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Stock Market & Financial Investment News

News Breaks
June 19, 2014
08:36 EDTACT, NVSDistrict court rules against Actavis' generic version of Novartis' Exelon
Actavis (ACT) confirmed that the U.S. District Court for the District of Delaware has found certain claims of two U.S. patents valid and infringed by Actavis' generic version of Novartis' (NVS) Exelon Patch. Actavis is reviewing the court's decision and will evaluate all available options, including an appeal. Exelon Patch is a prescription medicine used to treat people with mild to moderate dementia associated with Alzheimer's or Parkinson's disease. Actavis' Abbreviated New Drug Application for its generic version of Exelon Patch is currently pending with the FDA.
News For ACT;NVS From The Last 14 Days
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September 22, 2014
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 EDTNVSEuropean 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 EDTNVSIBC Life Sciences to hold a conference
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07:27 EDTACTPfizer acquisition could drive shares higher, says JPMorgan
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07:21 EDTNVSHeart Failure Society of America to hold annual meeting
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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
05:18 EDTNVSNovartis announces new data confirms high efficacy of Gilenya in achieving NEDA
Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya in achieving 'no evidence of disease activity', or NEDA, in people with relapsing-remitting multiple sclerosis, or RRMS, across four key disease measures - relapses, MRI lesions, brain shrinkage and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures. NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
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.
05:17 EDTNVSNovartis Gilenya data confirms reducing brain shrinkage matter for MS patients
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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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07:55 EDTNVSOphthotech earlier than expected Novartis payment positive, says Oppenheimer
After Ophthotech (OPHT) received a $50M Phase 3 enrollment payment from Novartis (NVS) earlier than expected, Oppenheimer thinks the payment highlights an underappreciated stock driver for Opthotech, and demonstrates that recent suggestions of Phase 3 enrollment timelines possibly slipping are unwarranted. The firm believes the company is executing well on the Fovista Phase 3 program and keeps an Outperform rating on the stock.
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