{"id":11011,"date":"2020-10-13T15:43:33","date_gmt":"2020-10-13T10:13:33","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=11011"},"modified":"2021-07-24T12:58:07","modified_gmt":"2021-07-24T07:28:07","slug":"pharma-happenings-for-az-alkermes-innovent-lillys-avenue","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-az-alkermes-innovent-lillys-avenue","title":{"rendered":"US\/AZ deal; Alkermes&#8217; Schizophrenia drug; Innovent\/Lilly&#8217;s China market expansion; Rejection for Avenue"},"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-69fae4d733b46\" 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-69fae4d733b46\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-az-alkermes-innovent-lillys-avenue\/#US_AstraZeneca_strikes_an_antibody_treatment_USD_486_million_deal\" >U.S., AstraZeneca strikes an antibody treatment USD 486 million deal<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-az-alkermes-innovent-lillys-avenue\/#FDA_advisory_panel_clears_Alkermes_Schizophrenia_drug_ALKS_3831\" >FDA advisory panel clears Alkermes&#8217; Schizophrenia drug, ALKS 3831<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-az-alkermes-innovent-lillys-avenue\/#InnoventLillys_rituximab_injection_receives_a_green_signal_in_China\" >Innovent\/Lilly\u2019s rituximab injection receives a green signal in China&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-az-alkermes-innovent-lillys-avenue\/#FDA_rejects_NDA_filed_by_Avenue_Therapeutics_drug_for_IV_Tramadol\" >FDA rejects NDA filed by Avenue Therapeutics drug for IV Tramadol<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"US_AstraZeneca_strikes_an_antibody_treatment_USD_486_million_deal\"><\/span><strong>U.S., AstraZeneca strikes an antibody treatment USD 486 million deal<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The U.S. government awarded the pharma giant AstraZeneca a sum of USD 486 million for the development of up to 100,000 corona vaccine doses. The deal, under Operation Warp Speed, will people the manufacturing of antibody doses and facilitate the smooth conducting of Phase III trials.&nbsp;<\/p>\n\n\n\n<p>AstraZeneca\u2019s antibody treatment, although, is similar to Regeneron\u2019s antibody cocktail treatment, however, its vaccine, which is a combination of two LAABs derived from patients who recovered from COVID-19, has the potential to not only treat but also prevent the spread of the virus in already infected <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape\" target=\"_blank\" rel=\"noreferrer noopener\">COVID-19 <\/a>patients.&nbsp;<\/p>\n\n\n\n<p>The decision is in response to rising cases of COVID-19 throughout America. The US government hopes to get access to enough experimental antibody treatments for its citizens. As of today, the US has reported over 7 Million confirmed cases of COVID-19 with deaths surpassing 214 K.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_advisory_panel_clears_Alkermes_Schizophrenia_drug_ALKS_3831\"><\/span><strong>FDA advisory panel clears Alkermes&#8217; Schizophrenia drug, ALKS 3831<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Alkermes\u2019 experimental antipsychotic drug, ALKS 3831 (olanzapine\/samidorphan) for <a href=\"https:\/\/www.delveinsight.com\/report-store\/schizophrenia-market\" target=\"_blank\" rel=\"noreferrer noopener\">schizophrenia<\/a> and bipolar I disorder received clearance from the US FDA expert advisory committee review.&nbsp;<\/p>\n\n\n\n<p>The company is planning to file for approval in both <a href=\"https:\/\/www.delveinsight.com\/blog\/schizophrenia-market\/\" target=\"_blank\" rel=\"noreferrer noopener\">schizophrenia<\/a> and bipolar I disorder based on a six-month trial in which ALKS 3831 bested Zyprexa on measures of weight gain.&nbsp;<\/p>\n\n\n\n<p>Although there were hurdles as the authority has concerned regarding the effects of an opioid antagonist on patients, including painkilling effects, withdrawal symptoms, and overdose. However, the drug received an overwhelming response from the committees &#8211; The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"InnoventLillys_rituximab_injection_receives_a_green_signal_in_China\"><\/span><strong>Innovent\/Lilly\u2019s rituximab injection receives a green signal in China&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Innovent Biologics and Eli Lilly jointly announced the approval of commercialization of their rituximab injection, Halpryza, in the Chinese market for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-market\" target=\"_blank\" rel=\"noreferrer noopener\">diffuse large B cell lymphoma (DLBCL)<\/a>, follicular lymphoma, and chronic lymphocytic leukemia.&nbsp;&nbsp;<\/p>\n\n\n\n<p>The collaboration between the companies started in 2015, and this joint venture is an expansion of the one done for Tyvyt (sintilimab injection). The duo has developed and launched Tyvyt in China, which further expanded to developing three antibodies for oncology indications, a diabetes treatment, besides Halpryza.<\/p>\n\n\n\n<p>Rituximab injections have long been available in the pharmaceutical market, first approved by the USFDA in 1997, and is recommended for <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-hodgkins-lymphoma-nhl-market\" target=\"_blank\" rel=\"noreferrer noopener\">non-Hodgkin\u2019s lymphoma<\/a>, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and moderate to severe pemphigus vulgaris.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_rejects_NDA_filed_by_Avenue_Therapeutics_drug_for_IV_Tramadol\"><\/span><strong>FDA rejects NDA filed by Avenue Therapeutics drug for IV Tramadol<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Avenue Therapeutics has announced the rejection from the USFDA for its New Drug Application for its intravenous formulation of tramadol due to safety issues for the US market.&nbsp;<\/p>\n\n\n\n<p>The company noted that Phase III trial results demonstrated statistically significant results and met all the primary and many secondary endpoints. However, the US FDA has rejected the NDA, stating concerns over the potential necessity and safety of patients to use an opioid to treat their pain alongside tramadol in the Complete Response Letter. Further, there are concerns over opioid \u201cstacking\u201d and a likelihood of increased chances of opioid-related adverse effects.&nbsp;<\/p>\n\n\n\n<p>The company believes that the IV formulation of tramadol has the potential to emerge as an efficient treatment option for patients in the US and plans to resolve the issues raised.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>U.S., AstraZeneca strikes an antibody treatment USD 486 million deal The U.S. government awarded the pharma giant AstraZeneca a sum of USD 486 million for the development of up to 100,000 corona vaccine doses. The deal, under Operation Warp Speed, will people the manufacturing of antibody doses and facilitate the smooth conducting of Phase III [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":11017,"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":[1616,96,16716,12513,228,1315,16707],"industry":[17225],"therapeutic_areas":[],"class_list":["post-11011","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alkermes","tag-astrazeneca","tag-avenue-therapeutics","tag-covid-19-news","tag-eli-lilly","tag-innovent-biologics","tag-schizophrenia-market","industry-pharmaceutical"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COVID-19 News<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Eli Lilly<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Innovent Biologics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Schizophrenia market<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Alkermes<\/span>","<span class=\"advgb-post-tax-term\">AstraZeneca<\/span>","<span class=\"advgb-post-tax-term\">Avenue Therapeutics<\/span>","<span class=\"advgb-post-tax-term\">COVID-19 News<\/span>","<span class=\"advgb-post-tax-term\">Eli Lilly<\/span>","<span class=\"advgb-post-tax-term\">Innovent Biologics<\/span>","<span class=\"advgb-post-tax-term\">Schizophrenia market<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 6 years ago","modified":"Updated 5 years 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