fda posts
FeedPosted Dec 27th 2010 2:00PM by Mark Fightmaster (RSS feed)
Filed under: Bad News

Biopharmaceutical firm Alimera Sciences (
ALIM) is considerably lower Monday (more than 16% at the time of writing) thanks to news that regulators have declined to approve it treatment for retinal swelling. The FDA sent Alimera a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Alimera's investigational drug ILUVIEN saying that it
can not approve the drug in its current form. While the CRL didn't request new studies, it asked for analyses of the safety and efficacy data through month 36 of the FAME Study - which includes exploratory analyses and those previously submitted to the FDA. These analyses will be done to further assess the benefits and risks of ILUVIEN. The original New Drug Application (NDA) only included data through 24 months.
Continue reading Alimera Sciences Plummets on FDA Decision
Posted Nov 15th 2010 11:30AM by Elizabeth Harrow (RSS feed)
Filed under: Major Movement, Analyst Reports, Options
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
Posted Oct 11th 2010 4:30PM by Jon Ogg (RSS feed)
Filed under: International Business Machines (IBM), CIT Group (CIT), Potash Corp. of Saskatchewan (POT)

With bonds closed and banks closed, equities here in the U.S. had a hard time trying to decide which direction the wind was blowing. The
DJIA 11,000 mark was flirted with again in afternoon trading, this time on the downside on what appears to have been a positive close. Some M&A was a help, but investors used today and will likely use tomorrow to determine how they want to be positioned as
earnings season kicks off.
Here were today's unofficial closing levels:
Dow Jones 11,008.59 +2.11 (0.02%)
S&P 500 1,165.04 -0.11 (-0.01%)
Nasdaq 2,402.33 +0.42 (0.02%)
TOP ANALYST CALLS
BIOHEALTH DAILYContinue reading Closing Bell: Preparing for Earnings, with Bonds Closed (GYMB, ALXA, IBM, DLTR, CIT, POT)
Posted Sep 30th 2010 4:00PM by Mark Fightmaster (RSS feed)
Filed under: Novartis AG ADS (NVS)

According to Bloomberg, Novartis AG (
NVS) has agreed to pay
$422.5 million in order to resolve criminal and civil investigations into the marketing of Trileptal -- an epilepsy drug. The U.S. Attorney's Office in Philadelphia announced that NVS will plead guilty to a misdemeanor and pay a $185 million fine.
NVS has also agreed to pay $237.5 million in order to resolve civil allegations over Trileptal's promotion for uses not approved by the U.S. FDA. The settlement brings to an end several lawsuits that were filed by whistleblowers citing the False Claims Act -- which allows private citizens to sue on behalf of the government and share in any recovery.
Continue reading Novartis Agrees to Pay $422.5 Million for Settlement
Posted Sep 22nd 2010 11:10AM by Mark Fightmaster (RSS feed)
Filed under: Johnson and Johnson (JNJ)
Reportedly, a U.S. House committee found a bit more about Johnson & Johnson (JNJ) recalls than it wanted during a recent investigation into last year's recalls. Remember, Johnson & Johnson had a massive recall of some of its over-the-counter (OTC) medicines.
Turns out that the House Committee on Oversight and Government Reform announced Tuesday that it obtained an e-mail highlighting an agreement between the FDA and Johnson & Johnson that would allow the company to "conduct an unpublicized recall of adult Motrin." Motrin is produced by Johnson & Johnson's McNeil consumer medicines, and this is the unit that was allowed to carry out the "phantom recall."
Continue reading Johnson & Johnson, the FDA and a Phantom Recall
Posted Sep 14th 2010 12:30PM by Elizabeth Harrow (RSS feed)
Filed under: Major Movement, Bad News, Options
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
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