Amgen Must Let Feds Interview Its Employees
For the past five years, the US Attorney in Brooklyn, New York, has been investigating Amgen for allegedly violating the False Claims Act. At issue are a host of allegations, most notably that Amgen violated HIPAA and offered kickbacks to doctors in order to boost sales of its various meds and steal market share from […]
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FDA Says It Needs New Approach on Imports
Border and port inspections alone aren’t sufficient to make sure the imported food and drugs consumed by U.S. residents are safe. That’s the word from the FDA, which today laid out a plan to monitor the rising tide of goods from abroad. It includes planned partnerships with counterpart regulators in other countries and better data-sharing […]
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Bayer Off-Label Promotion Of Yasmin Birth Control Pill For Acne Caused Teenager’s Death: Lawsuit
The thousands of lawsuits filed against Bayer over alleged injuries and deaths relating to the Yaz and Yasmin contraceptives typically dwell on higher risks beyond those of traditional birth control pills and overly aggressively promotion that failed to disclose the possibility of blood clots, in particular. Now, though, a lawsuit charges off-label promotion for acne […]
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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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