Shares of Cumberland Pharmaceuticals (CPIX) are having a rough go of it after the Food and Drug Administration (FDA) outlined some concerns that will further delay a ruling on its liver drug. The regulatory agency already postponed its decision from August to December, and now the FDA says it needs additional data before it can recommend the drug for approval.

In its complete response letter to Cumberland, the FDA noted insufficient evidence to prove that the injectable drug, Acetadote, is effective in all patients. Cumberland said it plans to meet with the FDA soon to address the outstanding issues.

Continue reading Cumberland Pharma Plummets After FDA Rejection

Cumberland Pharma Plummets After FDA Rejection originally appeared on BloggingStocks on Wed, 22 Dec 2010 13:00:00 EST. Please see our terms for use of feeds.

Mela Sciences (MELA) gapped higher right out of the gate Monday, with the shares surging roughly 12% on Monday morning. Over the weekend, Barron's noted that the stock is "worth a close look ahead of a regulatory vote on Nov. 18," and traders are apparently taking the suggestion to heart.

The financial publication described its opinion on the shares as "cautiously optimistic," explaining that analysts believe MELA could double if its MelaFind device receives the OK from a Food and Drug Administration (FDA) panel this Thursday. However, warned Barron's, a regulatory thumbs-down "could cut the shares in half."

Continue reading Mela Sciences Surges Ahead of FDA Panel

Mela Sciences Surges Ahead of FDA Panel originally appeared on BloggingStocks on Mon, 15 Nov 2010 11:30:00 EST. Please see our terms for use of feeds.

Arena Pharmaceuticals (ARNA) is taking a serious beating, with the stock down about 40% at last look. Traders are reacting to new concerns raised by the Food and Drug Administration (FDA) over Arena's experimental obesity drug, lorcaserin. Following an initial review, FDA staff cited "three noteworthy safety issues" with lorcaserin: heart valve disease, psychiatric and memory problems, and excessive tumors in rats.

The drug met one of the FDA's effectiveness standards "by a slim margin," with 47% of study participants shedding 5% or more of their body weight -- but lorcaserin fell short on another measure of effectiveness. Patients treated with lorcaserin in a study experienced just 3% greater weight loss than patients treated with a placebo, falling short of the FDA's 5% benchmark.

Continue reading Arena Pharmaceuticals Hammered by FDA Concerns

Arena Pharmaceuticals Hammered by FDA Concerns originally appeared on BloggingStocks on Tue, 14 Sep 2010 12:30:00 EST. Please see our terms for use of feeds.

Continue reading ADHD Patch Helps Investors Focus on Shire

ADHD Patch Helps Investors Focus on Shire originally appeared on BloggingStocks on Wed, 07 Jul 2010 18:00:00 EST. Please see our terms for use of feeds.

AstraZeneca (AZN) is in a race against time to develop new drugs as patent expiration dates are looming for some of its most profitable medicines over the next few years.

The company had hoped that motavizumab -- a medicine that is supposed to help prevent respiratory disease in infants -- would be one of the drugs to issue in a new era of profits by replacing Synagis -- a patented drug that fights the same virus. Unfortunately for AstraZeneca, that may not happen.

Continue reading AstraZeneca Stumbles over FDA Panel

AstraZeneca Stumbles over FDA Panel originally appeared on BloggingStocks on Thu, 03 Jun 2010 10:20:00 EST. Please see our terms for use of feeds.

Depomed Inc. (NASDAQ: DEPO) opened Monday on a loss of nearly 50%, as traders panned the company's clinical trial results for Serada. The drug, which is intended to treat hot flashes related to menopause, met only one one of four co-primary goals in late-stage trials after 12 weeks.

Depomed was hoping to prove that Serada could help patients achieve a "statistically significant reduction in the frequency and severity of menopausal hot flashes." However, the company confessed that the placebo effect was unexpectedly high in clinical studies.

Continue reading Depomed sinks on dismal drug news

Depomed sinks on dismal drug news originally appeared on BloggingStocks on Mon, 12 Oct 2009 11:30:00 EST. Please see our terms for use of feeds.

The U.S. Food and Drug Administration (FDA) has some questions for Genzyme Corp. (NASDAQ: GENZ) regarding trial data for its leukemia drug, Clolar. Because Genzyme didn't follow the FDA's recommendations in conducting its main study of Clolar, the regulatory agency is reluctant to make a decision on the basis of the trial results.

In 2007, FDA staff advised Genzyme to conduct a randomized study in which participants receiving Clolar would be compared against a set of patients not receiving the drug. However, the drug company's primary tests did not include a control group; instead, the treatment was tested only on elderly patients with acute myeloid leukemia (AML).

Continue reading FDA raises issues with Genzyme's leukemia drug study

FDA raises issues with Genzyme's leukemia drug study originally appeared on BloggingStocks on Fri, 28 Aug 2009 13:45:00 EST. Please see our terms for use of feeds.

Matrixx Initiatives (NASDAQ: MTXX), maker of the allegedly scent-stealing Zicam nasal swabs, tumbled to a new annual low this morning on news that the Securities and Exchange Commission (SEC) is launching an informal inquiry. The SEC is requesting documents and other information regarding the warning letter issued to Matrixx by the U.S. Food and Drug Administration.

Last week, the FDA told consumers to stop using certain nasally administered Zicam products after the agency received more than 130 complaints from users who lost their sense of smell. Matrixx has defended its homeopathic, over-the-counter offerings, calling the safety concerns "erroneous," but the firm settled hundreds of lawsuits in 2006 with consumers making the same allegations.

Continue reading Matrixx Initiatives plummets to 11-year low on SEC inquiry

Matrixx Initiatives plummets to 11-year low on SEC inquiry originally appeared on BloggingStocks on Tue, 23 Jun 2009 13:00:00 EST. Please see our terms for use of feeds.

The Brush Off: Counterfeit Colgate toothpaste found in 4 states originally appeared on BloggingStocks on Thu, 14 Jun 2007 11:45:00 EST. Please see our terms for use of feeds.