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FDA Calendar

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PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
11/11/2015
Roche Holding AG
Cobimetinib (NDA)
FDA decision on Cobimetinib for advanced melanoma
11/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
11/04/2015
GlaxoSmithKline PLC
GSK.L, GSK
Mepolizumab (BLA)
FDA decision on Mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.
11/03/2015
Repros Therapeutics Inc.
Enclomiphene (formerly Androxal) (NDA)
FDA panel to review Enclomiphene for secondary hypogonadism in overweight men
10/27/2015
Amgen Inc.
Talimogene laherparepvec (NDA)
FDA decision on Talimogene laherparepvec for advanced melanoma
10/27/2015
Amgen Inc.
Talimogene Laherparepvec (BLA)
FDA decision on Talimogene Laherparepvec in combination with Keytruda for advanced melanoma
10/24/2015
MERRIMACK PHARMACEUTICALS, INC.
MM-398 (NDA)
FDA decision on MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
10/21/2015
Relypsa Inc
Patiromer for Oral Suspension (NDA)
FDA decision on Patiromer for the treatment of hyperkalemia
10/12/2015
Collegium Pharmaceutical, Inc
Xtampza ER (NDA)
FDA decision on Xtampza ER, an abuse-deterrent analgesic, for chronic pain
10/02/2015
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda for the treatment of patients with advanced non-small cell lung cancer
09/11/2015
Collegium Pharmaceutical, Inc
Xtampza ER (NDA)
FDA panel to review Xtampza ER, an abuse-deterrent analgesic, for chronic pain
09/08/2015
Synageva BioPharma Corp.
Kanuma (BLA)
FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
09/05/2015
TESARO, Inc.
Oral Rolapitant (NDA)
FDA decision on oral Rolapitant for the prevention of chemotherapy-induced nausea and vomiting
08/27/2015
Bristol-Myers Squibb Co.
Opdivo (sBLA)
FDA decision on Opdivo for expanded use in treating previously untreated patients with unresectable or metastatic melanoma.
08/27/2015
Amgen Inc.
Repatha (BLA)
FDA decision on Repatha for the treatment of high cholesterol
FDA approves Repatha for the treatment of high cholesterol
Pharma-082415.jpg Amgen (AMGN) has been granted FDA approval for its cholesterol-lowering medication, Repatha (evolocumab) Injection. The drug is expected to be available in the U.S. next week.
Pharma1-082615.jpg Advaxis Inc. (ADXS) has entered into a licensing agreement with Knight Therapeutics Inc. (GUD.TO) to commercialize in Canada Advaxis's product portfolio including its three lead drug candidates - axalimogene filolisbac for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors.
pharmaDaily-082415.jpg The Patent Trials and Appeal Board has ruled in favor of Acorda Therapeutics Inc. (ACOR) by denying inter parties review of the '685 patent and '826 patent of AMPYRA, the company's lead drug and a standard of care for improving walking in multiple sclerosis.
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A new report from the Centers for Disease Control and Prevention states that one out of every five children in the United States is obese. The report shows that 17.5 percent of children and adolescents ages 3 to 19 are now obese, which highly differs from the obesity rate in the late 1970s, which was 5.6 percent.
While marijuana doesn't necessarily shrink your brain cells, it does change them, according to a pair of new studies. The studies were both published in the Journal of the American Medical Association's JAMA Psychiatry. In the first study, researchers used magnetic resonance imaging to compare the brains of marijuana users to non-users.
A new study says that those who enlist the help of their primary care physician while attempting to lose weight actually drop more pounds than those who don't. The study, published in scientific journal Patient Education and Counseling, reviewed data from more than 300 obese patients who had participated in a federally-funded weight loss clinical trial.
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