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Stock Market & Financial Investment News

News Breaks
February 28, 2014
16:13 EDTACT, TKPYYActavis confirms patent challenge on generic Colcrys
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the U.S. FDA seeking approval to market Colchicine Tablets USP, 0.6 mg. Actavis' ANDA product is a generic version of Takeda's (TKPYY) Colcrys, which is a prescription medicine used in adults to prevent and treat gout flares. Takeda Pharmaceuticals U.S.A. filed suit against Actavis on February 27 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
News For ACT;TKPYY From The Last 14 Days
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September 22, 2014
19:03 EDTACTAllergan rejected buyout bid from Actavis, in advanced talks for Salix, WSJ says
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10:15 EDTACTOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Actavis (ACT) downgraded to Equal Weight from Overweight at Barclays... Aetna (AET) downgraded to Neutral from Buy at BofA/Merrill... Auxilium (AUXL) downgraded to Hold from Buy at Stifel... CARBO Ceramics (CRR) downgraded to Neutral from Buy at Sterne Agee... Commerzbank (CRZBY) downgraded to Underperform from Neutral at Exane BNP Paribas... Concur (CNQR) downgraded to Neutral from Buy at Nomura... Dresser-Rand (DRC) downgraded to Neutral from Accumulate at Global Hunter... Finish Line (FINL) downgraded to Equal Weight from Overweight at Morgan Stanley... General Communications (GNCMA) downgraded to Hold from Buy at Drexel Hamilton... InvenSense (INVN) downgraded to Neutral from Outperform at RW Baird... Las Vegas Sands (LVS) downgraded to Market Perform from Outperform at Wells Fargo... Lindsay Corp. (LNN) downgraded at Sterne Agee... Melco Crown (MPEL) downgraded to Market Perform from Outperform at Wells Fargo... Outerwall (OUTR) downgraded to Sell from Neutral at B. Riley... PSEG (PEG) downgraded to Hold from Buy at Jefferies... Realogy (RLGY) downgraded to Underperform from Neutral at Credit Suisse... Regal-Beloit (RBC) downgraded to Accumulate from Buy at Global Hunter... SABMiller (SBMRY) downgraded to Market Perform from Outperform at Bernstein... Saba Software (SABA) downgraded to Neutral from Buy at B. Riley... Suburban Propane (SPH) downgraded to Market Perform from Outperform at Wells Fargo... Swiss Re (SSREY) downgraded to Underperform from Neutral at Exane BNP Paribas... Towers Watson (TW) downgraded to Buy from Conviction Buy at Goldman... Valmont (VMI) downgraded at Sterne Agee... Walgreen (WAG) downgraded to Equal Weight from Overweight at Barclays... Watts Water (WTS) downgraded to Neutral from Buy at Janney Capital... Wynn Resorts (WYNN) downgraded to Market Perform from Outperform at Wells Fargo... Yahoo (YHOO) downgraded to Neutral from Buy at BofA/Merrill.
08:10 EDTACTActavis multiple expansion case 'compelling,' says JPMorgan
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05:52 EDTACTActavis downgraded to Equal Weight from Overweight at Barclays
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September 19, 2014
14:18 EDTACTAkorn competition settlement over VersaPharm deal approved by FTC
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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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September 16, 2014
11:51 EDTACTOECD looks to close tax loopholes with new proposals
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07:31 EDTTKPYYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
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
September 15, 2014
07:27 EDTACTPfizer acquisition could drive shares higher, says JPMorgan
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September 12, 2014
10:32 EDTACTPfizer 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
September 11, 2014
06:49 EDTTKPYYFDA approves weight management drug Contrave
The U.S. Food and Drug Administration yesterday approved Contrave as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. Contrave is distributed by Takeda Pharmaceuticals America (TKPYY) for Orexigen Therapeutics (OREX).
September 10, 2014
09:02 EDTACTActavis won't see serious long-term impact from rejection, says Sterne Agee
After the FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension, Sterne Agee does not thinks the vote is very meaningful to the company's longer-term growth and earnings potential. The firm says that removing the product from its revenue outlook causes its 2018 EPS estimate for the company to drop by less than 1%. The firm still thinks the company can easily reach its 2017 EPS target of about $20. Sterne Agee keeps a $272 price target and Buy rating on the shares.
08:56 EDTACTFDA advisors recommend against approval of Actavis' nebivolol/valsartan combo
Actavis last night confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval. The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014. Actavis' Senior VP, Global Brands Research and Development, David Nicholson, said, "Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension. We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review." Shares of Actavis are down more than 2% in pre-market trading following yesterday's committee recommendation.
September 9, 2014
17:06 EDTACTFDA panel votes against Actavis blood pressure pill, Bloomberg says
FDA advisers said that Actavis's experimental pill that combines two existing drugs to lower high blood pressure doesn’t provide a clinically meaningful benefit over the two drugs alone, says Bloomberg. The advisory panel voted 6 to 4 against recommending the treatment, added Bloomberg. Shares of Actavis are trading down almost 1% in after-hours trading. Reference Link
10:18 EDTACTDollar General listed among 5 largest long positions by Jana Partners
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September 8, 2014
17:22 EDTTKPYYOrexigen, Takeda Pharmaceutical in services agreement
Orexigen disclosed in a regulatory filing that in preparation for the potential launch of NB32, Orexigen Therapeutics (OREX) and Takeda Pharmaceutical Company (TKPYY) entered into a Manufacturing Services Agreement, dated September 2, in accordance with the Collaboration Agreement between the company and Takeda, effective as of September 1, 2010, as amended by Amendment Number 1 to Collaboration Agreement effective as of September 26, 2013. Pursuant to the Agreement, among other things, the company will supply to Takeda, and Takeda will, subject to certain exceptions as set forth in the Agreement and Collaboration Agreement, exclusively purchase from the Company, all of Takeda’s requirements of NB32 for commercialization in the United States, Canada and Mexico during the term of the Collaboration Agreement. The Agreement will continue in full force and effect until the expiration or termination of the Collaboration Agreement.

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