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US42366C5094 HEB

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HEMISPHERX BIO : 5 High-Profile Drugs Expect FDA Decisio

31 janv. 201321:00

5 High-Profile Drugs Expect FDA Decisions in February

Read more:
http://www.minyanville.com/sectors/biotech-pharma/articles/5-High-Profile-Drugs- Expect-FDA/1/31/2013/id/47803#ixzz2JaKqOlDj

Mark these dates on your calendars before you slog through the frigid month of February. There are a number of important catalysts for drug and biotech investors in the month.

There aren’t a lot of expected drug approval decisions in February, but there are some high-profile treatments facing key dates. There’s also a big gathering of biotech CEOs in New York and a cancer research meeting in Florida. Expect news from both events.

Below are some of the highlights for drug and biotech investment events in the month of February. As always, some dates are subject to change.

Read more:
http://www.minyanville.com/sectors/biotech-pharma/articles/5-High-Profile-Drugs- Expect-FDA/1/31/2013/id/47803#ixzz2JaKxKRKN
February 2
Hemispherx BioPharma (NYSEAMEX:HEB) is scheduled to hear from the Food and Drug Administration on potential market clearance for Ampligen, a treatment for chronic fatigue syndrome. A panel of expert advisers to the FDA voted last month that Ampligen should not be approved because the company hadn’t clearly demonstrated the drug works. That panel was preceded by a harsh report from FDA staffers who rapped Hemispherx for its clinical data. (See also: Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review.) Note that the decision date is Saturday. Be on the lookout for news Friday, February 1.

February 10
Celgene (NASDAQ:CELG) expects to hear from the FDA on the possible approval of Pomalyst (pomalidomide) to treat multiple myeloma. CEO Robert Hugin predicts the drug will be a blockbuster product for the big biotech company. (See also: Celgene Rises After CEO Hugin Touts New Drugs, Sales Growth.)

February 11
The BIO CEO & Investor Conference takes place in New York through February 12. The event features presentations by dozens of companies. CEOs from several companies will be in the spotlight during public interviews with industry analysts. They include Celgene’s Hugin as well as chiefs from Eli Lilly (NYSE:LLY), Onyx Pharmaceuticals (NASDAQ:ONXX), Gilead Sciences (NASDAQ:GILD), and BioMarin Pharmaceutical (NASDAQ:BMRN).

February 14
The Genitourinary Cancers Symposium runs through February 16 in Orlando, Florida. Treatments for prostate, kidney, bladder, and other cancers will be highlighted at this conference of the American Society of Clinical Oncology. Medivation (NASDAQ:MDVN) and partner Astellas Pharma will attract considerable attention with updated study data on the prostate cancer drug Xtandi. The research findings on Xtandi in early stage prostate cancer patients will be particularly important.

February 24
Dynavax Technologies (NASDAQ:DVAX) is scheduled to hear from the FDA on an application to sell Heplisav, an adult vaccine for hepatitis B. Shares of the company plummeted in November after a government panel review raised questions about the product’s safety. (See also: Dynavax Technologies’ Stock Plunges on Vaccine Safety Concern.) Dynavax has said the market for a hepatitis B vaccine is $700 million per year. Merck (NYSE:MRK) and GlaxoSmithKline (NYSE:GSK) currently have products on the market.

February 26
ImmunoGen (NASDAQ:IMGN) and Roche (PINK:RHHBY) expect a decision from the FDA on the breast cancer treatment trastuzumab emtansine, T-DM1. The drug combines ImmunoGen’s chemotherapy with Roche’s Herceptin. While Wall Street analysts expect the treatment to be approved, some investors were miffed that ImmunoGen didn’t sign a better agreement with Roche. (See also: ImmunoGen Shares Drop on Roche Drug Royalty Payments.)

Other potential events to watch in February:
Diet pill maker Arena Pharmaceuticals (NASDAQ:ARNA) is still awaiting word from the Drug Enforcement Administration for scheduling of the drug Belviq. The DEA needs to classify the drug because of risk for abuse.

Biogen Idec (NASDAQ:BIIB) is scheduled to hear from the FDA by late March on approval of its multiple sclerosis pill, Tecfidera. But the agency may make a decision earlier given that it’s already delayed a ruling on the drug once. One complication: Rival Teva Pharmaceutical Industries (NYSE:TEVA) is trying to convince the agency to reject the Biogen drug. (See also: Teva Aims to Derail Approval of Biogen Idec’s MS Pill.)

Read more:
http://www.minyanville.com/sectors/biotech-pharma/articles/5-High-Profile-Drugs- Expect-FDA/1/31/2013/id/47803#ixzz2JaL3pR9S

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