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has reported that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) (TGRD) has withdrawn a European marketing authorisation application (MAA) for a...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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