Yesterday, Alexion Pharmaceuticals (ALXN) came out with strong third quarter financials. The company reported earnings per share of 29 cents, well above the Zacks Consensus Estimate of 21 cents and 23 cents reported in the year-ago quarter. Revenues increased 34% to $102.6 million from $76.5 million in the corresponding period last year, driven by strong Soliris (eculizumab) sales. However, revenues increased 44% after excluding $5.3 million of Soliris sales from the third quarter of 2008 as they were associated with the previous quarter’s shipments. Soliris posted robust sales primarily due to the addition of a significant numbers of new patients in both the US and European countries. Soliris is Alexion’s only US Food and Drug Administration (FDA) approved (approval received in March 2007) product used for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), a life threatening blood disorder. The drug had received European Commission (EC) approval ...

Cephalon, Inc. (CEPH) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Nuvigil. The company had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Priority review status means that a response from the agency will be out in six months instead of the usual 10-12 month review period. As such, a response from the FDA should be out by December 29, 2009. Nuvigil is Cephalon’s follow-on sleep franchise product which received FDA approval in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Cephalon launched Nuvigil in June 2009 and is promoting the product aggressively. The company has ...

We await the outcome of the US Food and Drug Administration’s (FDA) advisory panel meeting scheduled for today that will decide on various aspects of human papillomavirus (HPV) vaccines. Primarily there are two vaccines available for the prevention of cervical cancer in women -- Merck’s (MRK) Gardasil and GlaxoSmithKline’s (GSK) Cervarix. Both vaccines are given in a series of three shots over a six-month period. Although Cervarix is approved in several countries, it has yet to gain FDA approval. In June 2006, the FDA approved the first cervical cancer vaccine, Gardasil (which targets four HPV strains: HPV 6, HPV 11, HPV 16 and HPV 18) for females 9 to 26 years of age. The FDA panel will decide on the approval of Cervarix (targets two HPV strains, HPV 16 and HPV 18) in females 10 to 25 years of age. In addition, the vaccine ...

For Immediate Release

Chicago, IL – August 4, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Bristol-Myers Squibb Co. (BMY), AstraZeneca Plc (AXN), Merck (MRK), Novartis (NVS) and Medarex (MEDX).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Monday’s Analyst Blog:

FDA Approves Bristol’s Diabetes Drug

We are pleased with the FDA’s approval of Bristol-Myers Squibb Co.’s (BMY) diabetes drug Onglyza that the company distributes with AstraZeneca Plc (AXN). The drug regulates blood-sugar levels in Type 2 diabetes that affects about 24 million people in the U.S.

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We are pleased with the FDA’s approval of Bristol-Myers Squibb Co.’s (BMY) diabetes drug Onglyza that the company distributes with AstraZeneca Plc (AZN). The drug regulates blood-sugar levels in Type 2 diabetes that affects about 24 million people in the U.S. The approval is a major milestone for Bristol-Myers for penetrating the diabetes market, which has grown to more than $5 billion in the US.

The FDA approval comes against the backdrop of controversy on cardiovascular safety of diabetes drugs. Though data from clinical trials conducted by Bristol-Myers did not show any evidence of cardiovascular risk, the FDA has asked for a post-approval study to evaluate the drug’s safety in higher-risk patients including the elderly and those with existing heart problems. Onglyza has side effects of upper-respiratory-tract and urinary-tract infections and headaches along with certain allergic reactions such as rashes.

Being structurally similar to Merck’s (MRK)

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There has been a lot of chatter lately—since John Bogle dropped his "investors are getting fleeced in ETFs" bomb two weeks ago—that the average Joe just isn't going to do very well in ETFs because he'll be getting in when he should get out, and vice versa.

Well, let's see how the "average" ETF investor did in the month of June. We don't have numbers on how asset flows changed during the last 30 days yet, although our friends at the National Stock Exchange are sure to get us that soon. But what we do know is the bets investors, as a mass of men and women leading lives of quiet desperation, made at the beginning of the month.

As a refresher, here were the assets of leading ETFs at the end of May (in billions of dollars):

 

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CYCC: Focus on Key Programs to Conserve Resources

Cyclacel Pharmaceuticals, Inc. (CYCC) is a clinical-stage company dedicated to the discovery, development, and commercialization of small molecule cell cycle inhibitors for the treatment of cancers and other serious disorders. The company's expertise lies in the area of Cell Cycle Inhibition which is a mechanism-targeted approach for the treatment of cancer and other serious proliferative diseases.

Cyclacel aims to develop novel, cell-cycle-based mechanism-targeted cancer therapies that will stop the growth of cancer cells and will limit the damage caused to normal cells. The company strives to develop anticancer drug candidates in all phases of the cell cycle and multiple compounds for particular cell cycle targets.

Relatively deep pipeline, but most are in early or middle stages of development

The company's lead development candidate, CYC682 (Sapacitabine), is an oral nucleoside analogue which is undergoing a

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GM Cans Mid-Size Trucks; Treasury Yields Soar to 7-month High; Airlines Grounded by $9 Billion Loss; Copper Sinks as Dollar Rises; Supreme Court Delays Chrysler Sale; McDonald’s misses estimates; Apple debuts new iPhone

After repeated attempts to sell its medium-duty truck operations,General Motors Corp. (OTC: GMGQ), yesterday (Monday) said that it would halt their production by July 31. Reuters reported. “After four years of working with multiple potential buyers, General Motors has decided to wind down its medium-duty truck operations,” the automaker said in a statement.  GM plans to cease production of Chevrolet Kodiak and GMC Topkick. The automaker sold about 20,000 of the vehicles last year, down from roughly 30,000 in 2007, as the U.S. economy sank into a deep recession. Yields on two-year treasuries soared to the highest level since November, as investors expressed concern that record issuance of U.S. debt may overwhelm demand ...

6th Case of PML Found in Tysabri PatientsThis past weekend, Biogen Idec, Inc. (BIIB) reported that another patient taking Tysabri had developed a case of progressive multifocal leukoencephalopathy, or PML.This is the sixth case of PML since July 2008. In the most recent case, a patient being treated for multiple sclerosis on Tysabri developed the disease after 31 months. All patients are taking Tysabri as a monotherapy, with the minimum therapy before noted disease of 12 months. The average length of time for the sixth patients dosing is 19 months. Five of the six reported cases were located outside the U.S.Despite the new case of PML, Biogen Idec and Elan continue to educate and train physicians under the risk management plan (RiskMAP). This includes the recent warning on potential liver damage as well. As of the end of the first quarter, there ...