Nutley’s Roche demolishes La Monte buildings
A symbol of Nutley’s industry has come down. The buildings were owned by Roche, part of its Nutley-Clifton campus, which decided they were no longer necessary. “As a research and early development site, we are continuing to assess our facilities and have determined that several buildings are no longer needed, based on the scope of […]
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State Council approves plan to vouchsafe drug safety
The State Council approved a blueprint on Wednesday to establish a credit rating system and intensify monitoring of pharmaceutical groups to boost the country’s drug safety over the next five years. “Our country’s pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. […]
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Alexza Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review Finds
Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale. While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in […]
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Was HHS Correct To Overrule The FDA On Plan B?
In an unprecedented move, the US Human & Health Secretary Kathleen Sebelius yesterday overruled the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The contraceptive is available only to women age 17 and older without a prescription, but behind counters. The […]
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And the Winner for Worst Biotech CEO Is….
If you guessed that Mitch Gold, who heads Dendreon, you would be right. He won this sad distinction in the annual reader poll conducted by The Street, where he nabbed 37 percent of the 1,800 votes for stunning investors – and just about everybody else – by scrapping his sales forecast for the year after […]
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The FDA Targets Novartis Manufacturing Plants
If you happen to run a big drugmaker, you know the FDA has its eye on you when a warning letter cites a host of problems at three manufacturing facilities and you are instructed to schedule a meeting within five days to discuss plans to rectify your myriad transgressions. In other words, the heat is […]
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AstraZeneca Is Cutting 1,150 Sales Jobs
Just weeks after disclosing plans to eliminate 400 jobs in its commercial business and US headquarters, AstraZeneca told employees this morning that anotehr 1,150 jobs will be choppedfrom the US sales force. The move will shrink the US sales force by 24 percent, according to a statement released by the drugmaker. In describing the move, […]
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White House Overrules FDA On Access For Plan B
In a move fraught with presidential politics, the US Department of Health & Human Services has overruled the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The contraceptive is currently available only to women age 17 and older without a prescription, […]
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Stop The Bleeding: FDA Probes Pradaxa Deaths
Less than a month after European regulators asked doctors to exercise caution about using the Pradaxa bloodthinner, the FDA has decided to investigate post-marketing reports of serious bleeding patients. As of November 6, the European Medicines Agency was aware of 256 cases of serious bleeding that results in patient deaths associated with the Boeheringer Ingelheim […]
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Despite Mandates, Few Study Results Are Reported
Four years ago, the US began requiring researchers to register studies of prescription drugs and report results on ClinicalTrials.gov, the federal database. But a new study found that, while the mandate increased the number of trials that were registered, 39 percent were actually registered late and results for only 12 percent of completed trials were […]
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