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Regulatory Affairs

FDA clears Omeros' IND for OMS824 in Huntington's disease By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease.
Regulatory Affairs > News
Johnson & Johnson plans to submit over 10 new drugs for regulatory approval by 2017 By PBR Staff Writer
Johnson & Johnson's Pharmaceuticals unit Janssen is planning to submit more than 10 new products for regulatory approval and extend the brand pipeline of 25 existing drugs by 2017.
Regulatory Affairs > News Soligenix' ThermoVax technology receives US patent By PBR Staff Writer
Clinical stage biopharmaceutical company Soligenix has received US patent for the vaccine thermostabilization technology, ThermoVax.
Regulatory Affairs > News
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Acorda obtains additional US patent for ampyra
21 May 2013 | By PBR Staff Writer
Acorda Therapeutics has obtained additional US patent for ampyra covering a range of dosage strengths.
Regulatory Affairs > News
ImmunoCellular obtains US patent covering use of interleukin 13-receptor alpha 2 protein
20 May 2013 | By PBR Staff Writer
ImmunoCellular Therapeutics has obtained US patent for methods of use of interleukin 13-receptor alpha 2 protein (IL-13Rα2) in cancer immunotherapy.
Regulatory Affairs > News
Alethia gains US patent for cancer treatment methods
17 May 2013 | By PBR Staff Writer
Alethia Biotherapeutics has gained US patent for methods of treating carcinomas with antibodies targeting the region of secreted clusterin (sCLU) responsible for promoting epithelial-to-mesenchymal transition (EMT).
Regulatory Affairs > News
TaiGen submits NDA for nemonoxacin with TFDA, CFDA
17 May 2013 | By PBR Staff Writer
TaiGen Biotechnology has submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA).
Regulatory Affairs > News
US FDA approves Xofigo as castration-resistant prostate cancer therapy
16 May 2013 | By PBR Staff Writer
The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men.
Regulatory Affairs > News
Nuvo Research wins US patent for WF10 drug candidate
16 May 2013 | By PBR Staff Writer
Canada-based pharmaceutical company Nuvo Research has received US Patent relating to compositions and methods of using WF10 and new derivative formulations for the treatment of allergic asthma, allergic rhinitis and atopic dermatitis.
Regulatory Affairs > News
Genentech, Astellas announce FDA approval of Tarceva tablets
16 May 2013 | By PBR Staff Writer
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib).
Regulatory Affairs > News
FDA approves Mylan Zolmitriptan ANDA
16 May 2013 | By PBR Staff Writer
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg.
Regulatory Affairs > News
TWi obtains FDA tentative approval for Guanfacine Hydrochloride ANDA
15 May 2013 | By PBR Staff Writer
Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg.
Regulatory Affairs > News
Actinium receives notice of patent allowance for cancer treatment with alpha emitting isotopes
15 May 2013 | By PBR Staff Writer
Biopharmaceutical company Actinium Pharmaceuticals has received notice of patent allowance for an application covering the treatment of metastatic solid cancers with alpha emitting isotopes.
Regulatory Affairs > News
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In The Spotlight

FDA clears Omeros' IND for OMS824 in Huntington's disease
Johnson & Johnson plans to submit over 10 new drugs for regulatory approval by 2017
Soligenix' ThermoVax technology receives US patent
Acorda obtains additional US patent for ampyra
ImmunoCellular obtains US patent covering use of interleukin 13-receptor alpha 2 protein

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