Market Applicability

 
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The Company and its co-development partner, IntelGenx Corp., held a Scientific Advice meeting with the German pharmaceuticals regulation authority (BfArM) and plan to submit a Marketing Authorization Application (MAA) to market RHB-103 in Europe during the first half of 2014 RHB-103 is a proprietary oral thin film formulation of rizatriptan , the active drug in Merck & Co.'s Maxalt MLT ® A U.S. New Drug Application (NDA) for RHB-103 is currently being reviewed by the FDA with a PDUFA goal date of February 3, 2014 TEL-AVIV, Israel, Nov.
Sign-up for RedHill Biopharma Announces Positive Scientific Advice Meeting and European Marketing Application Strategy for RHB-103 (Migraine) investment picks
2014/4/7
The Company concluded a positive scientific advice meeting with the UK MHRA regarding RHB-102 and plans to submit, during the second half of the year, a European marketing application for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients RHB-102 is a proprietary, once-daily, oral pill formulation of the anti-emetic oncology support drug ondansetron The Company commenced a comparative bioavailability study with RHB-102 to support its planned European marketing application, with study results expected by July 2014 In addition to the currently pursued indications, the MHRA provided guidance regarding a new undisclosed indication which may significantly expand RHB-102's potential market; A Phase III study for this indication is planned in the U.S. for later this year TEL-AVIV, Israel, April 7, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
Sign-up for RedHill Biopharma Announces Positive European Scientific Advice Meeting Regarding RHB-102 and Plans to Submit a European Marketing Application investment picks
2014/3/27
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on February 27, 2014, support the use of LDV/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, depending on prior treatment history and whether they have cirrhosis.
Sign-up for European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection investment picks
2013/10/2
-- OMS302 Remains on Track for Planned 2014 Commercial Launch --
Sign-up for US and European Regulators Accept for Review OMS302 Marketing Applications investment picks
2014/3/3
Freescale Semiconductor (NYSE: FSL), a global leader in radio frequency (RF) power transistors , today announced the availability of 11 new commercial RF power LDMOS products that can meet the requirements of U.S. defense electronics applications.
Sign-up for Freescale Releases Its First 11 RF Power Products Suitable for U.S.-Based Defense Market Applications investment picks
2014/2/18
http://media.marketwire.com/attachments/200911/585051_584784_Logo.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1090550&ProfileId=051205&sourceType=1 BERKELEY, CA --
Sign-up for Dynavax Announces Withdrawal of European Marketing Application for HEPLISAV(TM) investment picks

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Market Applicability
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