{"id":2116,"date":"2017-05-09T17:26:34","date_gmt":"2017-05-09T11:56:34","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2116"},"modified":"2021-07-24T12:56:45","modified_gmt":"2021-07-24T07:26:45","slug":"notizia-38","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-38","title":{"rendered":"Lilly moves ahead; Authorities raid; Bristol-Myers, AZ in legal; PhRMA expected to weed out"},"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-6a0521b616bb1\" 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-6a0521b616bb1\"  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-38\/#Lilly_moves_forward_with_biologics_plant_expansion_in_Ireland\" >Lilly moves forward with biologics plant expansion in Ireland<\/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-38\/#Brazilian_authorities_raid_Alexion_office_in_another_sales-practices_probe\" >Brazilian authorities raid Alexion office in another sales-practices probe<\/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-38\/#Bristol-Myers_AstraZeneca_in_legal_hot_seat_over_Onglyza_heart_failure_warning\" >Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning<\/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-38\/#PhRMA_expected_to_weed_out_some_members_with_new_R_D_rules\" >PhRMA expected to weed out some members with new R&amp;D rules<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Lilly_moves_forward_with_biologics_plant_expansion_in_Ireland\"><\/span>Lilly moves forward with biologics plant expansion in Ireland<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. The construction might begin in coming months and commissioning will begin in 2019. The expansion is expected to add about 130 workers to the site by 2020. As negotiations are underway, specifics of the investment are not being released. Earlier reports put the cost at about \u20ac200 million. The site also does API production for a host of small molecule drugs. Last year, the company said it would invest nearly $40 million (\u20ac35 million) to build a continuous manufacturing facility. Tremors of concern spread through Ireland in February when Lilly said it halted preparations for the project. That ignited speculation among some politicians that Lilly might divert funds to the U.S. after President Trump held a meeting with pharma execs in which he urged them to invest in U.S. manufacturing.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Brazilian_authorities_raid_Alexion_office_in_another_sales-practices_probe\"><\/span>Brazilian authorities raid Alexion office in another sales-practices probe<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Alexion\u2019s sales practices are under the lens again. Just four months after concluding its top brass inappropriately pressured staff to pad Soliris sales in the U.S., Brazilian authorities raided the company\u2019s Sao Paulo offices as part of an investigation into its marketing there. Brazil\u2019s police are probing whether the Connecticut-based biotech, helped by Brazilian patient association Associacao dos Familiares, Amigos e Portadores de Doen\u00e7as Graves (AFAG), subsidized lawsuits for patients to gain access to an Alexion drug through Brazil\u2019s national health system. AFAG, to which Alexion has said it gives financial support, was also searched. Law enforcement officials have turned up evidence showing that some of the lawsuits\u2014which number more than 900 in the last six years\u2014were fraudulent and used fake diagnoses to help reel in patients. Through those lawsuits, Alexion drummed up $400 million in sales from the Brazilian government in that time period, the warrant request says.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Bristol-Myers_AstraZeneca_in_legal_hot_seat_over_Onglyza_heart_failure_warning\"><\/span>Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Last year, the FDA called for stronger heart-failure warnings on the label of AstraZeneca Type 2 diabetes med Onglyza. And now, AstraZeneca and former partner Bristol-Myers Squibb are being hit with 14 lawsuits related to the med\u2019s heart failure risks. The suits, filed in the District of New Jersey, claim the drug makers failed to warn users that Onglyza and related combo product Kombiglyza XR can cause cardiac arrest, congestive heart failure, and death. The pharma pair began marketing Onglyza in 2009 before conducting clinical trials to see whether it upped patients\u2019 cardiac risks, the plaintiffs allege, ignoring 2008 FDA guidance that urged companies to \u201cdemonstrate that\u201d new therapies \u201cwill not result in an unacceptable increase in cardiovascular risk.\u201d AstraZeneca, for its part, &#8220;is confident in the safety and efficacy of Onglyza, when used in accordance with the FDA-approved label, which has been established through clinical trials. We will vigorously defend against the allegations made by the plaintiffs,&#8221; a spokeswoman said in a statement.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"PhRMA_expected_to_weed_out_some_members_with_new_R_D_rules\"><\/span>PhRMA expected to weed out some members with new R&amp;D rules<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">PhRMA, which has already rid itself of a couple of members who had brought unwanted attention to the industry for their practice of jacking up prices, will vote on new membership rules that are expected to trim its membership, and hopefully criticism, even further. PhRMA spokeswoman Holly Campbell said today she could not discuss details of the new rules ahead of tomorrow&#8217;s vote. The group began reviewing its bylaws to focus on \u201cresearch-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients,\u201d as public criticism over drug pricing has escalated. PhRMA&#8217;s new rules will require members to invest at least $200 million a year on average over three years of research and development. Their R&amp;D budgets would also have to equal at least 10% of their global sales.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lilly moves forward with biologics plant expansion in Ireland Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. The construction might begin in coming months and commissioning will begin in 2019. The expansion is expected to add about 130 [&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":[885,96,784,228,420,17520,712,884],"industry":[17225],"therapeutic_areas":[17242],"class_list":["post-2116","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alexion","tag-astrazeneca","tag-bms","tag-eli-lilly","tag-news","tag-onglyza","tag-pharma-industry","tag-phrma","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases"],"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\/ -->\n<title>Lilly moves ahead; Authorities raid; Bristol-Myers, AZ in legal<\/title>\n<meta name=\"description\" content=\"Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. 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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\">Alexion<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">AstraZeneca<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">BMS<\/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\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Onglyza<\/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\">PhRMA<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Alexion<\/span>","<span class=\"advgb-post-tax-term\">AstraZeneca<\/span>","<span class=\"advgb-post-tax-term\">BMS<\/span>","<span class=\"advgb-post-tax-term\">Eli Lilly<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Onglyza<\/span>","<span class=\"advgb-post-tax-term\">Pharma Industry<\/span>","<span class=\"advgb-post-tax-term\">PhRMA<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on May 9, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on May 9, 2017 5:26 pm","modified":"Updated on Jul 24, 2021 12:56 pm"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2116","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=2116"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2116\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/1965"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=2116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=2116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=2116"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=2116"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=2116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}