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News Breaks
April 28, 2014
07:27 EDTPFE, LLY, SNY, NVS, GSKDrug companies targeting myostatin, WSJ reports
Drug companies, including Novartis (NVS), Eli Lilly (LLY), Sanofi (SNY), Pfizer (PFE) and Glaxosmithkline (GSK), are looking make a drug that targets myostatin, a naturally occurring protein that curbs muscle growth, the Wall Street Journal reports. All the companies' drugs are in clinical or earlier-stage testing, and the first drug could be approved in 2016. Reference Link
News For NVS;LLY;GSK;SNY;PFE From The Last 14 Days
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August 28, 2015
08:01 EDTSNYAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 27, 2015
19:14 EDTSNYExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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17:38 EDTPFES&P announces changes to S&P 500 index
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10:32 EDTLLYFDA approvals Synjardy tablets for adults with Type 2 diabetes
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07:24 EDTPFEPfizer shares even more compelling after recent weakness, says Piper Jaffray
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06:55 EDTPFEHospira sees merger closing on or about September 3
Hospira (HSP) said in a regulatory filing that on August 21, Hospira and Pfizer (PFE) received clearance from the U.S. FTC, relating to the pending merger of Hospira with Perkins Holding Company, a wholly-owned subsidiary of Pfizer. All required regulatory approvals have now been secured, though the merger remains conditioned upon the expiration of a post-clearance waiting period in one foreign jurisdiction. Hospira expects the merger to close on or about September 3.
05:20 EDTLLYEli Lilly, Adocia initiate new Phase 1b study of BioChaperone Lispro
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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.
07:32 EDTPFEPfizer launches Phase 3 trial of targeted therapy for breast cancer patients
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06:16 EDTPFEAlvogen to acquire product portfolio from Pfizer for US market
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August 25, 2015
17:11 EDTLLYU.S. District Court rules in Eli Lilly's favor on Alimta vitamin regimen patent
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15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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14:16 EDTPFEMylan 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.
August 24, 2015
13:15 EDTNVS, GSKFDA 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.
12:57 EDTPFEFTC requires Pfizer to sell rights to four products as condition of buying Hospira
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12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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08:16 EDTPFEBristol-Myers, Pfizer to present new data on Eliquis at ESC Congress 2015
Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) announced that 22 abstracts will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance's commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation and venous thromboembolism patient populations. In addition, data from the AEGEAN study evaluating adherence among NVAF patients further extends the Alliance's commitment to patient care.
08:01 EDTPFEPfizer receives clearance from FTC for Hospira acquisition
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August 23, 2015
12:35 EDTPFEBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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