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Stock Market & Financial Investment News

News Breaks
August 21, 2014
07:47 EDTPFE, ACT, AZNPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
News For PFE;ACT;AZN From The Last 14 Days
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September 19, 2014
16:00 EDTPFEOptions Update; September 19, 2014
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14:18 EDTACTAkorn competition settlement over VersaPharm deal approved by FTC
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10:07 EDTPFEHigh option volume stocks
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09:33 EDTAZNAstraZeneca says DURATION-NEO-1 trial met primary endpoint
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07:54 EDTAZNSalix price target raised to $192 from $161 at Canaccord
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September 17, 2014
16:18 EDTACTDepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
11:01 EDTACTActavis drops after NY AG seeks to block Alzheimer drug switch
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09:16 EDTACTActavis Namenda sales of $990M could be at risk, says BMO Capital
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09:06 EDTACTNew York AG files antitrust lawsuit against Actavis
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07:43 EDTAZN, PFEBofA/Merrill to hold a conference
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September 16, 2014
14:33 EDTAZNNektar price target raised to $20 from $18 at Brean Capital
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12:37 EDTAZNNektar reports FDA approval of MOVANTIK for treatment of OIC
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the FDA approved MOVANTIK tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic, non-cancer pain. In line with the recommendation from the FDA Anesthetic and Analgesic Drug Products Advisory Committee that took place in June, AstraZeneca has agreed to conduct a post-marketing, observational epidemiologic cardiovascular safety study for MOVANTIK. MOVANTIK is expected to be available to patients in the first half of 2015. MOVANTIK is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the New Drug Application, the FDA evaluated the abuse potential of MOVANTIK and the approved labelling indicates that MOVANTIK has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of MOVANTIK to the U.S. Drug Enforcement Administration, or DEA, in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request.
11:51 EDTAZN, PFE, ACTOECD looks to close tax loopholes with new proposals
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10:19 EDTAZNFDA approves Movantik with requirement for cardiovascular risk study
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08:00 EDTAZNFDA PDUFA Date for Nektar and AstraZeneca''s Movantik is September 16, 2014
07:31 EDTAZNEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:19 EDTPFECompanies' share buybacks at fasttest clip since 2007, WSJ reports
Companies are buying back their own shares at its fastest pace since the financial crisis to fuel a stock rally, reports the Wall Street Journal. According to Birinyi Associates, companies have bought back $338.3B of stock in 1H14, the most since 2007. Citing an analysis by Barclays, companies with the largest buyback programs by dollar value have outperformed the broader market by 20% since 2008. Reference Link
07:02 EDTAZNEli Lilly and AstraZeneca to co-develop and commercialize AZD3293
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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.
06:06 EDTACTActavis, subsidiary sued by NY attorney general, Reuters says
New York attorney general Eric Schneiderman filed a lawsuit versus Actavis and its subsidiary, Forest Laboratories, to impede the firms from stopping its Alzheimer's medication production, claiming that they were aiming to illegally maintain a monopolistic stance, according to Reuters, citing comments from Schneiderman. Reference Link
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