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News Breaks
January 31, 2014
05:08 EDTMYL, GILDMylan named as Gilead exclusive branded medicines partner for India
Mylan (MYL) announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences (GILD) exclusive branded medicines business partner for India. Under the agreement, Mylan will market and distribute in India Gilead's: HIV therapies Viread, Truvada, and the newer single tablet regimen Stribild. AmBisome, a treatment for life-threatening, systemic fungal infections, which is also used to treat the parasitic disease visceral leishmaniasis. Viread for its indication as a treatment for chronic hepatitis B virus infection. Gilead has partnered with Mylan since 2006, granting the company rights to manufacture and sell their own generic versions of licensed Gilead HIV therapies in India and up to 111 developing world countries where the HIV epidemic affects millions of individuals. Mylan will continue to maintain these rights, in addition to those in this new agreement.
News For MYL;GILD From The Last 14 Days
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August 28, 2015
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 EDTGILDGilead 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
19:34 EDTGILDExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
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
13:36 EDTGILDBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
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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August 20, 2015
16:34 EDTGILDGilead MAA for HIV regimen has been fully validated by EMA
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
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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