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Stock Market & Financial Investment News

News Breaks
April 15, 2014
08:06 EDTGSK, MYLProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
Prosonix announced that it has entered into a global licensing agreement with Mylan (MYL) for its leading inhaled respiratory products, PSX1001 and PSX1050. PSX1001 and PSX1050 are being developed as generic versions to GlaxoSmithKline's (GSK) pressurised metered dose inhalers Flixotide and Flovent, respectively. According to IMS Health, Flixotide and Flovent had global brand sales of approximately $1.3B for the 12 months ending Dec. 31, 2013. A first marketing authorisation application for PSX1001 is expected to be submitted in the European Union in 2014.
News For MYL;GSK From The Last 14 Days
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September 4, 2015
09:20 EDTGSKARIAD drawing interest from companies besides Baxalta, dealReporter says
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September 2, 2015
12:46 EDTGSKGlaxoSmithKline reports 24.5% passive stake in Theravance Biopharma
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08:08 EDTMYLMylan confirms USPTO institutes IPR proceeding against third Copaxone patent
Mylan announced that the U.S. Patent and Trademark Office has instituted an inter partes review proceeding on all claims against a third Copaxone 40 mg/mL patent, U.S. Patent No. 8,969,302, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. The patent relates to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg/mL subcutaneous injections of glatiramer acetate per week. On Aug. 25, 2015, Mylan announced that the PTO instituted IPR proceedings against two related Copaxone(R) 40 mg/mL patents, U.S. Patent Nos. 8,232,250 and 8,399,413, on all claims. The oral hearing for all three IPRs has been scheduled for May 12, 2016.
September 1, 2015
07:34 EDTGSKAdaptimmune expands trial of T-cell therapy for synovial sarcoma
Adaptimmune Therapeutics (ADAP) announced that the first patient has been dosed in its expanded Phase I/II trial of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in synovial sarcoma patients. Based on encouraging results in the first cohort of 10 patients, presented at the American Association for Cancer Research annual meeting in April 2015, the trial is being expanded to encompass an additional 20 patients in two further cohorts. The expansion of Adaptimmune's trial also triggers two milestone payments from GlaxoSmithKline (GSK). Adaptimmune is collaborating with GSK for the development of its NY-ESO TCR program through a strategic cancer immunotherapy partnership announced in June 2014. Under the terms of the agreement, GSK has an exclusive option to license Adaptimmune's NY-ESO TCR therapeutic and upon exercise would assume full responsibility for further development and commercialization of the therapeutic. Adaptimmune's clinical study includes synovial sarcoma patients who have received standard first line therapy containing ifosfamide and/or doxorubicin and who are intolerant or no longer responding to the regimen, and whose tumor expresses a tumor antigen known as NY-ESO-1. The NY-ESO-1 antigen is believed to be present in 60 to 70 percent of synovial sarcoma patients.The primary objectives of the study are to determine the safety of adoptively transferred autologous T cells expressing an affinity enhanced T cell receptor that recognizes the NY-ESO-1 antigen in HLA-A*0201, HLA-A*0205, and/or HLA-A*0206 positive patients with unresectable, metastatic or recurrent synovial sarcoma. Secondary objectives include the determination of efficacy through response rate and duration of response.
August 31, 2015
06:51 EDTMYLDutch pension fund sells Mylan shares over death penalty drug, Reuters says
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August 28, 2015
16:17 EDTMYLOn The Fly: Top stock stories for Friday
Stocks slipped at the open as the futures once again were influenced by the volatile overnight trading session in China. The averages began to recover shortly after the open and turned mixed by midday. Comments from Fed Vice Chairman Stanley Fisher about the central bank being open to a possible rate hike in September took some momentum out of the market. As the volume slowed and the news flow went silent, the volatility increased and the averages headed lower only to rebound before the close, but the trading was still remarkably calm when compared to the wide swings seen in the market in the earlier sessions of this week. ECONOMIC EVENTS: In the U.S., personal income rose 0.4% in July, as expected, with consumer spending up 0.3%, which was below the 0.4% consensus growth forecast. The University of Michigan consumer sentiment reading for August was revised down to 91.9 from the 92.9 preliminary reading, versus expectations for it to be bumped up to 93.0. Baker Hughes reported the U.S. rig count is down 8 rigs from last week to 877. WTI crude oil prices added another 6% today to yesterday's 10% rally, closing at $45.22 a barrel on Friday. U.S. crude closed with a weekly gain of 11.8%, marking its first advance in 10 weeks and best week in six years. The Federal Reserve may still raise its benchmark interest rate in September, Fed vice chairman Stanley Fischer said in an interview with CNBC, noting that Fed committee members "haven't made a decision yet" and have "time to wait and see," because the next policy-making meeting won't happen until the middle of next month. COMPANY NEWS: Shares of cancer drug maker ARIAD (ARIA) surged $2.91, or 41.69%, to $9.89 after Bloomberg reported that industry peer Baxalta (BXLT) is in takeover talks with the smaller company to boost its oncology pipeline. Baxalta, which had recently turned down a merger offer from Shire (SHPG), fell $1.18, or 3.24%, to $35.25 following the report... In other pharmaceutical industry M&A news, Mylan (MYL) shareholders voted to approve the company's proposed acquisition of Perrigo (PRGO) and the related issuance of Mylan ordinary shares. Afterward, Perrigo CEO Joseph Papa said he was confident that most of his company's shareholders believe that Mylan's offer substantially undervalues Perrigo and would dilute its "growth profile and superior valuation"... Video game maker Activision Blizzard (ATVI) and airline owner United Continental (UAL) both advanced sharply, rising 4.62% and 6.93%, respectively, after each had their shares selected to join the S&P 500. Activision will replace Pall Corp. (PLL) in the S&P 500 after the close of trading tonight, while United will replace Hospira (HSP) in the index after the close of trading on Wednesday, September 2. MAJOR MOVERS: Among the notable gainers was Big Lots (BIG), which advanced $6.58, or 15.67%, to $48.58 after the discount retailer reported better than expected quarterly results and lifted its fiscal year guidance. Among the noteworthy losers after their quarterly reports were video game retailer GameStop (GME), which slid $3.71, or 8.03%, to $42.49, and design software and services company Autodesk (ADSK), which fell $2.48, or 4.96%, to $47.52. INDEXES: The Dow fell 11.76, or 0.07%, to 16,643.01, the Nasdaq gained 15.62, or 0.32%, to 4,828.33, and the S&P 500 advanced 1.21, or 0.06%, to 1,988.87.
09:31 EDTMYLMylan vote not surprising, Perrigo likely to rise in near-term, says BMO Capital
BMO Capital analyst David Maris believes that Mylan (MYL) shareholders' vote in favor of Mylan's proposed takeover of Perrigo (PRGO) and authorizing the company to issue shares was the outcome expected by most investors and will not come as a surprise to the market. Maris noted that he expects Perrigo shares will rise in the coming days amid speculation on its next move and thinks the Mylan bid significantly undervalues the company, which he estimates is worth $246 per share on a stand-alone basis. The firm keeps an Outperform rating on Perrigo and a Market Perform rating on Mylan.
08:06 EDTMYLPerrigo 'confident' shareholders will reject Mylan 's offer
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07:22 EDTMYLMylan shareholders approve proposed acquisition of Perrigo
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August 26, 2015
17:06 EDTGSKGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
10:07 EDTMYLMylan initiated with a Buy at Standpoint Research
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06:55 EDTMYLMylan shares may sell off on affirmative Perrigo deal vote, says BMO Capital
With Mylan (MYL) set to hold a shareholder vote on August 28 regarding its proposed acquisition of Perrigo (PRGO), BMO Capital analyst David Maris predicts that if the vote goes in Mylan's favor, he expects Perrigo shares to rise and Mylan shares to fall. Afterward, he feels added overhangs, such as Teva's (TEVA) and Abbott's (ABT) shareholdings and potential short-term selling by arbitrageurs, will come into play, further pressuring Mylan shares.
05:58 EDTMYLPerrigo CEO says company is 'very active in M&A,' Bloomberg reports
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August 25, 2015
15:02 EDTMYLMylan says USPTO institutes IPR of two Copaxone patents
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14:40 EDTMYLTeva Copaxone patents to be reconsidered by regulators, Bloomberg says
14:16 EDTMYLMylan launches generic version of Pfizer's Zosyn Injection
Mylan (MYL) announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer's (PFE) Zosyn Injection. This product is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria. Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials had U.S. sales of approximately $72.1M for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.
13:22 EDTMYLMylan comments on 'misleading' Perrigo statements
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11:27 EDTMYLTeva to refrain from voting at Mylan special meeting
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August 24, 2015
13:15 EDTGSKFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

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