Covance to close Arizona tox site as weak demand continues
Covance is to close its toxicology facility in Arizona after early development demand dipped at the start of 2012. May 17 – How to Survive PREDICT
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Abbott Shells Out $1.6 Billion to Settle Depakote Issue
Source In the second-largest such settlement by a drugmaker, Abbott Laboratories has agreed to pay $1.6 billion to resolve various probes into the marketing of its Depakote seizure med. The drug and device maker also pleaded guilty to one misdemeanor violation for misbranding, and entered into a five-year Corporate Integrity Agreement, which will be transferred […]
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Sanofi Chemist Imprisoned for Stealing Proprietary Chemical Compound Data
Source Four months after pleading guilty to stealing trade secrets from Sanofi and selling compounds through another company in which she held an interest, Yuan Li was sentenced yesterday to 18 months in prison, according to court documents. The former chemist must also pay $131,000 in restitution and will contend with two years of supervision […]
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Serious Problems At Novartis Plant in Austria, Too
Source Over the past few months, Novartis has struggled with a string of problems at several manufacturing plants. Notably, a facility in Nebraska suffered embarrassing gaffes involving over-the-counter meds and animal health drugs (see this and this). And the FDA sent a warning letter last November for “significant violations†at two other US plants – […]
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Federal Agents Arrest Thieves Who Stole Drugs from Lilly Warehouse
Source Nearly a dozen people have been arrested in connection with the daring heist of more than $70 million in prescription drugs from an Eli Lilly warehouse in Connecticut two years ago, as well as other pharmaceutical thefts in New Jersey and Virginia, according to the US Attorney in New Haven. The ringleaders, who are […]
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New Bill Would Mandate Clinical Trial Disclosures
Source In response to the ongoing controversy over the lack of disclosure of clinical trial data, a Republican Congressman has introduced a bill that would require study results to be reported to ClinicalTrials.gov – the federal repository – regardless of whether the outcome is positive or negative. But there is more. The bill would also […]
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House Starts Probe Of Pharma Deals on Obamacare
Source large drugmakers are being probed by Congress as part of the deal reached between the pharmaceutical industry and the Obama administration to support the Democratic Party overhaul of the US health care system. The investigation by House Republicans began last year and was expanded to include several drugmakers when an unnamed industry trade group […]
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Bayer Makes Challenge on Mandatory License in India
Source In a move that was largely expected, Bayer late last week challenged a compulsory license awarded two months ago by India’s Patent Office to a generic drugmaker to make a copy of the Nexavar kidney and liver cancer med. The landmark decision, which covers only domestic distribution, was made on the grounds that the […]
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DMAA Class Action Suits Follow FDA Warnings
Following FDA warning letters sent to various marketers of DMAA (dimethylamylamine) products, which detailed numerous ways the agency considered the products illegally marketed, plaintiffs have filed class action lawsuits against several of the companies that received the FDA letters. In one such suit, plaintiff Anthony Velasco alleged he bought MethylHex 4,2 and relied the efficacy […]
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Impax Labs falls on weak sales, new FDA warning
Shares of Impax Laboratories Inc. dropped Tuesday after the generic drugmaker reported disappointing first-quarter revenue and said regulators found ongoing deficiencies at one of its plants. Impax said its profit shrank 11 percent in the first quarter, to $12.4 million, or 18 cents per share, from $13.9 million, or 21 cents per share. The company […]
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