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FDA Approves Carbaglu For Hyperammonemia
FDA has approved Carbaglu (carglumic acid) tablets to treat a condition known as hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency that results in elevation of ammonia levels in th...
Published: 19-Mar-2010
Somaxon Pharma's Insomnia Drug Gets FDA Approval
Somaxon Pharmaceuticals (Somaxon) has received FDA approval for new drug application (NDA) of Silenor (doxepin) for the treatment of insomnia characterised by difficulty with sleep maintenance. ...
Published: 19-Mar-2010
Adienne Pharma Receives EMA Grant For Tepadina Marketing Authorisation
Adienne Pharma & Biotech (Adienne Pharma) and Riemser Arzneimittel have reported that the European Medicines Agency (EMA) has granted exclusive marketing authorisation to Adienne Pharma's orphan medic...
Published: 19-Mar-2010
Takeda Withdraws MAA For Prolonged-Release Formulation Of Competact
Takeda Pharmaceutical has reported that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) (TGRD) has withdrawn a European marketing authorisation application (MAA) for a...
Published: 19-Mar-2010
FDA Accepts NDA Of Onglyza In Combination With Extended Release Metformin
Bristol-Myers Squibb and AstraZeneca have reported that FDA has accepted for review a new drug application (NDA) for an investigational fixed dose combination of Onglyza (saxagliptin), a dipeptidyl pe...
Published: 18-Mar-2010
Novartis Pharma Gets EU Approval For Menveo
Novartis Pharma has received European Commission (EC) approval for marketing authorisation of Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) in all 27 European member states. ...
Published: 18-Mar-2010
USPTO Allows Regulus Stanford Patent Application Covering miR-181a Function In Immune Cells
Regulus Therapeutics has reported that the US Patent and Trademark Office (USPTO) has allowed claims in US Application Serial No 11/977,506 covering methods of antagonising miR-181a to regulate immune...
Published: 17-Mar-2010
Glenmark Generics, Konec Receive Order From FDA To Stop Marketing Unapproved Nitroglycerin Tablets
FDA has ordered Glenmark Generics and Konec of Tucson, Ariz, to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack...
Published: 17-Mar-2010
Savient Pharma Refiles Biologics License Application For Krystexxa
Savient Pharma has resubmitted its biologics license application (BLA) to FDA for Krystexxa (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. ...
Published: 16-Mar-2010
Eli Lilly, Amylin Pharma, Alkermes Receive Complete Response Letter For Bydureon
Eli Lilly, Amylin Pharma and Alkermes have received complete response letter from FDA regarding the new drug application (NDA) for Bydureon (exenatide for extended-release injectable suspension). ...
Published: 15-Mar-2010
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