Its acne drug Velac seemed a sure thing for federal approval following positive Phase III data.
In Phase III, lingering into 2008, mortgage lenders will relearn the fine art of saying no.
Biologics now account for half the products currently in Phase II and Phase III clinical trials.
This study is actually the first of four placebo-controlled, Phase III trials to be completed.
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Currently, Celgene is enrolling patients for a phase III trial in MDS, List says.
Merck obviously needs the data to get to Phase III, but a payout is far from clear.
The Phase III trial will compare TroVax plus standard kidney cancer treatment and a dummy version plus standard treatment.
Of the eight deals Roche has done this year, only one involves a drug that has reached phase III.
The most common adverse reactions in the Phase III trial were gastrointestinal, reported by 27 (93%) of 29 patients.
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"It is the sad fact of this industry that the first phase III trial is rarely perfectly designed, " said Crooke.
He realized gains a bit early, after last May's phase III success of Avastin, which is now on the market.
Depomed also has a phase III product that is aiming to become the first FDA approved product for hot flashes.
Unfortunately, it would appear that the restructured schedule, with its two and half year slip in reaching Phase III, will preclude such consideration.
Those various elements of cultural heritage are at the heart of the inventory work undertaken as part of Phase III of the project.
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While Phase III ended on January 7th, we have launched a two-week bonus period for all of you who signed off for the holidays.
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Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects.
Last year, Enzon Pharmaceuticals terminated its co-development agreement with Inex after the FDA issued a "non-approvable" letter for Marqibo, saying Phase III trials were necessary.
Today it is unveiling more data from that Phase III study, showing exactly how much Lucentis improved vision in AMD patients versus a placebo injection.
"Phase III trial results for secondary indications of marketed drugs that fail to achieve approval will also be posted, " Lilly stated in its press release.
Thus, one must still view the Phase III as highly speculative.
It is also approved to treat rheumatoid arthritis and, is being studied in a Phase III trial in a different set of patients who have lupus nephritis.
Amylin Pharmaceuticals (nasdaq: AMLN - news - people ) is in phase III trials of Exenatide, a drug that promises to treat Type 2 diabetes.
The Phase III segment would then begin with 1, 700 patients, and there is speculation that second Phase III trial might also be attempted with only earlier-stage patients.
Recall that a few patients in the phase III study presented last fall at ACR also experienced heart failure, but that TNFs are also associated with heart failure.
On its recent Q4 conference call with analysts Pfizer confirmed the likely progression of its own Herceptin biosimilar program into Phase III clinical trials later this year.
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The vaccine, called AIDSVAX, is currently undergoing Phase III trials.
From Phase II studies as well as the Phase III Oral Solo trial (presented at the ACR last November), the agent has proven to be clinically potent and rapidly effective.
These positive results help pave the way for the pivotal Phase III efficacy study that will recruit up to 16, 000 children and infants at 11 trial sites in seven countries.
With successful conclusion of this Phase III clinical program, LibiGel could be the first product approved by the FDA for women with low sexual desire, HSDD, a significant unmet medical need.
In addition, the experimental insomnia drug Suvorexant exhibited strong efficacy in phase III clinical trials as the drug helped insomnia patients fall asleep faster and stay asleep longer versus a placebo.
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