Pharmaceutical-business-review - regulatoryaffairs.pharmaceutical-business-review.com - PBR - Regulatory Affairs News

Latest News:

OncoMed announces issuance of US patent for vantictumab 23 Aug 2013 | 12:41 pm

Clinical-stage company OncoMed Pharmaceuticals has announced the issuance of US patent for methods of treating cancer with its antibody vantictumab (OMP-18R5) through 2029.

Mylan wins FDA approval for bupropion hydrochloride extended-release tablets sANDA 23 Aug 2013 | 11:00 am

Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL),...

Galena announces European patent notification for pharmaceutical use of NeuVax 22 Aug 2013 | 04:50 pm

Biopharmaceutical company Galena Biopharma has announced patent notification from the European Patent Office for pharmaceutical use of NeuVax (nelipepimut-S) as a vaccine for the prevention of relapse...

Alnylam obtains additional orphan drug designation for ALN-AT3 from FDA 21 Aug 2013 | 10:49 am

RNAi therapeutics company Alnylam Pharmaceuticals has obtained additional orphan drug designation from US FDA for a RNAi therapeutic, ALN-AT3, to treat hemophilia A.

Supernus to launch Trokendi extended release formulation to treat epilepsy 20 Aug 2013 | 12:35 pm

Specialty pharmaceutical company Supernus Pharmaceuticals is set to launch once-daily extended release formulation of topiramate, Trokendi XR, to treat epilepsy following the final FDA approval.

Cell Therapeutics' aggressive non-hodgkin lymphoma treatment wins market access in France 19 Aug 2013 | 12:56 pm

The Transparency Commission of the French National Health Authority has granted market access for Cell Therapeutics' (CTI) aggressive non-hodgkin lymphoma treatment, Pixuvri (pixantrone) in France.

GW Pharma submits IND application with US FDA for Sativex phase III clinical trial 16 Aug 2013 | 04:46 pm

GW Pharma has submitted a phase III investigational new drug (IND) application with the US FDA to conduct a pivotal Sativex efficacy and safety clinical program to treat spasticity due to Multiple Scl...

Novartis' Bexsero vaccine receives Australian approval for MenB disease 16 Aug 2013 | 10:52 am

The Australian Therapeutic Goods Administration (TGA) has granted approval for Novartis' multi-component Meningococcal B (MenB) vaccine, Bexsero, for use against a dangerous form of bacterial meningit...

Apricus Vitaros wins approvals in Netherlands 16 Aug 2013 | 04:00 am

The Irish Medicines Board and the Netherlands' Medicines Evaluations Board have granted national phase approvals to Apricus Biosciences' Vitaros, indicated to treat patients with erectile dysfunction ...

US FDA approves Silvergate Pharmaceuticals' Epaned to treat hypertension 15 Aug 2013 | 05:00 pm

The US FDA has approved Silvergate Pharmaceuticals' Epaned (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people aged one month and more.

Recently parsed news:

Recent searches: