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News Breaks
July 17, 2014
07:18 EDTMYL, GSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
Mylan's (MYL) motion for a permanent injunction against GlaxoSmithKline (GSK) in relation to Paroxetine CR, the generic version of GSK's Paxil CR, has been granted by the U.S. District Court for the District of New Jersey. GSK is now precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan had previously been awarded damages in the amount of $106.7M by the District Court after a favorable jury verdict in March. In addition, the District Court awarded Mylan prejudgment interest and permitted it to take an accounting so that Mylan can determine the amount of additional damages it has suffered since Sept. 30, 2013 as a result of GSK's ongoing breach. All of GSK's post-trial motions were denied.
News For MYL;GSK From The Last 14 Days
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August 28, 2015
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.
August 21, 2015
15:22 EDTMYLMylan clarifies certain inaccuracies related to lowered condition to acquire Perrigo
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08:19 EDTMYLMylan to host special shareholder meeting
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05:25 EDTGSKNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 18, 2015
11:34 EDTMYLMylan says FDA warning on Agila facilities has no material impact on forecast
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10:19 EDTMYLMylan calls active on speculation of an activist investor stake
Mylan August 55 and 60 calls are active on total call volume of 7,900 contracts (800 puts) on speculation of an activist investor stake. August call option implied volatility is at 42, September is at 38; compared to its 52-week range of 22 to 52. Active call volume suggests traders taking positions for upside price movement.
10:01 EDTMYLRumor: Mylan moves higher on speculation of an activist investor stake
07:32 EDTMYLMylan sued in connection with filing of ANDA for Abiraterone Acetate Tablets
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