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Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates
Wednesday, February 28, 2018 - 11:08am | 835Read More...The FDA decided favorably on four of the six major PDUFA decisions due in February, with Valeant Pharmaceuticals Intl Inc (NYSE: VRX)'s Salix Pharma unit and its partner Norgine announcing an extension the PDUFA action date for Plenvu by three months to May 13, 2018, citing the time needed to...
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Johnson & Johnson, Tesaro Niraparib Trial Enrollment Suspension Not Related To Safety
Friday, June 9, 2017 - 12:18pm | 272Read More...TESARO Inc (NASDAQ: TSRO) fell as much as 9.8 percent Friday on news that Johnson & Johnson (NYSE: JNJ) suspended the enrollment of their shared phase 2 niraparib trial for prostate cancer. A Johnson & Johnson spokesperson told Benzinga the temporary hold isn't related to safety, and...
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What Happened To Cempra's PDUFA Dates?
Thursday, December 29, 2016 - 9:30am | 332Read More...Cempra Inc (NASDAQ: CEMP) investors, whose shares had taken a pounding in early November, were waiting for a couple of big catalysts that could drive a rebound this week. The FDA had set two target dates to take action on solithromycin under the PDUFA: On Tuesday, it would make a decision for...
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Getting Into The Drug Business: From NDAs To PDUFA Dates
Tuesday, September 27, 2016 - 2:20pm | 665Read More...The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, they’ll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, they’re greeted with unfamiliar acronyms. Let...
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Pain Therapeutics Gains 7%, FDA Has Accepted Company's Remoxy For Review
Wednesday, April 13, 2016 - 11:32am | 179Read More...Shares of Pain Therapeutics, Inc. (NASDAQ: PTIE), a micro-cap biopharmaceutical company whose lead drug candidate, REMOXY, is used for the treatment of moderate to severe pain. Pain Therapeutics announced after Tuesday's market close the U.S. Food and Drug Administration determined that its...
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Acadia Pharmaceuticals Are Spiking
Monday, February 1, 2016 - 9:55am | 217Read More...Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) were trading higher by nearly 9 percent early Monday morning. Acadia Pharmaceuticals announced after Friday's market close that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration will review data...
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Goldman Comments On Vertex Pharmaceuticals Following FDA Approval
Thursday, July 2, 2015 - 1:41pm | 242Read More...Shares of Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) were trading higher by nearly 4 percent on Thursday after the FDA approved the company's Orkambi (lumacafor/ivacaftor) for the treatment of cystic fibrosis patients 12 years and older. Commenting on the FDA's approval, Terence Flynn, PhD...
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Here's What Canaccord Learned After Spending A Day With Synageva's Management
Thursday, May 7, 2015 - 3:30pm | 280Read More...In a report published Thursday, Canaccord Genuity analyst Adam Walsh, MD detailed a recent meeting with Synageva Biopharma Corp (NASDAQ: GEVA)'s management team and came away "more positive" on the LAL-D commercial opportunity. Separately, Synageva has announced that Alexion Pharmaceuticals, Inc. (...
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Amarin and Horizon Pharma Higher Ahead of PDUFA Dates
Monday, July 23, 2012 - 3:06pm | 157Read More...Horizon Pharma (NASDAQ: HZNP) and Amarin (NASDAQ: AMRN) both have upcoming Prescription Drug User Fee Act dates on Thursday. PDUFA refers to the fees that the FDA collects from drug manufacturers and allocates towards a drug's review process. The FDA traditionally makes an effort to complete its...
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Biotechs With Upcoming PDUFA Dates
Wednesday, July 18, 2012 - 3:09pm | 871Read More...On Tuesday, the FDA approved the second weight-loss drug in the last 13 years when it green-lighted Vivus' drug Qsymia. On Wednesday, VVUS shares have shot up more than 14 percent to $30.27. The approval of this drug and the excitement that it has created in the biotech investing community may...
