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Stock Market & Financial Investment News

News Breaks
May 1, 2013
10:45 EDTTHRX, THRX, GSK, GSK, VRX, VRX, DEPO, DEPO, FLML, FLML, CELG, CELG, ONXX, ONXX, FRX, FRX, AVEO, AVEOWashington Analysis healthcare analyst holds analyst/industry conference call
Healthcare Analyst Loss discusses top FDA issues which include upcoming FDA meetings, FDA rules and initiatives and PDUFA dates (THRX, GSK, VRX, DEPO, FLML, CELG, ONXX, FRX and AVEO) on an Analyst/Industry conference call to be held on May 1 at 11 am.
News For THRX;GSK;VRX;DEPO;FLML;CELG;ONXX;FRX;AVEO From The Last 14 Days
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September 23, 2014
12:28 EDTVRXSalix climbs after reports say Allergan discussing takeover
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08:53 EDTVRXInversion regulations look more onerous than expected, says FBR Capital
FBR Capital says the new regulations announced last night by the Treasury and IRS contain appear more onerous than expected. FBR points out the proposed changes remove the ability of inverting companies to make "hopscotch loans" between the foreign and domestic subsidiaries. The firm believes the regulations will not end the practice of inversions, and it still expects completion of already announced deals.
08:38 EDTVRXPershing threatens suit against Allergan if no vote held on Salix deal, WSJ says
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08:29 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
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08:07 EDTGSKFDA Pediatric Advisory Committee to hold a meeting
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05:56 EDTVRXTreasury, IRS announce plans to reduce inversion tax benefits
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September 22, 2014
19:03 EDTVRXAllergan rejected buyout bid from Actavis, in advanced talks for Salix, WSJ says
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10:15 EDTGSKOn The Fly: Analyst Upgrade Summary
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07:21 EDTGSK, CELGEBD Group to hold a conference
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05:27 EDTGSKGlaxoSmithKline upgraded to Buy from Neutral at Goldman
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September 19, 2014
11:25 EDTVRXSenators bring bill requiring companies to settle before inverting
U.S. Senators Sherrod Brown and Dick Durbin announced new legislation requiring corporations to "Pay What You Owe Before You Go" – settling their U.S. tax bill before relocating to a foreign country. "Everyone knows that before you leave a restaurant you have to settle your tab," Brown said. "Corporations shouldn’t get to play by different rules. While it is critical that we reach a long-term solution that reforms our international corporate tax code by implementing a global minimum tax and reducing the statutory tax rate, this bill is an immediate, commonsense measure to ensure businesses settle up before leaving the U.S." Among the deals or possible transactions that involve inversion are Mylan's (MYL) acquisition of Abbott (ABT), Medtronic's (MDT) acquisition of Covidien (COV) and Valeant's (VRX) proposed takeover of Allergan (AGN).
05:58 EDTGSKGlaxoSmithKline to pay GBP 297M fine to Chinese government
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September 17, 2014
16:18 EDTDEPODepomed 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.
14:57 EDTGSKProsensa announces commencement of re-dosing of drisapersen
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07:39 EDTGSKMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
07:00 EDTCELGConcert Pharmaceuticals announces initiation of CTP-730 Phase 1 trial
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September 16, 2014
11:51 EDTVRXOECD looks to close tax loopholes with new proposals
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07:33 EDTGSKMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTGSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
05:37 EDTVRXValeant, Pershing Square, Allergan settle pending litigation before DE Court
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