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Soligenix' ThermoVax technology receives US patent
Clinical stage biopharmaceutical company Soligenix has received US patent for the vaccine thermostabilization technology, ThermoVax.
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Acorda obtains additional US patent for ampyra
Acorda Therapeutics has obtained additional US patent for ampyra covering a range of dosage strengths.
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ImmunoCellular obtains US patent covering use of interleukin 13-receptor alpha 2 protein
ImmunoCellular Therapeutics has obtained US patent for methods of use of interleukin 13-receptor alpha 2 protein (IL-13Rα2) in cancer immunotherapy.
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Alethia gains US patent for cancer treatment methods
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).
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TaiGen submits NDA for nemonoxacin with TFDA, CFDA
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).
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US FDA approves Xofigo as castration-resistant prostate cancer therapy
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.
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Nuvo Research wins US patent for WF10 drug candidate
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.
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Genentech, Astellas announce FDA approval of Tarceva tablets
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib).
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FDA approves Mylan Zolmitriptan ANDA
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg.
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TWi obtains FDA tentative approval for Guanfacine Hydrochloride ANDA
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
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Actinium receives notice of patent allowance for cancer treatment with alpha emitting isotopes
Biopharmaceutical company Actinium Pharmaceuticals has received notice of patent allowance for an application covering the treatment of metastatic solid cancers with alpha emitting isotopes.
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Curis announces approval of Erivedge anti-cancer drug in Australia
Oncology-focused company Curis has announced the approval of Erivedge (vismodegib) in Australia for the treatment of metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma in adult patients who are not suitable for surgery and/or radiation therapy.
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FDA accepts Merck biologics license application for allergy immunotherapy tablet
Merck, referred to as MSD outside the US and Canada, has announced the FDA acceptance of biologics license application (BLA) of investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet for review.
Regulatory Affairs > News
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Cornerstone to take over marketing rights to Pertzye in US from Digestive Care
Cornerstone Therapeutics has signed an agreement to acquire exclusive US marketing rights to Pertzye (pancrelipase) from Digestive Care (DCI).
Regulatory Affairs > News
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Warner Chilcott announces FDA approval of new oral contraceptive
Warner Chilcott has announced US FDA approval of norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets, new oral contraceptive.
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