China May Blacklist Bad Capsule Makers
Source In the wake of a controversy over unsafe capsules in China, the State Food and Drug Administration may blacklist some pharmaceutical manufacturers. The move is seen as an effort to restore a degree of public confidence after the SFDA conducted a month-long probe and found that 254 pharmaceutical companies, or 12.7 percent of all […]
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FDA May Ban Lice Shampoo for Children
source In a move that casts a spotlight on a little-known controversy, a Massachusetts congressman has asked the FDA to halt the use of an insecticide in pharmaceutical treatments for head lice in children. Known commercially as Lindane, the chemical has been widely used as an agricultural tool around the world, but is also a […]
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CRO Employee Convicted for Stealing Merck Compounds
Source Last month, a court in Shanghai convicted a former employee of WuXi PharmaTech, a contract research organization with operations in the US and China, of stealing samples of two different Merck compounds that were being tested in Chinese facilities. Xiao Hao was given an 18-month sentence, including six months that were suspended, and ordered […]
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Pharma giant Pfizer to shed 180 jobs
Pfizer is to let 180 workers go at its two Cork plants in Little Island and Ringaskiddy, with staff to be briefed on the job losses later this week. The Irish Examiner understands that between 120 and 130 jobs will go at the Ringaskiddy plant and the remainder at Little Island, where the cholesterol reduction […]
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J&J Stops Selling Vaginal Mesh Implants
Source In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina. […]
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Bad Week for Vertex Pharma
Source This is not a good week for the executive team at Vertex Pharmaceuticals. Two days ago, the drugmaker revised previously announced interim results of a Phase II study of a combination cystic fibrosis treatment, taking the wind out of its once hot stock and tarnishing its credibility (see here). Now, the FDA has issued […]
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Franck’s Pharmacy Issues Extensive, ‘Urgent’ Recall After Facility Contamination
Pharmaceutical compounder Franck’s Pharmacy issued what it called an “urgent†recall of all of its sterile human and veterinary products after an inspection by the US Food and Drug Administration (FDA) found fungal growth and microorganisms in a supposedly sterile room. “In light of the FDA’s findings and the resulting possible risk of infection, we […]
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Ranbaxy hires consultants as part of consent decree with USFDA
Drug major Ranbaxy Laboratories today said it has hired two US-based consultants to advise it on remedial work to be done at its manufacturing units in India as part of a consent decree signed with the USFDA to revoke ban imposed by the US health regulator. The company said it expects the consultation process to […]
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Analysis: Drugmakers vulnerable if health law revoked
Pharmaceutical companies, which were spared some of the more sweeping regulations in President Barack Obama’s healthcare overhaul, could come under more pressure if the U.S. Supreme Court strikes down part or all of the 2010 law. Drugmakers agreed to pay about $100 billion over 10 years in excise taxes and discounts on medications under the […]
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New Antibiotics Needed for Tough Bugs?
Source Yesterday, several European drugmakers – including GlaxoSmithKline and Sanofi – agreed to work with academics to combat antimicrobial resistance and speed the delivery of new antibiotics. The $285 million effort, called NewDrugs4BadBugs, will be run by the Innovative Medicines Initiative, which was launched by the European Commission. The move reflects not only a growing […]
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