Fire injures nine in Teva’s Croatian factory
A fire at Teva’s factory in Croatia has injured nine people including one in critical condition, local media reports. The fire was at the Zagreb factory of Pliva Pharmaceuticals, owned by Teva, and which produces generic drugs. Indications are that the fire was caused by an electricity short circuit. Teva said that production at the […]
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Bristol-Myers Hit Again For Deaths of Monkeys
Source: Pharmalot For the second time in less than a year, Bristol-Myers Squibb has been cited by the US Department of Agriculture for violating the Animal Welfare Act by allowing a monkey to die at one of its facilities. Although the exact cause of death was not disclosed, the macaque was left unattended last December […]
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FDA clampdown driving Indian compliance investment; ICRA
Indian drugmakers will increase investment in GMP compliance to avoid becoming the next company hit by the FDA, a credit rating agency said.
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Dr Reddy’s: FDA to inspect Mexico plant in March
Dr. Reddy’s Laboratories Ltd. said it has been informed of an inspection by the U.S. Food and Drug Administration of its Mexico facility during the last week of this month. The drug regulator had in June last year banned imports into the U.S. of some active pharmaceutical ingredients and steroids made at Dr. Reddy’s Mexico […]
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GSK, Merck meet with FDA advisory committee Tuesday
Tuesday is a big day – and a challenging one – for cancer crews at GlaxoSmithKline and Merck because both companies are scheduled to speak with the U.S. Food and Drug Administration’s oncologic drug advisory committee at FDA headquarters in Silver Spring, Md. The meeting starts at 8 a.m., and information about the web cast […]
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Pharma Employee Job Stress on Rise
Source: Pharmalot With the overwhelming and ongoing number of job losses across the pharmaceutical industry, few would be surprised that many employees are anxious about the future. Each drugmaker has slashed research projects and marketing budgets, sending scientists and sales reps overboard at eye-popping rates. Also high on the list: the people who get the […]
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Novartis To Benefit from Its Own Drug Shortage?
Source: Pharmalot Last month, Novartis slowed or discontinued production of various medicines at a plant in Boucherville, Quebec, where most of Canada’s generic injectables are made, after recent FDA inspections found various manufacturing problems (back story). And the move by the Sandoz facility has since created a shortage that has alarmed physicians and regulators alike. […]
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Teva Slapped by FDA for Copaxone Promo
Source: Pharmalot Nothing like a little exaggeration to quickly attract the wrath of the FDA. And this is what Teva Pharmaceuticals did with both a panel display at the recent American Academy of Neurology about its Copaxone multiple sclerosis treatment and a ‘Team Copaxone’ web site that the drugmaker designed to promote the medication. In […]
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FDA 483 details 400 complaints that led to APP warning letter
The FDA has published a 483 detailing some of the 400 customer complaints that led to it sending a warning letter to APP Pharmaceuticals.
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Apotex Sues FDA Over Import Alert That ‘Decimated’ Its Business
Source: Pharmalot Three years ago, the FDA issued an import alert for all meds made at a pair of Canadian facilities run by Apotex, which was one of the biggest generic suppliers to the US market, which subsequently recalled 675 batches of different drugs. The move came after the FDA sent warning letters to the […]
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