Summary Rapivab may just pass its December 23 PDUFA date with the FDA based on one conclusive Phase 2 result over placebo and minimal safety issues. Rapivab's only effective formulation (IV infusion) limits its utility and earning potential. Seeking Alpha, 1 day ago
PDUFA date approaches for AbbVie HCV combo therapy - Seeking Alpha, 1 day ago
PDUFA date approaches for Cubist antibiotic combo - Seeking Alpha, 1 day ago
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To screen ETFs by asset class, performance, yield and more, check out the ETF Hub.Seeking Alpha, 1 day ago
Friday, December 5 is the PDUFA date for the FDA's review of Incyte's (INCY -1.7%) Jakafi (ruxolitinib) sNDA for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is ...Seeking Alpha, 2 weeks ago FDA clears Jakafi for PV Seeking Alpha, 2 weeks ago
Summary PDUFA decisions have the potential to increase share prices as investor anticipation and attention grows in advance of the FDA decision. The primary catalysts that we are looking for when investing in a catalytic event is a PDUFA date (a ...Seeking Alpha, 2 weeks ago
Salix Pharmaceuticals Provides Updates on Wholesaler Inventory Reductions and the XIFAXAN® 550 for IBS-D Approval Timeline, and Provides Preliminary Guidance for 2015 and 2016
Expects to Achieve Wholesale Inventory Targets by Year End 2015 Announces Extension of PDUFA Action Date for XIFAXAN 550 for IBS-D to May 27 Provides Preliminary Guidance for Full Years 2015 and 2016 RALEIGH, N.C.--(BUSINESS WIRE)--Dec. 16, ...BusinessWeek, 3 days ago Salix Pharmaceuticals : Provides Updates on Wholesaler Inventory Reductions and the XIFAXAN® 550 for IBS-D Approval Timeline, and Provides Preliminary Guidance for 2015 and 2016 4 Traders, 3 days ago Salix Pharmaceuticals Sees 2015 Below Estimates Earnings Whispers, 3 days ago
Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the ...Friends of Cancer Research, 4 hours ago
A little more than a year after Sanofi ( $SNY ) stepped in to sign a development deal with Pozen, the pharma giant has stepped back out just weeks ahead of a scheduled PDUFA date. Chapel Hill, NC-based Pozen ( $POZN ) says the pharma giant and the ...FierceBiotech, 2 weeks ago Pozen and Sanofi US End Agreement for PA8140/PA32540 Individual.com, 2 weeks ago POZEN and Sanofi Terminate Partnership for PA8140/PA32540 PharmaceuticalProcessing, 2 weeks ago Up-to-$35M Sanofi-Pozen Partnership Ends for Advanced Aspirins Genetic Engineering News, 2 weeks ago
Editor The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated ...Seeking Alpha, 10 minutes ago FDA Approves Second Cubist Antibiotic Of 2014 Forbes.com, 16 minutes ago
Amarantus Bioscience Holdings, Inc. (AMBS: OTCQB) | Amarantus Submits Orphan Drug Designation Application to US FDA for Treatment of Retinal Artery Occlusion With Product Candidate MANF
SAN FRANCISCO and GENEVA, Dec. 19, 2014 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of ...Pink Sheets, 10 hours ago Amarantus Submits Orphan Drug Designation Application to US FDA for Treatment of Retinal Artery Occlusion With Product Candidate MANF Stockwatch, 11 hours ago Amarantus BioSciences, Inc. Submits Orphan Drug Designation Application To U.S. FDA For Treatment Of Retinal Artery Occlusion With Product Candidate MANF BioSpace, 8 hours ago
Notice of public meeting; request for comments. Citation: "79 FR 75822" Document Number: "Docket No. FDA-2014-N-2137" Page Number: "75822" "Notices" SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public ...Pharmacy Choice, 5 hours ago Patient-Focused Drug Development Public Meeting on Chagas Disease Pharmacy Choice, 1 week ago FDA Focus: Life-threatening disease and the benefit-risk of treatment options Pharma Letter, 1 week ago
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