster inhaled lung medication Spiriva, which is sold by Pfizer and Boehringer Ingelheim, may raise the risk of an early death, according to a new review of clinical studies. When administered in mist form, the drug was associated with a 52 percent increase in mortality risk, compared with patients given a placebo, according to […]
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Dr. Reddy’s Tarnished by FDA warning, fire probe
Dr. Reddy’s is facing regulatory troubles on two continents. The branded generics maker has received an FDA warning letter concerning an intermediates and API manufacturing plant in Mexico. And it’s being probed by India’s directorate of factories over alleged safety violations that contributed to the deaths of two workers at facilities in Andhra Pradesh, east […]
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FDA Warns Dr. Reddy Over Bad Ingredients In US
Yet another instance in which the supply chain causes concern. This time around, Dr. Reddy’s Laboratories, one of the largest drugmakers in India, was tagged by the FDA for failing to properly validate methods for testing active pharmaceutical ingredients at a plant in Mexico. And this is a problem because adulterated ingredients are now circulating […]
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Why A Boehringer Unit Really Has Drug Shortages
For the past several months, physicians and hospitals have bemoaned a growing shortage of various drugs, notably to treat cancer. The problem, which has prompted legislation in the US Senate, has contributed, in some cases, to rising prices and increased prescribing errors . New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines […]
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Embattled wipe-maker responds to federal injunction
The Wisconsin firms accused of making and distributing alcohol wipes and other medical products potentially tainted with life-threatening bacteria say they view the permanent injunction filed against them as a step toward resuming operations. “This is the all-important first step in resuming our manufacturing operations,” said Eric Haertle, president of H&P Industries, in a press […]
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Federal action bars Wisconsin company from making or distributing health care products
Federal regulators have taken legal action to bar a Wisconsin company from making or distributing its health care products, following five recalls of disinfectant wipes and other health care products. The Food and Drug Administration said Monday that federal prosecutors filed a legal injunction against the Triad Group and H&P Industries of Hartland, Wisconsin. Once […]
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