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What Movie Theaters Don't Want You to Know About the $6 Popcorn!

popcornMovie theaters don't want you to know how many calories are in the popcorn and that's why they are resisting FDA attempts at requiring disclosures. If the FDA required scales in front of the popcorn counters, or that all popcorn be sold with free carrots, I might side with the theaters, but requiring one of those small nutritional information panels on the back of the popcorn bucket -- eaten in a darkened theater -- hardly seems oppressive to me.

I'm all for free choice and I don't want to take away anyone's jumbo popcorn as they go to the movies -- unless, of course, I get to eat some of it.

Continue reading What Movie Theaters Don't Want You to Know About the $6 Popcorn!

FDA Menthol Report Good News for Lorillard

LO logoLorillard (LO - option chain) shares are rising today after an FDA panel wrote in a draft report that it will not recommend an outright ban on menthol cigarettes. Most of LO's sales come from menthol products, unlike its main competitors Altria (MO) and Reynolds American (RAI). Investors had feared the FDA would move to ban menthol cigarettes, but that is looking less likely now, even though the panel did say removing menthol from the shelves would benefit public health. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on LO.

LO opened this morning at $80.01. So far today the stock has hit a low of $79.30 and a high of $88.17. As of 12:15, LO is trading at $85.67 up 6.89 (8.8%). The chart for LO looks bullish and S&P gives LO a positive 4 STARS (out of 5) buy ranking.

Continue reading FDA Menthol Report Good News for Lorillard

FDA Approves Generic Cancer Treatment from Hospira

HSP logoHospira (HSP - option chain) shares are rising today after the company announced that the FDA has approved its generic cancer treatment docetaxel. The brand-name drug it will compete against, Sanofi-Aventis' (SNY) Taxotere, had sales of $1.2 billion in 2010. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on HSP.

HSP opened this morning at $53.66. So far today the stock has hit a low of $53.55 and a high of $56.00. As of 12:05, HSP is trading at $54.65 up $1.02 (1.9%). The chart for HSP looks bullish and S&P gives HSP a positive 4 STARS (out of 5) buy ranking.

Continue reading FDA Approves Generic Cancer Treatment from Hospira

Vertex Sees Positive Cystic Fibrosis Drug Results

VRTX logoVertex Pharmaceuticals (VRTX - option chain) shares are rising today after the company reported successful results from a study of its experimental cystic fibrosis treatment VX-770, allowing the company to apply for FDA approval for the drug later this year. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on VRTX.

VRTX opened this morning at $43.60. So far today the stock has hit a low of $42.71 and a high of $44.68. As of 12:10, VRTX is trading at $43.77 up $5.55 (14.5%). The chart for VRTX looks bullish and S&P gives VRTX a positive 5 STARS (out of 5) strong buy ranking.

Continue reading Vertex Sees Positive Cystic Fibrosis Drug Results

MannKind's Inhaled Insulin Verdict Delayed by FDA

MannKind (MNKD) logoPharmaceutical company MannKind (MNKD) shares have traded considerably higher this morning, gaining 9% shortly after the opening bell and trading in the upper $8 region. It appears that the rally was sparked by news that the U.S. Federal Drug Administration would not be able to complete a review of the company's inhaled insulin Afrezza by December 29.

The FDA added that it will need roughly four more weeks to complete the review. Back in July, the FDA accepted a resubmission on Afrezza and classified it a class 2 response.

Continue reading MannKind's Inhaled Insulin Verdict Delayed by FDA

Alimera Sciences Plummets on FDA Decision

FDA logoBiopharmaceutical 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

Cumberland Pharma Plummets After FDA Rejection

Cumberland Pharmaceuticals (CPIX) logoShares 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

Mela Sciences Surges Ahead of FDA Panel

Mela Sciences logoMela 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

Human Genome Sciences Drops Ahead of FDA Meeting

Human Genome Sciences (HGSI - option chain) stock is trading lower today after briefing materials for an FDA advisory panel were released that questioned whether the benefits of Benlysta, a proposed lupus treatment from HGSI and GlaxoSmithKline (GSK), outweighed its risks. The panel will potentially vote next week on whether it thinks Benlysta should be approved, but its early skepticism might not be a good sign for HGSI and GSK and speculation surrounding the event has driven option prices through the sky. If you think this stock won't be rising too far in the coming months, then it could be a good time to look at a bearish hedged play on HGSI.

Continue reading Human Genome Sciences Drops Ahead of FDA Meeting

Allergan's Botox Approved for Migraine Treatment

AGN logoAllergan (AGN - option chain) shares are rising today after the company announced FDA approval of Allergan's Botox for use as a treatment for chronic Migraine headaches on Friday after the close of trading. This opens an entirely new market for that drug, which was almost exclusively used for cosmetic purposes. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on AGN.

AGN opened this morning at $71.97. So far today the stock has hit a low of $71.14 and a high of $72.56. As of 12:10, AGN is trading at $72.43 up $3.57 (5.2%). The chart for AGN looks bullish and S&P gives AGN a positive 4 STARS (out of 5) buy ranking.

Continue reading Allergan's Botox Approved for Migraine Treatment

Closing Bell: Preparing for Earnings, with Bonds Closed (GYMB, ALXA, IBM, DLTR, CIT, 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%)

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Continue reading Closing Bell: Preparing for Earnings, with Bonds Closed (GYMB, ALXA, IBM, DLTR, CIT, POT)

FDA Approves WCRX Osteoperosis Drug

WCRX logoWarner Chilcott (WCRX - option chain) shares are rising today after the Food and Drug Administration approved its next generation ACTONEL product for the treatment of postmenopausal osteoporosis. WCRX will market the drug as Atelvia. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on WCRX.

WCRX opened this morning at $23.00. So far today the stock has hit a low of $22.88 and a high of $24.34. As of 12:10, WCRX is trading at $23.75 up 1.50 (6.7%). The chart for WCRX looks neutral and S&P gives WCRX a neutral 3 STARS (out of 5) hold ranking.

Continue reading FDA Approves WCRX Osteoperosis Drug

Novartis Agrees to Pay $422.5 Million for Settlement

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

Johnson & Johnson, the FDA and a Phantom Recall

Johnson & Johnson (JNJ) logoReportedly, 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

Arena Pharmaceuticals Hammered by FDA Concerns

Arena Pharmaceuticals logoArena 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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Symbol Lookup
IndexesChangePrice
DJIA-89.2312,801.23
NASDAQ-23.352,903.88
S&P 500-9.311,342.64

Last updated: February 10, 2012: 06:38 PM

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