Novartis treatment of adenoid cystic carcinoma granted FDA orphan designation

by | Sep 28, 2013 | COPD in the News | 0 comments

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September 27, 2013
17:06 EDT NVS Novartis treatment of adenoid cystic carcinoma granted FDA orphan designation
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News For NVS From The Last 14 Days

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September 27, 2013
17:06 EDT NVS Novartis treatment of adenoid cystic carcinoma granted FDA orphan designation
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05:44 EDT NVS Novartis reports new data for Lucentis backs transformational efficacy
New clinical and real world data for Lucentis confirm its transformational and well-established safety profile in four retinal diseases. Designed for intraocular use, Lucentis is an antibody fragment with a short systemic half-life and was first launched in Europe in 2007. Lucentis is now indicated in many countries for the treatment of wet age-related macular degeneration, or wet AMD, for visual impairment due to diabetic macular edema, macular edema secondary to branch- and central-retinal vein occlusion, and choroidal neovascularization secondary to pathologic myopia.
September 25, 2013
07:22 EDT NVS The FDA and DIA to co-host a conference
Oligonucleotide-Based Therapeutics Conference is being held in Washington, D.C. on September 25-27.
05:28 EDT NVS Novartis presents data confirming Gilenya long-term efficacy
New data showing the benefits of Gilenya on patient outcomes in multiple sclerosis, or MS, will be presented at the 29 Congress of the European Committee for Research and Treatment in Multiple Sclerosis, or ECTRIMS, in Copenhagen, Denmark, adding to the growing evidence base for Gilenya in both clinical trial and real-world settings. New four-year data from the pivotal FREEDOMS and FREEDOMS extension studies plus a separate analysis of three studies will show the benefits of continued Gilenya treatment on brain volume loss compared to delayed treatment of two years. These data will reinforce what we know about the correlation between brain volume loss and disability, underlining the need for effectively addressing brain volume loss in patients with MS. Data from international and U.S. real-world databases will also confirm the favorable effect of Gilenya on reducing relapse rates for patients with MS.
September 23, 2013
11:14 EDT NVS BioScrip discloses government plans to discuss civil investigation
BioScrip disclosed earlier that on September 11 the company was advised by the government that it plans to engage in discussions with the company regarding a civil investigation. As previously disclosed, the company sold its traditional and specialty pharmacy mail operations and community retail pharmacy stores on May 4, 2012. Pursuant to a civil investigative demand issued by the United States Attorney’s Office for the Southern District of New York and a subpoena from the New York State Attorney General’s Medicaid Fraud Control Unit, the company has cooperated by producing documents and information regarding the distribution of the Novartis Pharmaceuticals’ (NVS) product Exjade by the company’s legacy specialty pharmacy division that was divested. BioScrip stated: “To the company’s knowledge, no proceedings have been initiated against it at this time. The company cannot predict or determine the timing or outcome of this investigation or the impact it may have, if any, on the company’s financial condition, results of operations or cash flows.”
05:33 EDT NVS Novartis’ Ultibro Breezhaler approved in EU, Japan
Novartis announced that the European Commission approved once-daily Ultibro Breezhaler as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease, or COPD. In addition, the Japanese Ministry of Health, Labour and Welfare approved once-daily Ultibro Inhalation Capsules, delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease.
September 19, 2013
10:19 EDT NVS Novartis granted orphan status for Cushing’s treatment
The FDA posted on its website that it granted Novartis orphan status for its treatment of Cushing’s disease.
September 17, 2013
14:26 EDT NVS Novartis unit probes allegations of bribery in China, WSJ says
Novartis’ eye-care unit Alcon has initiated an investigation into allegations that some its staff bribed doctors at hospitals in China, reports The Wall Street Journal. Reference Link
07:31 EDT NVS Novartis’s Alcon faces Chinese corruption allegations, FT reports
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September 16, 2013
10:04 EDT NVS On The Fly: Analyst Downgrade Summary
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07:46 EDT NVS IBC Life Sciences to host a conference
BioProcess International Conference is being held in Boston on September 16-19.
07:27 EDT NVS Parental Drug Association / FDA to host a conference
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05:37 EDT NVS Novartis downgraded to Underweight from Equal Weight at Barclays

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