{"id":2190,"date":"2017-06-27T17:43:59","date_gmt":"2017-06-27T12:13:59","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2190"},"modified":"2021-07-24T12:56:48","modified_gmt":"2021-07-24T07:26:48","slug":"notizia-45","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-45","title":{"rendered":"Takeda knocks Velcade; FDA nod awaited; Novartis gets approval; Astellas UK dodges; Haegarda set for launch"},"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-6a007b51ca876\" 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-6a007b51ca876\"  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-45\/#With_patent_loss_looming_Takeda_knocks_proposed_Velcade_copycats_in_FDA_petition\" >With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition<\/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-45\/#Seattle_Genetics_Takeda_hope_for_FDA_nod_for_Adcetris\" >Seattle Genetics, Takeda hope for FDA nod for Adcetris<\/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-45\/#Novartis_picks_up_FDA_approval_for_targeted_lung_cancer_meds_Tafinlar_Mekinist\" >Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist<\/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-45\/#Astellas_UK_narrowly_dodges_expulsion_after_more_trouble_with_Britains_pharma_cops\" >Astellas UK narrowly dodges expulsion after more trouble with Britain&#8217;s pharma cops<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-45\/#CSLs_Haegarda_set_for_Q3_launch_as_Shire_petitions_for_injunction\" >CSL&#8217;s Haegarda set for Q3 launch as Shire petitions for injunction<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"With_patent_loss_looming_Takeda_knocks_proposed_Velcade_copycats_in_FDA_petition\"><\/span>With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Takeda\u2019s multiple myeloma blockbuster Velcade is quickly running out of patent protection, but the drug maker has filed a citizen petition it hopes can stave off competition for a little while longer. The Japanese pharma giant asked the FDA to hold off on approving any Velcade copies until February 2018 at the earliest, arguing that changes to its med\u2019s label should, in turn, extend its exclusivity at least into next year. One exclusivity period for the drug stretches into 2022. Plus, some of the proposed copycats include different ingredients and should require further testing, Takeda contends. In its proposed knockoff, Fresenius Kabi substitutes boric acid and other ingredients for the mannitol in Velcade, Takeda says, arguing that the change \u201craises significant safety and efficacy issues that must be adequately investigated.\u201d In its petition, Takeda requests that any copycats containing boric acid instead of mannitol be supported by preclinical and human data showing they are safe and effective.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Seattle_Genetics_Takeda_hope_for_FDA_nod_for_Adcetris\"><\/span>Seattle Genetics, Takeda hope for FDA nod for Adcetris<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Seattle Genetics and Takeda\u2019s blood cancer drug Adcetris hit its primary goal in a Hodgkin\u2019s lymphoma trial. Adcetris plus three chemo drugs together held off cancer progression, the combo didn\u2019t perform dramatically better than a standard four-drug chemo regimen. In previously untreated patients with advanced Hodgkin lymphoma, those taking the Adcetris combo showed an 82.1% lower risk of cancer progression, compared with a 77.2% risk for patients on the standard-of-care chemo. Still, that 5% difference could be a tough sell with increasingly cost-conscious payers, and investors know it. Seattle Genetics\u2019 shares dropped 11% as the data were released. Overall survival numbers\u2014which, if positive, would trump the progression-free survival stats\u2014aren\u2019t likely to be in for several years. Seattle Genetics and Takeda plan to file the new data with the FDA, looking to add yet another indication to Adcetris\u2019 label. The drug is already approved for three other uses, two in patients with classical Hodgkin lymphoma, one in those with systemic anaplastic large cell lymphoma.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_picks_up_FDA_approval_for_targeted_lung_cancer_meds_Tafinlar_Mekinist\"><\/span>Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Patients in the U.S. with a specific lung cancer will soon have their first targeted treatment option with Novartis\u2019 FDA approval for Tafinlar plus Mekinist. U.S. drug regulators signed off on the combo to treat metastatic non-small cell lung cancer (NSCLC) with the BRAF V600E mutation on Thursday based on phase 2 study results showing that more than 60% of treatment-naive and previously treated patients responded to the treatment. BRAF mutations occur in about 1% to 3% of NSCLC cases around the world, according to Novartis, while BRAF V600E tumors are aggressive and leave patients with a poor prognosis. Following the approval, the Swiss drugmaker\u2019s oncology head, Bruno Strigini, said in a statement that the patient group has \u201cresponded less favorably to standard chemotherapy, suggesting that there is a critical need for a targeted therapy.\u201d The combo is available now at a price before discounts of $19,642.59 for a 30-day supply, a Novartis spokesperson told FiercePharma. Further, the drug maker estimates that it provides support to about half of patients on the combo through an assistance program, copay cards and other means.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Astellas_UK_narrowly_dodges_expulsion_after_more_trouble_with_Britains_pharma_cops\"><\/span>Astellas UK narrowly dodges expulsion after more trouble with Britain&#8217;s pharma cops<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Astellas\u2019 U.K. unit was already suspended from the Association of the British Pharmaceutical Industry thanks to what the trade group last year called \u201cserious breaches\u201d of its code of practice. And now, that suspension has been extended. The organization has tacked another 12 months onto Astellas\u2019 penalty, citing cases that \u201chave shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a &#8216;lamentable lack of concern for patient safety.&#8217;\u201d And the re-suspension very nearly became an expulsion, it noted. The extra 12 months come in response to three new cases that Astellas voluntarily served up over the course of audits this April and last September. One case \u201chighlighted a lack of oversight and training of agency nurses who delivered patient support programs, including failing to update them with product changes,\u201d the ABPI said. Two others focused on \u201cfailures to update and provide complete prescribing information for a number of medicines.\u201d All three of these instances raised \u201cvery serious concerns around patient safety, citing that Astellas UK\u2019s \u201cfailure to understand the scale of the problem was concerning.\u201d<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"CSLs_Haegarda_set_for_Q3_launch_as_Shire_petitions_for_injunction\"><\/span>CSL&#8217;s Haegarda set for Q3 launch as Shire petitions for injunction<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Even as it\u2019s tangled in a rare disease patent dispute, CSL Behring has secured FDA approval for Haegarda to prevent HAE attacks in adolescents and adults. Haegarda is the first C1 esterase inhibitor for under-the-skin attack prevention, a method Shire says violates a patent it received back in April. On the same day Shire received its patent for subcutaneous HAE treatment with a composition comprising a C1 esterase inhibitor, among other stipulations, the Irish drugmaker sued Australia\u2019s CSL to block its Haegarda launch. Shire markets HAE meds Cinryze, Firazyr and Kalbitor already, and it&#8217;s working on a subcutaneous prophylactic C1 esterase inhibitor dubbed SHP616, among other candidates. At the time, CSL countered that it &#8220;remains highly confident&#8221; its drug &#8220;does not infringe any valid claim of the Shire ViroPharma patent and will vigorously defend against the claims.&#8221; The company says Haegarda \u201cis the product of independent research and development work at CSL Behring.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition Takeda\u2019s multiple myeloma blockbuster Velcade is quickly running out of patent protection, but the drug maker has filed a citizen petition it hopes can stave off competition for a little while longer. The Japanese pharma giant asked the FDA to hold off on [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1247,"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":[684,709,704,730,423,947,17313,639,502,534,554],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-2190","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-astellas","tag-ema","tag-fda","tag-notizia","tag-novartis","tag-orphan-designation","tag-orphan-drug","tag-pharma-news","tag-rare-disease","tag-seattle-genetics","tag-takeda","industry-pharmaceutical","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\">Astellas<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">EMA<\/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\">Notizia<\/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\">Orphan Designation<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Orphan Drug<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rare Disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Seattle Genetics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Takeda<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Astellas<\/span>","<span class=\"advgb-post-tax-term\">EMA<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Notizia<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Orphan Designation<\/span>","<span class=\"advgb-post-tax-term\">Orphan Drug<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">Rare Disease<\/span>","<span class=\"advgb-post-tax-term\">Seattle Genetics<\/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 Jun 27, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Jun 27, 2017 5:43 pm","modified":"Updated on Jul 24, 2021 12:56 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