For the first time in seven years, a new therapy for Chronic Lymphocytic Leukemia [CLL] has been cleared in the U.S. by the FDA. Biotech firm Cephalon’s (CEPH) Treanda (bendamustine hydrochloride) was given final approval by the FDA on March 20, only six months after the company submitted the NDA in September of 2007.

CLL is one of the four main types of leukemia, and is characterized by a slow progression of abnormal white blood cells (lymphocytes) in the bone marrow, usually spreading to other parts of the body, including lymph nodes, liver, spleen, and the central nervous system.

I know this is supposed to be a blog covering the biotechnology and medical industry, but in an unprecedented move for this blog, a major non-health related event will have to be commented on.

Bear Steans (BSC) was forced to sell itself to JP Morgan (JPM) for a whopping $2 a share, equal to $236 million in total! The company was worth over $20 billion just a couple of months ago, representing a drop of over 90%.

When it comes to creating drugs to combat the world’s most devastating diseases, established pharmaceutical companies sometimes prefer extending the lifecycle of existing drugs to developing truly new and groundbreaking treatments.

But as the US Food and Drug Administration’s most recent standards emphasize, it is crucial that pharmaceutical companies stay focused on their core mission – bringing genuinely new medicines and treatments, ones with revolutionary, disease-modifying potential, to the pharmaceutical market.

Shares of Allergan (AGN) plunged almost 6% on Friday following an announcement by the FDA that the agency launched a safety review of the company's flagship product, BOTOX, and Solstice Neuroscience's competing product Myobloc. Shares of Medicis (MRX), which is investigating a potential competing product through clinical trials, also dropped on Friday in sympathy.

As usual, Wall Street traders, whose majority do not know what chromosomes are, let alone the actual link between botulinism toxin and BOTOX, have over-reacted to mundane news; a common event with biotech stocks. What is even more common is the incident that spurred the over-reaction; the FDA continues to monitor drugs long after approval, especially off-label use.

In what might be the greatest coincidence in Wall Street history, IDM Pharma (IDMI) stock skyrocketed by 234% on Tuesday as the company announced positive late stage results of its Osteosarcoma drug L-MTP-PE.

What is the coincidence you ask? On Monday the Nasdaq released a letter to the company warning that its stock has not met the $1 minimum required bid price over the last 30 days in order to keep its listing on the exchange.

Shares of Somanetics Corp (SMTS) jumped 6.82% on Thursday as volume surged almost three times the three-month daily average! There were no news or any significant events that could be detected.

Somanetics develops, manufactures, and markets medical devices primarily in the United States. It offers the INVOS System, a non-invasive patient monitoring system that provides continuous information about changes in blood oxygen saturation levels in patients with or at risk for restricted blood flow.

The Dow Jones was down by 450 points early Wednesday before finishing the day up by almost 300 points in the second wild trading session in a row since the Fed cut rates by 75 points early Monday. Nasdaq also gained big rising more than 1%.

But the major biotech indices did not follow along as the Amex Biotech Index [BTK], heavy with large cap biotechs, lost more than 2%, while the Nasdaq Biotech Index [NBI] slipped 0.30%.

Geneva-based Covalence is publishing Wednesday its third annual ethical reputation ranking, giving the best ranked companies as well as those companies which have made the most progress in 2007.

Below are those companies with the best ethical scores in the Pharmaceutical and Biotechnology sector.

In Thursday's edition of the Wall Street Journal, the feature article focused on the grim future of big pharmas, as old ways of doing business, top drugs facing loss of patent protection coupled with increasing competition from generics, and dried up pipelines adding up to a not so bright horizon.

In fact, Wall Street has built the negative view of big pharma into the market price of many stocks. The Dow Jones World Index gained 75% over the last six years, while the FTSE Global Pharmaceuticals Index dropped almost 20%.

Dai Jialing submits: China’s State Food and Drug Administration approved a research and development license Nov. 20 for Aoxing Pharmaceutical's (CAXG.OB) opioid combo tablet buprenorphine/naloxone tailored to fight the growing problem of opioid dependence in China.

Marketed under the brand name Suboxone and manufactured by Reckitt Benckiser in the U.S., buprenorphine/naloxone is "the first opioid medication approved under the Drug Addiction Treatment Act of 2000 for the treatment of opioid dependence in an office-based setting,” Shao Hui, Aoxing’s senior vice president of finance, told PharmAsia News. “The primary active ingredient in Suboxone is buprenorphine and because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin.”

What must be the strangest stock offering in my trading career, Protalex Biotherapeutics (PLX) sold 10 million additional shares on the market Thursday at $5 per share. Why strange? Because the stock closed at $36 a share on Wednesday! The stock's wild trading session Thursday ended at a price of $6.31.

Why would the company sell their stock at a price so much lower than market valuation? Even more strange: Phillip Frost, the founder of IVAX and the main player behind recent successful stocks such as Ladenburg Thalmann Financial Services (LTS) and Opko (OPK), held around 11% of Protalex stock. That means Dr.Frost lost more than $200 million after the stock offering. This is not indicative of his investment track record - not even close.

Jonathan Houssian, President and Founder of RxElite (subsidiary of Southridge Enterprises (SOUT.OB)) discusses the company's generic drug business in a changing political climate, and outlines upcoming financial milestones for investors.

Give us a brief historical overview of RxElite, its incorporation and business focus.

Adventrx Pharmaceuticals (ANX) shares absolutely crashed on Monday by almost 80% as the company announced that a phase 2b clinical trial for its metastatic colorectal cancer treatment:

...did not demonstrate statistically significant improved safety in the trial's primary endpoint, a reduction in the proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater.

The company's shares closed at more than $2.50 last Friday before opening Monday's session at $0.81 and ended the day at $0.55. The company is now discussing the future course of this program, but is still optimistic about the other two programs ANX-530 and ANX-514.

Stem cell research has been one of the most controversial medical, scientific, and political issues of the last decade. Conservative outcries against the use of embryos to harvest multi-potent stem cells have been loud and clear, while the liberal viewpoint that early cells do not constitute "life" and should be used for medical research has been equally strong.

But the majority of stem cell research around the world should not fall within the realm of these debates, as a larger percentage of stem cells used by researchers are harvested from umbilical cords of newborns and adult tissue, such as skin, nasal lining, and even teeth.

According to the company;

Adam Feuerstein and James Altucher can both attest to the large following their Dendreon posts attract. So can 247WallSt, and so can I.

Typically, the success of cancer treatments in clinical trials is measured by the reduction in the size of tumors. This was apparently the reason why the FDA refused to give Provenge final approval, citing that the average size in prostate tumors did not significantly shrink.

Topic:
Investment Opportunities in Healthcare

This prompted Punk, Ziegel & Co. to raise its outlook on Corcept stock from "market perform" to "accumulate."

What was really impressive about this three day rally is how strong the volume has been, signaling that large institutional investors might be involved. Volume over three days, Thursday, Friday and Monday, was 538,400 / 891,300 / 822,967 respectively, while the 3-month daily average volume is a little over 70,000 according to Yahoo!Finance.

The company's board of directors approved the stock offering, but did not disclose the anticipated date of the filing, the expected price nor the overall size of the deal. Yet, investors welcomed the news as volume was 8x the 3-month daily average.