OncoGenex Pharmaceuticals Inc has recently announced that the Food and Drug Administration panel has approved their additional fast-track designation to their new prostrate cancer drug, OGX-011, in combination with the first-line chemotherapy. The news about the approval of cancer drug by FDA sent OncoGenex Pharmaceuticals’ shares up on the market charts. This fast-track designation is structured to expedite the review of drugs used for the treatment of serious disease and to fill in unmet medical needs. Most of the drugs that are eligible for the designation are likely to receive a priority review. It is easier for the FDA to make their decisions quickly to approve drugs once they have received a priority review.

OncoGenex Pharmaceuticals have already received a fast-track status for second-line treatment with their OGX-011 in combination with

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Genzyme Corp.’s (GENZ) Clolar could face a delay in receiving approval for an expanded indication. The drug will be coming up for review before the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on Sept 1 and questions have been raised regarding the lack of a randomized study supporting the application.

The company is seeking to get Clolar approved for the treatment of previously untreated adults aged 60 or older with acute myeloid leukemia (AML) who have at least one unfavorable prognostic risk factor. The company is seeking approval on the basis of a phase II study in which Clolar was evaluated in elderly patients with previously untreated AML and at least one other factor that gave them a poor prognosis. The study did not include any comparison with a placebo.

Clolar is currently approved for pediatric acute lymphoblastic leukemia (ALL) patients who have relapsed or refractory

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SGX Pharma (Nasdaq: SGXP) 6-Month Chart

Shares of SGX Pharma (SGXP) soared after hours Tuesday on news of an all-cash $64 million buyout from Eli Lilly (LLY). The buyout represented a premium of more than 100% at $3 per share for SGX, which is being acquired for its drug discovery platform focused on oncology. The two companies have collaborated since 2003, and the deal is expected to close during the second half of the year.

Recently, several buyouts at 100%-plus premiums for micro-cap biotechs such as cancer drug developer Kosan Biosciences (KOSN) by Bristol-Myers (BMY) and Barrier Therapeutics by privately-held Stiefel Labs have taken place as larger pharmaceutical companies look for deals to bolster their pipeline and product portfolio. Also, shares of many small and micro-cap biotechs are trading at multi-year or all-time lows as risk-averse investors have avoided the entire group in response to bear market …

The Masters haven't mentioned Onyx Pharmaceuticals Inc (NASDAQ:ONXX) in a long time, since our 100%+ gain with our Master Picks Newsletter.  Barron's is jumping on the bandwagon now that shares are down to $33.  Can Nexavar, Onyx's cancer drug take the company and stock back into the spotlight? Onyx Pharmaceuticals Inc's (NASDAQ:ONXX) cancer drug has bright potential in treating several forms of the disease and could raise the biotech company's shares, according to a report on Sunday in Barron's (Paid portion only, thus no link provided). With sales of its drug Nexavar, now approved to treat kidney and liver cancer, expected to hit $1 billion next year, Barron's said one health-care investor is looking for earnings of $1.93 per share, and valuing the stock at $65 to $75 per share....