Peregrine Pharmaceuticals has reported that its lead product candidate bavituximab achieved the pre-specified stage 1 primary endpoint in its ongoing Phase II clinical trial in patients with metastatic breast cancer.[...]
Boston Scientific Corp. announced Wednesday that the U.S. Food and Drug Administration has approved the company's Promus drug-coated coronary stent.[...]
Catalyst Pharmaceutical Partners said it has begun enrollment for its U.S. Phase II clinical trial of a treatment for patients addicted to methamphetamine. (CPRX)[...]
CNBC |
July 3rd, 2008 |
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Drug developers Wyeth and Progenics Pharmaceuticals Inc. said Thursday European regulators approved Relistor as a treatment for constipation related to pain drugs taken by terminally ill patients. Read More Permalink[...]
Harvard University professor Daniel Carpenter has come out with a revised version of a study concluding that drugs moving too quickly through the FDA approval process are more likely to be linked to safety problems later. Though admitting to data mistakes in his original study, he stands behind his original [...]
pharmalot |
July 3rd, 2008 |
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Not surprisingly, the editors of The New England Journal of Medicine say 'yes.' Preemption, you may recall, is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agencys actions are the final word on [...]
CNBC |
July 3rd, 2008 |
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Abbott Laboratories will reach its market share goals for its drug-coated Xience V stent, analysts said Thursday. Read More Permalink[...]
pharmalot |
July 3rd, 2008 |
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The agreement between the Office of New Drugs and the Office of Surveillance & Epidemiology spells out which unit will take the lead on specific safety issues. And for drugmakers, this is going to be a big change, because the OSE, which was never viewed by pharma as an ally [...]
pharmalot |
July 3rd, 2008 |
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A Harvard University professor defended research suggesting the FDA was too hasty in approving drug, which the agency has criticized as mistaken, The Wall Street Journal writes. The professor, Daniel Carpenter, acknowledged that the FDA had identified mistakes in his study, which was published by the New England Journal of [...]
Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach! FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding [...]
An FDA panel of outside medical experts said the agency should raise standards for approving diabetes drugs, a move that could affect the $5 billion-plus diabetes drug market in the U.S.[...]
Wyeth announced that Bernard Poussot, 56, its president and CEO, has assumed the additional position of chairman of the board. Boehringer Ingelheim GmbH said its chief executive officer, Alessandro Banchi, will retire from his post at the end of the year and Andreas Barner, currently deputy CEO, will replace him. [...]
pharmalot |
July 2nd, 2008 |
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The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will conclude today a two-day meeting to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large And one non-voting panel member, [...]
Symbio LLC has opened a new Phase I clinical unit in Michigan City, IN. Symbio provides clinical trial management, biometrics, consulting, product development and topical formulation development. With the addition of the Phase I Unit, the company can provide Phase I through Phase IV development. The Phase I unit has [...]
Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is [...]
pharmalot |
July 1st, 2008 |
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Earlier this year, Amgen went out of its way to disavow a widely publicized case study that suggested Enbrel, which is only approved for treating rheumatoid arthritis and psoriasis, may be useful in combatting Alzheimers disease. In fact, the biotech issued successive press releases due to the single-patient case study, [...]
CA-San Francisco, Our client is the industry's only company exclusively focused on driving clinical trial performance at the site level, offering assistance and advocacy to research centers - directly and through their[...]
Clinical trials 2 positions available - SAS programmer + clinical trial experience + SAS certified in Santa Clara, CA SAS programmer + Clinical trial experience... (From Dice)[...]
This position is responsible for overall clinical study management. A team player that has the ability to work well with many different functions to support the overall program[...]
JOB SUMMARY: The Clinical Trial Coordinator's role is to support clinical trial start up, maintenance and close out activities, as well as provide coordination of other[...]
