{"id":1857,"date":"2017-02-07T11:54:32","date_gmt":"2017-02-07T11:54:32","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1857"},"modified":"2021-07-24T12:56:39","modified_gmt":"2021-07-24T07:26:39","slug":"notizia-25","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-25","title":{"rendered":"FDA approves; Sun Pharma Recalls; Mezzion filed; Sanofi\u2019s antibody to treat"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a0e2a50ec1fb\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a0e2a50ec1fb\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-25\/#FDA_approves_Bristol-Myers_Squibbs_Opdivo_injection_to_treat_mUC\" >FDA approves Bristol-Myers Squibb\u2019s Opdivo injection to treat mUC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-25\/#Sun_Pharma_Recalls_27_Lakh_Bottles_of_Antidepressant\" >Sun Pharma Recalls 2.7 Lakh Bottles of Antidepressant<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-25\/#Mezzion_Pharma_has_filed_a_suit_against_Dr_Reddys_Laboratories_in_the_US\" >Mezzion Pharma has filed a suit against Dr Reddy&#8217;s Laboratories in the US<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-25\/#Sanofis_antibody_to_treat_patients_with_rheumatoid_arthritis_gets_Approved\" >Sanofi\u2019s antibody to treat patients with rheumatoid arthritis gets Approved<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"FDA_approves_Bristol-Myers_Squibbs_Opdivo_injection_to_treat_mUC\"><\/span>FDA approves Bristol-Myers Squibb\u2019s Opdivo injection to treat mUC<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Bristol-Myers Squibb\u2019s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumour response rate and duration of response and its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The company received the application priority review and breakthrough therapy designation for Opdivo from the FDA to treat patients with locally advanced or mUC.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Sun_Pharma_Recalls_27_Lakh_Bottles_of_Antidepressant\"><\/span>Sun Pharma Recalls 2.7 Lakh Bottles of Antidepressant<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Sun Pharma is recalling over 2.7 lakh bottles of bupropion hydrochloride extended-release tablets used for treatment of major depressive disorders in the US due to failed dissolution specifications. The recall is being initiated by Sun Pharmaceutical Industries Inc. for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Mezzion_Pharma_has_filed_a_suit_against_Dr_Reddys_Laboratories_in_the_US\"><\/span>Mezzion Pharma has filed a suit against Dr Reddy&#8217;s Laboratories in the US<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Mezzion has filed a suit for damages against Dr. Reddy&#8217;s in New Jersey State Court alleging that Dr. Reddy&#8217;s committed fraud relating to the latter hiding significant deficiencies in its Food and Drug Administration (FDA) cGMP practices, and misrepresenting its compliance to Mezzion. According to Dr. Reddy\u2019s, they have not been served with any legal papers or legal process in the matter referred to in Mezzion&#8217;s press release. In 2015, Dr. Reddy&#8217;s had received a warning letter from the US Food and Drug Administration (USFDA) for two of its active pharma ingredients (API) manufacturing plants and a formulation facility located in Andhra Pradesh and Telangana.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Sanofis_antibody_to_treat_patients_with_rheumatoid_arthritis_gets_Approved\"><\/span>Sanofi\u2019s antibody to treat patients with rheumatoid arthritis gets Approved<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Sanofi has received approval from Health Canada for Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, to treat adult patients with moderately to severely active rheumatoid arthritis (RA). The approval was based on data from about 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. The fully human monoclonal antibody Kevzara binds specifically to soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA approves Bristol-Myers Squibb\u2019s Opdivo injection to treat mUC Bristol-Myers Squibb\u2019s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumour response rate and duration of response and its continued approval [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1173,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[130,180,204,356,17437,479,533,802,558],"industry":[17225],"therapeutic_areas":[17245,17228],"class_list":["post-1857","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-bristol-myers-squibb","tag-competitive-landscape","tag-delveinsight","tag-licensing-opportunities","tag-mezzion-pharma","tag-pipeline-coverage","tag-sanofi","tag-sun-pharma","tag-technology-assessments","industry-pharmaceutical","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Bristol-Myers Squibb<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Competitive landscape<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">DelveInsight<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">licensing opportunities<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Mezzion Pharma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pipeline coverage<\/a>","<a 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5 years ago"},"absolute_dates":{"created":"Posted on Feb 7, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Feb 7, 2017 11:54 am","modified":"Updated on Jul 24, 2021 12:56 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