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News Breaks
December 27, 2012
08:21 EDTRHHBY, OREX, ARNA, GSK, VVUSU.S. market gets wave of new weight loss drugs, FT reports
The U.S. market has had only one prescription weight loss drug for several years, Roche’s (RHHBY) Xenical, which is also sold over-the-counter by GlaxoSmithKline (GSK) as Alli, but that drug has recently been joined by Vivus' (VVUS) Qsymia and Arena (ARNA) is set to launch Belviq shortly, reported Financial Times. Orexigen (OREX) is also preparing to re-submit its Contrave weight loss drug for a new regulatory review. The report on the resurgence of weight loss drug development noted that Vivus' CEO foresees the potential for using direct-to-consumer advertising and a larger scale sales force to market Qsymia, which would likely require a big pharma partner. Reference Link
News For VVUS;ARNA;OREX;GSK;RHHBY From The Last 14 Days
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 22, 2015
07:37 EDTOREXOrexigen and Takeda receive Paragraph IV certification notice
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05:27 EDTRHHBYRoche sees FY15 core EPS to grow ahead of sales at constant exchange rates
Expects FY15 sales to grow low- to mid-single digit, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:27 EDTRHHBYRoche reports Q1 group sales CHF 11.83B vs. CHF 11.50B
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April 21, 2015
16:32 EDTVVUSVIVUS granted patents covering Qsymia compositions and methods
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14:02 EDTOREXParagraph IV patent challenges submitted to FDA for Orexigen's Contrave
An Abbreviated New Drug Application, or ANDA, has been received by the Office of Generic Drugs containing a "Paragraph IV" patent certification for Contrave, the weight loss drug whose patent is owned by Orexigen Therapeutics, according to an FDA notice. The date on which the first substantially complete generic drug application was submitted to the Agency for Contrave was March 12, according to the posting. Reference Link
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. Bina’s 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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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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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
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
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.

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