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News Breaks
November 21, 2012
10:20 EDTRHHBY, ARNA, GSK, AET, VVUS, PFE, OREXVIVUS 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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April 21, 2015
07:06 EDTRHHBYBina Tech, AstraZeneca announce collaborative agreement for GMS
Bina Technologies, a member of the Roche Group (RHHBY), and AstraZeneca (AZN) announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Program and to further develop the Bina Genomic Management Solution. AstraZeneca will utilize the Bina GMS as an enterprise platform to support its development work across three main therapeutic areas: oncology, cardiovascular and metabolic disease, and respiratory, inflammation and autoimmunity. Binas proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximize the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support enterprise genomic data analysis and management. Bina in turn will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.
05:33 EDTRHHBYInovio, Roche initiate clinical trial for DNA immunotherapy to treat HCB
Inovio Pharmaceuticals (INO) announced that it has initiated a Phase I trial to evaluate Inovio's DNA immunotherapy in patients who are chronically infected with hepatitis B. In 2013, Roche (RHHBY) and Inovio entered into a partnership to co-develop and commercialize Inovio's hepatitis B immunotherapy. This trial initiation triggers a $3M milestone payment from Roche to Inovio. This phase I, randomized, open-label, active-controlled, dose escalation study will evaluate the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator. This international study will enroll patients in the United States and Asia Pacific region with a primary endpoint of safety and tolerability of the therapy. The secondary endpoints will evaluate the cellular and humoral immune response to INO-1800 and investigate the therapy's effect on several viral and antiviral parameters. All trial subjects are also medicated with standard-of-care antiviral therapies.
April 20, 2015
10:03 EDTVVUSHigh option volume stocks
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08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 17, 2015
05:32 EDTRHHBYAccelerate Diagnostics appoints Pete Bantock to Chief Culture Officer
Accelerate Diagnostics (AXDX) appointed Pete Bantock to the newly created position of Chief Culture Officer and Head of Human Resources. Bantock was most recently the SVP and Head of commercial Operations for the Americas. He will be replaced by Ron Price, who joins the company from Roche (RHHBY) where he held the position of VP of Point of Care and Commercial Operations.
April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
08:04 EDTRHHBYRoche granted orphan status for lymphoma treatment
The FDA granted Roche's Genentech unit orphan status for Gazyva, its treatment of follicular lymphoma.
April 15, 2015
19:34 EDTVVUSVIVUS files patent infringement lawsuit against Teva
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11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 14, 2015
07:10 EDTVVUSVIVUS says CVOT 'unlikely to initiate' in 2015
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06:30 EDTRHHBYRoche to seek to have cancer drug tested in 11 trials in 2015, Reuters says
Roche said it would seek to have its immunotherapy cancer drug, MPDL3280A, in 11 late stage trials by the end of 2015, aaccording to Reuters. The drug is being tested in melanoma, as well as lung, bladder, kidney, bowel and blood cancers, the news service noted. Reference Link
April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
10:58 EDTAETCigna, Humana seen as potential takeover targets in Managed Care space
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10:01 EDTRHHBYRoche acquires CAPP Medical
Roche announced it has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and industry veterans, to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA in blood.
07:33 EDTAETJefferies sees low probability of WellCare, Centene buyouts
After running several acquisition scenarios for the Managed Care space, Jefferies says potential takeovers of WellCare (WCG) and Centene (CNC) are "hard to justify." The firm estimates acquirers will only be able to generate 1%-3% accretion from buying either company at a 20% premium to current share prices. The deal that makes the most financial sense is Aetna (AET) buying Cigna (CI), Jefferies says today in a note to investors. Also financially attractive would be a buyout of Humana (HUM) by either Anthem (ANTM) or Aetna, the firm adds. After analyzing the Managed Care space, it upgraded this morning shares of UnitedHealth (UNH) to Buy from Hold with a $141 price target. Jefferies also has Buy ratings on Aetna, Anthem, Health Net (HNT) and Molina Healthcare (MOH).
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