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FDA Calendar

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Date
Company Name
Ticker
Drug
Event
Outcome
Details
08/27/2015
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
08/27/2015
Amgen Inc.
Evolocumab (BLA)
FDA decision on Evolocumab for the treatment of high cholesterol
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.
08/22/2015
Alkermes plc
Aripiprazole lauroxil (NDA)
FDA decision on Aripiprazole lauroxil for the treatment of schizophrenia
08/22/2015
Alkermes plc
Aripiprazole Lauroxil (NDA)
FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
08/11/2015
EXELIXIS INC
Cobimetinib (NDA)
FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
07/26/2015
Amgen Inc.
Kyprolis (sNDA)
FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
07/24/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA decision on Praluent for the treatment of patients with hypercholesterolemia
07/05/2015
Vertex Pharmaceuticals Inc.
Lumacaftor / Ivacaftor combo
FDA decision on Lumacaftor / Ivacaftor combo in people with CF ages 12 and older who have two copies of the F508del mutation
06/22/2015
Bristol-Myers Squibb Co.
Opdivo (BLA)
FDA decision on Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy
FDA approved Opdivo on Mar.4, 2015
06/10/2015
Amgen Inc.
Repatha (BLA)
FDA panel to review Repatha for treatment of high cholesterol
06/09/2015
Sanofi
Praluent (BLA)
FDA panel to review Praluent for the treatment of patients with high cholesterol
06/09/2015
Regeneron Pharmaceuticals
Praluent (BLA)
FDA panel to review Praluent for the treatment of patients with high cholesterol
05/27/2015
Amgen Inc.
Corlanor (NDA)
FDA decision on Corlanor to treat heart failure
FDA approved Corlanor on April 15, 2015
05/27/2015
Salix Pharmaceuticals Ltd
Xifaxan 550 mg (sNDA)
FDA decision on Xifaxan 550 mg for the treatment of irritable bowel syndrome with diarrhea or IBS-D
FDA approves Xifaxan 550 mg for the treatment of IBS-D
Pharma-Daily-052815.jpg Shares of GlobeImmune Inc. (GBIM) cratered more than 51% on Wednesday as a phase II study of GS-4774 in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment failed to meet the primary endpoint of reduction in hepatitis B surface antigen (HBsAg) at week 24.
xbiotech-052715.jpg Shares of XBiotech (XBIT) are up over 11% in pre-market trading on Wednesday as investors welcome the company's achievement of successfully isolating and cloning an anti-Ebola product candidate using its True Human antibody discovery platform.
Pharma-052615.jpg Amicus Therapeutics' (FOLD) Migalastat HCl monotherapy for Fabry patients has been granted Accelerated Assessment by the Committee for Medicinal Products for Human Use, or CHMP.
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Children who experience delayed clamping of the umbilical cord at birth may be more likely to enjoy better motor skills later in life, according to researchers at Uppsala University in Sweden. For the study the researchers followed the development of 382 healthy babies that had their umbilical cords clamped within three minutes after birth or within ten seconds of birth.
A genetically engineered version of a virus that normally causes cold sores could serve as a measure against treating skin cancer, researchers have found. Trial results, published in the Journal of Clinical Oncology, show the therapy could lengthen survival by years - but only for some melanoma patients. The modified herpes virus is harmless to normal cells.
Researchers are testing whether MDMA, the active ingredient in the drug Ecstasy, may be a useful treatment for social anxiety in adults with autism. The drug has previously been thought to boost confidence and heighten understanding of social cues, according to researchers from Stanford University and the Los Angeles Biomedical Research Institute.
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