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Stock Market & Financial Investment News

News Breaks
June 25, 2014
05:32 EDTSHPG, ACT, MYL, NVSShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
News For SHPG;ACT;MYL;NVS From The Last 14 Days
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September 16, 2014
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
10:55 EDTSHPGRegulators to determine AbbVie, Shire deal by next month, Reuters says
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08:01 EDTSHPGShire announces FDA acceptance for filing of sNDA for Vyvanse
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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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06:34 EDTMYLMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
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.
08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.
07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
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.
06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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