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Stock Market & Financial Investment News

News Breaks
November 21, 2012
10:20 EDTGSK, AET, VVUS, PFE, OREX, RHHBY, ARNAVIVUS rallies after Aetna revises obesity drug policy
In a Clinical Policy Bulletin revision dated November 20, 2012, Aetna (AET) specified criteria under which the insurer considers weight reduction medications as "medically necessary" for treatment of obesity. Aetna stated, "For members whose medical policies do not exclude weight reduction medications or services and supplies for or related to weight reduction programs, Aetna covers [the following] drugs under the medical benefit, not the pharmacy benefit." Among the medications that have been approved by the FDA for weight reduction which would be covered under its policy, Aetna listed Qsymia, marketed by VIVUS (VVUS), Belviq from Arena Pharmaceuticals (ARNA), Didrex from Pfizer's (PFE) Pharmacia unit, Roche's (RHHBY) Xenical, and GlaxoSmithKline's (GSK) Alli. Early session strength in shares of VIVUS and Arena has been attributed to Aetna's policy revision, and shares of Orexigen Therapeutics (OREX), which is developing a weight loss treatment that is being considered by the FDA for approval, have also moved higher. In early morning trading, VIVUS advanced $1.58, or 15.27%, to $11.93, Arena gained 20c, or 2.24%, to $9.13 and Orexigen added 30c, or 6.88%, to $4.66.
News For VVUS;ARNA;OREX;AET;RHHBY;PFE;GSK From The Last 14 Days
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March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
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15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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11:00 EDTPFEPfizer participates in a conference call with Bernstein
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10:02 EDTAETOn The Fly: Analyst Upgrade Summary
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08:20 EDTAETAetna upgraded at Sterne Agee
As noted earlier, Sterne Agee upgraded Aetna to Buy from Neutral. The firm says that the company is the best-positioned name within the large-cap health plan space , a defensive sector that has little exposure to Europe and reasonable growth prospects, according to the firm.
07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREOŽ ELLIPTAŽ), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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06:19 EDTAETAetna upgraded to Buy from Neutral at Sterne Agee
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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12:48 EDTRHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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12:46 EDTAETAetna, HackensackAlliance ACO announce collaboration
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
09:00 EDTAETAetna management to meet with JPMorgan
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08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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March 16, 2015
07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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