Market News

Gilead Sciences (GILD)

Gilead Sciences received a major pipeline setback with disappointing results from a phase III trial of darusentan in which it failed to achieve its primary endpoint.
The drug was being studied under an international clinical trial (DAR-312) for the treatment of resistant hypertension. As a result of the setback, Gilead is considering the option of dropping the program so that its resources can be utilized for other potential candidates rather than conducting another intensive phase III study.

Dec 31 · 3:59:00 PM · Source: Zacks
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by Michael Oliveto

Pfizer (PFE)

Pfizer announced that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company`s candidate 13-valent pneumococcal conjugate vaccine.
As a result, the review will continue beyond the prescription drug user fee (PDUFA) action date of December 30, 2009.

Dec 31 · 1:38:00 PM · Source: Reuters
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by Michael Oliveto

Pfizer (PFE)

Pfizer announced the discontinuation of A4021016 (also known as ADVIGO 1016), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer due to the study meeting predefined boundaries for early termination.
An analysis by an independent Data Safety Monitoring Committee (DSMC) showed that the addition of figitumumab to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone.

Dec 31 · 1:36:00 PM · Source: Reuters
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by Michael Oliveto

Johnson & Johnson (JNJ)

Basilea Pharmaceutica Ltd. announces that the US Food and Drug Administration (FDA) issued to the sponsor, Johnson & Johnson Pharmaceutical Research and Development, LLC (Johnson & Johnson PRD), a Complete Response Letter on ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI).
The FDA has indicated in its Complete Response Letter to Johnson & Johnson PRD that it has completed the review of the application and has determined that it cannot approve the application in its present form. The Agency determined that data from Studies BAP00154 and BAP00414 cannot be relied upon because inspections and audits of approximately one-third of the clinical trial sites for these studies found the data from a large proportion of these sites to be unreliable or unverifiable, raising concerns regarding the overall data integrity for both studies.

Dec 31 · 12:16:00 PM · Source: Marketwire
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by Michael Oliveto

Pfizer (PFE)

Pfizer Inc. announced that the Food and Drug Administration (FDA) issued a Complete Response letter regarding the company’s New Drug Application (NDA) for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data contained in the NDA were insufficient to support approval.
“We are disappointed with the FDA’s decision and will work with the agency to determine next steps,” said Steve Romano, vice president, Medical Affairs Head, Primary Care Business Unit. “Given the chronic nature of GAD and the number of patients who continue to experience anxiety symptoms despite treatment, there is a clear unmet need for new and different treatment options.”

Dec 29 · 2:41:00 PM · Source: Pharmabiz
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by Michael Oliveto

Merck (MRK)

Merck recently informed its partner Arena Pharmaceuticals that it was pulling out of a collaboration agreement pertaining to the development of an atherosclerosis drug.
The decision by Merck to discontinue the development of the candidate, MK-1903, a niacin receptor agonist for treating atherosclerosis, followed disappointing results from a recently completed mid-stage study.

Dec 29 · 2:31:00 PM · Source: Benzinga · Related: Arena Pharmaceuticals Inc.
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by Michael Oliveto

Johnson & Johnson (JNJ)

Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.
Johnson & Johnson had recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea. The health care company said the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

Dec 29 · 1:59:00 PM · Source: MSN Money
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by Michael Oliveto