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News Breaks
June 12, 2014
07:44 EDTAZN, NKTR, SLXP, PGNXFDA Anesthetic & Analgesic Drug Products Advisory Committee holds a meeting
The Committee reviews opioid antagonists being developed for opioid induced constipation including Progenics' and Salix Pharmaceuticals' Subcutaneous RELISTOR and Nektar Therapeutics and AstraZeneca's Naloxegol in a meeting being held at FDA Silver Spring, Maryland offices on June 12 at 8 am. Webcast Link
News For AZN;NKTR;SLXP;PGNX From The Last 14 Days
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September 16, 2014
06:27 EDTAZNAstraZeneca, Eli Lilly to jointly develop, commercialize AZD3293
AstraZeneca (AZN) and Eli Lilly (LLY) announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293 has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50M in the 1H15. The companies will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of AZD3293. The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca's 2014 Core Earnings per Share.
September 15, 2014
17:32 EDTSLXPSalix announces tentative FDA approval of UCERIS rectal foam
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15:55 EDTSLXPSalix price target raised to $172 from $163 at Buckingham
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15:41 EDTSLXPSalix calls active on takeover chatter
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07:47 EDTSLXPFDA PDUFA Date for Salix Pharmaceuticals Budesonide is September 15, 2014
07:27 EDTAZNPfizer acquisition could drive shares higher, says JPMorgan
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September 12, 2014
10:32 EDTAZNPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
10:00 EDTSLXPOn The Fly: Analyst Initiation Summary
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08:06 EDTSLXPFollow-up: Salix initiated with an Underperform at Credit Suisse
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06:41 EDTSLXPSalix initiated with an Underperform at Credit Suisse
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September 10, 2014
15:21 EDTAZNAstraZeneca has a conference call hosted by JPMorgan
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September 8, 2014
14:13 EDTAZNConnecticut AG tells FDA to speed up generic Nexium
A news release from the Connecticut Attorney General George Jepsen, dated September 4, says: In comments to a Citizen Petition filed with the FDA, Attorney General George Jepsen called on the federal agency to expeditiously end several years of delays preventing the sale of a generic form of the drug esomeprazole magnesium , esomeprazole, currently marketed under the brand name Nexium. Nexium is the second highest-selling pharmaceutical drug in the United States, and delays in approving generic versions have cost consumers and government healthcare payers billions of dollars. In his comments, Attorney General Jepsen alleges that an agreement between drug manufacturers Ranbaxy (RBXLY) and AstraZeneca Pharmaceuticals (AZN), Nexium’s brand-name manufacturer, has prevented other drug-makers from launching a generic version of the drug, ultimately harming all consumers by artificially inflating prices. Ranbaxy was first-to-file with the FDA for approval of a generic form of Nexium. AstraZeneca sued Ranbaxy for patent infringement, and the dispute was settled by an agreement that provided financial incentives for Ranbaxy to delay entry of its generic into the consumer market. Reference Link
07:21 EDTSLXPJazz looks more attractive for Allergan than Salix, says Wells Fargo
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07:02 EDTAZNAstraZeneca announces availability of Bydureon pen 2mg
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September 5, 2014
15:08 EDTPGNXProgenics, Ono settle claims related to arbitration
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September 4, 2014
17:15 EDTAZNAstraZeneca granted orphan status for EFGR non-small cell lung cancer treatment
The FDA posted on its website that AstraZeneca has been granted orphan status for its treatment of epidermal growth factor receptor, or EFGR, mutation-positive non-small cell lung cancer. Reference Link
07:23 EDTAZNAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
September 3, 2014
05:44 EDTAZNTeva announces positive judgement in patent case against AstraZeneca
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September 2, 2014
07:21 EDTSLXPSalix submits response to FDA's CRL regarding XIFAXAN 550 mg tablets sNDA
Salix Pharmaceuticals announced that on August 29, it submitted its response to the March 7, 2011, FDA Complete Response Letter, or CRL, regarding the Company’s supplemental New Drug Application, or sNDA, for XIFAXAN 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D. Upon receipt of Salix’s response, the FDA will have six months to issue a response.
06:45 EDTAZNAstraZeneca volatility elevated
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