Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs | News
Search Refinements

Regulatory Affairs News

View news from other Pharmaceutical sectors:
1-15 of 2019 results
Achillion gains FDA fast track designation for NS5A inhibitor against HCV
16 May 2012 | By PBR Staff Writer
The FDA has granted fast track designation for Achillion Pharmaceuticals' ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV).
Regulatory Affairs > News
SCH grants approval to manufacture, import drugs
15 May 2012 | By PBR Staff Writer
The Qatar's Supreme Council of Health (SCH) has granted approval to five companies to establish manufacturing units for producing medicines and pharmaceutical products locally.
Regulatory Affairs > News
Ohr wins composition of matter patents in US, Europe
15 May 2012 | By PBR Staff Writer
Ohr Pharmaceutical has gained US and European patients entitled, preparation of a therapeutic composition.
Regulatory Affairs > News
Arno gains orphan-drug status for AR-42 in Europe
14 May 2012 | By PBR Staff Writer
Arno Therapeutics has received orphan-drug designation for AR-42 to treat neurofibromatosis type 2 (NF2) in the Europe.
Regulatory Affairs > News
FDA advisory committee recommends Gilead HIV drug
14 May 2012 | By PBR Staff Writer
The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults.
Regulatory Affairs > News
Cell Therapeutics' Pixuvri receives European Union approval
11 May 2012 | By PBR Staff Writer
The European Commission (EC) has awarded a conditional marketing authorization approval for Cell Therapeutics' Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL).
Regulatory Affairs > News
Janssen seeks FDA approval for Xarelto
10 May 2012 | By PBR Staff Writer
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).
Regulatory Affairs > News
FDA Arthritis Advisory Committee recommends approval of Pfizer Tofacitinib
10 May 2012 | By PBR Staff Writer
The FDA Arthritis Advisory Committee has recommended the approval of Pfizer's Tofacitinib for adult patients with moderately to severely active rheumatoid arthritis (RA).
Regulatory Affairs > News
Watson confirms ANDA filing to market Shire Lialda
10 May 2012 | By PBR Staff Writer
Shire Development, Shire Pharmaceutical Development, Cosmo Technologies and Guiliani International have filed a suit against Watson in the US District Court for the Southern District of Florida to prevent Watson from marketing its abbreviated new drug application (ANDA) product before the expiration of US Patent number 6,773,720.
Regulatory Affairs > News
FDA approves Clinigen sNDA for Foscavir
08 May 2012 | By PBR Staff Writer
The FDA has approved Clinigen Healthcare's supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes.
Regulatory Affairs > News
Vivus wins NDA approval for erectile dysfunction therapy in US
08 May 2012 | By PBR Staff Writer
Vivus has received NDA approval for TA-1790 (avanafil), indicated for the treatment of erectile dysfunction (ED), in the US.
Regulatory Affairs > News
Astellas announces favorable court ruling in Tarceva patent infringement suit
07 May 2012 | By PBR Staff Writer
Astellas Pharma has announced favorable US court ruling in patent infringement case for OSI Pharmaceuticals, Genentech, a member of the Roche Group, and Pfizer.
Regulatory Affairs > News
Pain Therapeutics wins four US patents for Remoxy
04 May 2012 | By PBR Staff Writer
Pain Therapeutics, a biopharmaceutical company, has received four US patents covering Remoxy (oxycodone) extended-release capsules CII.
Regulatory Affairs > News
EC grants orphan drug designation to Sunesis Vosaroxin drug
04 May 2012 | By PBR Staff Writer
The European Commission (EC) has granted orphan drug designation to Sunesis Pharmaceuticals' Vosaroxin drug.
Regulatory Affairs > News
Janssen Research submits new drug applications to FDA for Xarelto
03 May 2012 | By PBR Staff Writer
Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant.
Regulatory Affairs > News
1-15 of 2019 results