{"id":2100,"date":"2017-05-02T17:54:25","date_gmt":"2017-05-02T12:24:25","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2100"},"modified":"2021-07-24T12:56:44","modified_gmt":"2021-07-24T07:26:44","slug":"notizia-37","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-37","title":{"rendered":"FDA Approves; AZ nabs; Nordisk settles; Novartis pays"},"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-69f39011d6815\" 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-69f39011d6815\"  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-37\/#FDA_Approves_Alunbrig_brigatinib_for_Rare_Lung_Cancer\" >FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer<\/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-37\/#AZ_nabs_FDA_nod_for_bladder_cancer_for_checkpoint_med_Imfinzi\" >AZ nabs FDA nod for bladder cancer for checkpoint med Imfinzi<\/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-37\/#Novo_Nordisk_to_settle_med-whistleblower_suit\" >Novo Nordisk to settle med-whistleblower suit<\/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-37\/#Novartis_to_pay_50M_lose_some_drug_coverage_in_Korean_bribery_probe\" >Novartis to pay $50M, lose some drug coverage in Korean bribery probe<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Alunbrig_brigatinib_for_Rare_Lung_Cancer\"><\/span>FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, the patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food. Brigatinib has an orphan drug designation for this indication and Takeda received an Accelerated Approval of the drug based on tumor response rate and duration of response. An Accelerated Approval means Takeda can market the drug now but additional studies (i.e., a phase 3 clinical trial) may be needed by the FDA moving forward.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"AZ_nabs_FDA_nod_for_bladder_cancer_for_checkpoint_med_Imfinzi\"><\/span>AZ nabs FDA nod for bladder cancer for checkpoint med Imfinzi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">AstraZeneca got its first FDA approval with its checkpoint inhibitor Imfinzi (durvalumab), as the British pharma giant picked up an accelerated green light in urothelial carcinoma. This makes the company the third Big Pharma player to enter the advanced bladder cancer space with a PD-1\/PD-L1 inhibitor. Imfinzi will take on established player Tecentriq from Roche, which hit the scene last May, and Opdivo, the Bristol-Myers Squibb entrant that won its bladder go-ahead in February. Merck is still chasing a bladder cancer nod for its contender, Keytruda. Imfinzi, though, will roll out at a higher price point than its nemeses; as estimated average monthly cost of the med will be $15,000, compared with its rivals&#8217; $12,500. The approval comes based on a single-arm, 182-patient trial, which produced an overall response rate of 26.3% among the 95 patients with high PD-L1 scores. As Tecentriq does, Imfinzi goes hand in hand with a complementary diagnostic from Ventana that assesses PD-L1 levels in tumors.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novo_Nordisk_to_settle_med-whistleblower_suit\"><\/span>Novo Nordisk to settle med-whistleblower suit<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Novo Nordisk has moved to settle a whistleblower lawsuit alleging the company ran a \u201cwhite-coat marketing scheme\u201d to pump up sales of NovoLog, Victoza and Levemir. According to the suit, recently unsealed as part of the settlement process\u2014Novo Nordisk partnered with a clinical education company, Healthstar\u2019s PT, to set up a program dubbed Changing Life with Diabetes. The group hired and trained certified diabetes educators (CDEs), according to the suit, which was brought by two former managers and more than two dozen states. The whistleblowers claim that since 2006, Novo ran the program to gain crucial access to physician practices, where CDEs would provide thousands of dollars\u2019 worth of educational programs and materials. The idea behind the program, according to the suit, was to induce prescribers to write scripts for Novo\u2019s diabetes meds by offering such services. Due to this, U.S. pricing pressures have taken a toll at Novo lately, forcing the company to cast off 1,000 staffers last fall.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_to_pay_50M_lose_some_drug_coverage_in_Korean_bribery_probe\"><\/span>Novartis to pay $50M, lose some drug coverage in Korean bribery probe<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For more than a year, Novartis has been under investigation in Korea for allegedly bribing doctors to pump up sales. Now, the Swiss drug giant is learning about its punishment in the country as authorities there decided to issue a fine of nearly $50 million. On a preliminary basis, Korea\u2019s Ministry of Health &amp; Welfare (MHW) has fined Novartis 55 billion Korean won, approximately $50 million, and suspended reimbursement of Exelon and Zometa for three months. The final decision is expected by the end of May. Previously, authorities were weighing a suspension of the company\u2019s big-selling cancer med Glivec, according to The Korea Times, but feared that move would leave some 3,000 to 5,000 chronic myeloid leukemia patients with no other options.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1965,"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":[17517,2063,137,704,365,420,423,877,712,17516,554],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-2100","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alunbrig","tag-bladder-cancer","tag-cancer","tag-fda","tag-lung-cancer","tag-news","tag-novartis","tag-novo-nordisk","tag-pharma-industry","tag-rare-lung-cancer","tag-takeda","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized 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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\">Alunbrig<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">bladder cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Lung Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novartis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novo Nordisk<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pharma Industry<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rare Lung Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Takeda<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Alunbrig<\/span>","<span class=\"advgb-post-tax-term\">bladder cancer<\/span>","<span class=\"advgb-post-tax-term\">Cancer<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Lung Cancer<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Novo Nordisk<\/span>","<span class=\"advgb-post-tax-term\">Pharma Industry<\/span>","<span class=\"advgb-post-tax-term\">Rare Lung Cancer<\/span>","<span class=\"advgb-post-tax-term\">Takeda<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on May 2, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on May 2, 2017 5:54 pm","modified":"Updated on Jul 24, 2021 12:56 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