Pharma Under Pressure to Restrict Execution Drugs
Source The ongoing scramble by some states for lethal injection drugs has prompted a new campaign by activists to pressure drugmakers not to make their medications available. The undertaking is called the Pharmaceutical Hippocratic Oath, which drugmakers are being asked to sign and pledge that their medicines will be used to ‘help, not harm.’ So […]
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White House supports PDUFA bill
The White House issued a statement of support for an FDA reauthorization bill on Thursday. “The administration strongly supports passage of S. 3187, the Food and Drug Administration Safety and Innovation Act, which will help speed safe and effective drugs, medical devices and bio-similar biological products to patients,” a statement from the Office of Management […]
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Botox maker Allergan announces R&D expansion in Bridgewater
Allergan, which makes Botox, will build a nearly $12 million research and development facility in Bridgewater, the company and the site’s owner, SJP Properties, announced yesterday. Based in California, Allergan first said it was considering expanding in New Jersey in November, when it was awarded a $14.9 million grant from the New Jersey Economic Development […]
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FDA All Over Accordia in Warning Letter for Late AE Reports
Source Three strikes and you’re out? In 2006, the FDA noticed that Acorda Therapeutics was having difficulty submitting serious and unexpected adverse event reports within 15 days of receiving such information as required by law. The same problem was observed during yet another inspection three years later. And when the FDA returned last summer, the […]
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Bristol-Myers says FDA clears Mass. plant
Bristol-Myers Squibb Co. said Tuesday the Food and Drug Administration approved a new manufacturing plant where the company will produce its rheumatoid arthritis drug Orencia. The plant is in Devens, Mass. Bristol-Myers said about 300 scientists, engineers, quality specialists and other employees work there. It said the new plant will help the company meet demand […]
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Federal Agency Needed to Oversee DSM?
Source Last week, the American Psychiatric Association unexpectedly backed down from two controversial proposals that would have increased the number of people who could have been diagnosed with psychotic or depressive disorders. The change meant that attenuated psychosis syndrome and mixed anxiety depressive disorder will not be listed in the fifth edition of the Diagnostic […]
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Bristol Myers Squibb Exec Ordered to Write Book For Punishment
Source Three years ago, a former Bristol-Myers Squibb senior vice president named Andrew Bodnar pleaded guilty to lying to federal authorities about a botched patent deal involving the Plavix blood thinner, an episode that contributed to an overhaul of its c-suite. As for Bodnar, a judge did something highly unusual that quickly became a wry […]
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FDA Drug Reviews Occur Quickly, Study Shows
Source A key point in the debate over renewing the Prescription Drug Fee User Act, or PDUFA, has been the ability of the FDA to review drugs as quickly as possible. Along with the pharmaceutical industry, various members of Congress complain the agency moves too slowly. But a new study in The New England Journal […]
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Abbott Finally Escapes Consent Decree
Source After more than a dozen years, Abbott Laboratories is no longer operating under a consent decree. The settlement was made in 1999 after a remarkable six-year run of manufacturing deficiencies and subsequent failures to fix various problems in its diagnostics division. The decree was terminated last month, according to an Abbott spokeswoman. The move […]
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FDA Panel Okays Arena Diet Pill
Source In a move that may herald a new era in fighting fat, an FDA advisory panel this afternoon voted 18-to-4 to recommend the agency approve the Arena Pharmaceutical diet pill, which is known as Lorqess. This marks the second time in three months that an FDA panel has decided the benefits of reducing the […]
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