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.

What good are analysts who are consistently wrong? For instance, take Arena Pharmaceuticals (ARNA) after FDA Panel Votes Against Arena's Diet Drug Lorcaserin. How much money did their clients lose? Not all analysts work for brokerage houses, but many do, and their pay is not determined by the accuracy of their calls but the increase in sales.

How do they explain their backpedaling? One day they are pushing the stock and the next they are running for cover. Clearly they have to change their opinions based on new information, but perhaps there was too much wild speculation to begin with. More likely, they made too many false assumptions, which they love to do in a crowd so as not to be the lone incompetent.

Pharmaceutical company Vivus (VVUS) has lost more than half of its value in pre-market trading Friday. Unfortunately for VVUS, the Food and Drug Administration (FDA) rejected the company's Qnexa weight-loss drug late Thursday -- citing a lack of long-term safety data.

The news triggered a glut of downgrades and target price cuts, including downgrades from Brean Murray, Needham, JP Morgan, and Jefferies.

The drop for VVUS is understandable when considering that Qnexa is the company's main drug. There is a slight (ever-so-slight) glimmer of hope for VVUS, as the FDA is not obliged to follow the recommendations of its panels. Of course, the agency usually does follow the recommendations of its panels.

Tuesday morning, drugmaker Mylan (MYL) announced that the Food and Drug Administration (FDA) granted regulatory approval for a generic version of Arimidex, which is produced by AstraZeneca (AZN).

Reportedly, the FDA approved 1-milligram tablets of anastrozole, which is the active ingredient in AstraZeneca's Arimidex. Anastrozole is used to treat some breast cancer in postmenopausal women. This news follows Tueday's approval of a generic version of Arimidex that is produced by Teva Pharmaceutical (TEVA).

Do you suffer from heartburn? Your dreams may have just been answered. Perrigo (NASDAQ: PRGO), the world's largest manufacturer of over-the-counter pharmaceutical products for the store brand market, announced that the Food & Drug Administration has granted final approval to partner Dexcel Pharma Technologies Ltd. for OTC generic heartburn tablets.

As the exclusive U.S. marketer and distributor of Omeprazole for the over-the-counter market, Perrigo said it expects to begin shipments during the first quarter, with full-year annual sales estimated between $150 million and $200 million.

While Perrigo is officially a U.S. company, Dexcel Pharma Technologies Ltd. is headquartered in Israel. This drug is poised to be the biggest drug ever for Perrigo. Perrigo's Chairman and CEO Joseph C. Papa said, "The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo's 120-year history. While we are excited about the opportunity, we will obviously continue investing in research and development to add more new products to our product offering. The launch of Omeprazole is another example of Perrigo's dedication to make quality health care more affordable."

This is a huge win for the health-care supplier. The company raised guidance for 2008 to between $1.32 and $1.47 per share, between 20-25 cents higher than its previous forecast.

Perrigo has been a huge winner in 2007, and sure looks poised to continue moving upward in 2008.

Aaron Katsman is the lead Portfolio Manager and Managing Director of America Israel Investment Associates, LLC. and Senior Editor of IsraelNewsletter.com. Disclosure: Writer owns shares in PRGO and is long the stock as of 12/11/07.