{"id":1923,"date":"2017-02-28T12:02:42","date_gmt":"2017-02-28T12:02:42","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1923"},"modified":"2021-07-24T12:56:41","modified_gmt":"2021-07-24T07:26:41","slug":"notizia-28","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-28","title":{"rendered":"Prosecutors rope Pfizer; Pharma groups to FDA; Regeneron simulates; Otsuka &#038; Lundbeck revive;Philidor execs plead"},"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-6a0e02fa23c4d\" 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-6a0e02fa23c4d\"  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-28\/#Prosecutors_rope_Pfizer_into_fast-growing_copay_assistance_probe\" >Prosecutors rope Pfizer into fast-growing copay assistance probe<\/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-28\/#Pharma_groups_to_FDA_Stop_that_new_off-label_rule_in_its_tracks\" >Pharma groups to FDA: Stop that new off-label rule in its tracks<\/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-28\/#Regeneron_simulates_retinal_disease_with_virtual_and_augmented_reality_app\" >Regeneron simulates retinal disease with virtual and augmented reality app<\/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-28\/#Otsuka_and_Lundbeck_revive_Rexulti_mask_campaign_as_US_uptake_soars\" >Otsuka and Lundbeck revive Rexulti mask campaign as U.S. uptake soars<\/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-28\/#Former_Valeant_Philidor_execs_plead_not_guilty_to_multimillion-dollar_fraud_and_kickback_charges\" >Former Valeant, Philidor execs plead not guilty to multimillion-dollar fraud and kickback charges<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Prosecutors_rope_Pfizer_into_fast-growing_copay_assistance_probe\"><\/span>Prosecutors rope Pfizer into fast-growing copay assistance probe<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>After first focusing on biotech and speciality pharma, the feds have made their way to Big Pharma, with the New York drug giant joining a group that includes Gilead Sciences, Biogen, Valeant Pharmaceuticals and others about ties to copay assistance programs. Such patient assistance programs have come under fire lately, with critics arguing pharma companies use them to boost sales. Governmental regulations prohibit drugmakers from linking their charitable contributions to their own meds, and drug companies aren&#8217;t allowed to offer direct co-pay assistance to patients covered by Medicare or Medicaid. Before Pfizer, Regeneron was the latest to disclose a subpoena in the government\u2019s growing probe.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Pharma_groups_to_FDA_Stop_that_new_off-label_rule_in_its_tracks\"><\/span>Pharma groups to FDA: Stop that new off-label rule in its tracks<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Cheered by victories in off-label marketing lawsuits, pharma companies were expecting some loosening of the regulatory shackles when the FDA rolled out a new rule on the subject. But that rule, published in the Federal Register last month, sent drugmakers into a minor tizzy\u2014and industry groups are demanding that the FDA set its new off-label regime aside. In a citizen petition filed earlier this month, and recently posted to the agency\u2019s website, the industry groups PhRMA and BIO and the Medical Information Working Group called on the FDA to stay the new rule and instead use a standard proposed in September 2015.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Regeneron_simulates_retinal_disease_with_virtual_and_augmented_reality_app\"><\/span>Regeneron simulates retinal disease with virtual and augmented reality app<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Together with Intouch Solutions, Regeneron Pharmaceuticals has created a virtual and augmented reality app called \u201cIn My Eyes\u201d that allows viewers to experience the blurriness, wavy lines or black patches caused by different types of retinal disease. The app can be used with or without VR goggles and works in two modes. In story mode, viewers look around a doctor\u2019s office in full 360 degrees and see three patients waiting. Choosing any patient will open up that person\u2019s story along with a video from their life, like a birthday party or picnic, shown through their specific retinal eye disease view. The three diseases featured are neovascular age-related macular degeneration\u00a0or wet AMD; diabetic macular edema\u00a0or DME; and macular edema following retinal vein occlusion, or MEfRVO. The second view is live mode, which engages the phone\u2019s camera to allow viewers to see whatever is in their field of vision through the three different retinal conditions.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Otsuka_and_Lundbeck_revive_Rexulti_mask_campaign_as_US_uptake_soars\"><\/span>Otsuka and Lundbeck revive Rexulti mask campaign as U.S. uptake soars<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The Pfizer fill-finish plant whose manufacturing problems have gut-punched the expected approval of a generic of Teva\u2019s long-acting Copaxone is a former Hospira plant with a history of issues. Execs at Momenta, which is developing the generic drug with Sandoz, said this week that they think an approval is still possible this year, but at least one researcher that has taken a deep dive into the Form 483 issued to the plant says he will be surprised if the issues can be resolved before late next year. The FDA issued a warning letter last week to the McPherson, Kansas, plant which is handling the fill and finish of Glatopa for Momenta and Sandoz. The facility already produces their 20-mg version, which was approved in 2015, and which Pfizer says is unaffected by the warning letter. The more valuable long-lasting 40-mg dose was expected to be approved this quarter.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Former_Valeant_Philidor_execs_plead_not_guilty_to_multimillion-dollar_fraud_and_kickback_charges\"><\/span>Former Valeant, Philidor execs plead not guilty to multimillion-dollar fraud and kickback charges<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The former Valeant and Philidor execs accused of engineering a multimillion-dollar fraud and kickback scheme deny the charges. Former Valeant senior director Gary Tanner and former CEO of now-dead specialty pharmacy Philidor, Andrew Davenport, pleaded not guilty to charges from federal prosecutors. The pair was indicted on four counts, including conspiracy to commit wire fraud and conspiracy to commit money laundering. According to the FBI special agent handling the investigation, Tanner received $10 million in kickbacks issued by Davenport that were &#8220;laundered through a series of shell companies and transactions designed to conceal the illicit payments,\u201d DOJ documents said.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Prosecutors rope Pfizer into fast-growing copay assistance probe After first focusing on biotech and speciality pharma, the feds have made their way to Big Pharma, with the New York drug giant joining a group that includes Gilead Sciences, Biogen, Valeant Pharmaceuticals and others about ties to copay assistance programs. Such patient assistance programs have come [&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":[134,704,1544,17470,460,712,479,1510],"industry":[17225],"therapeutic_areas":[17244],"class_list":["post-1923","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-business-consultant","tag-fda","tag-lundbeck","tag-otsuka","tag-pfizer","tag-pharma-industry","tag-pipeline-coverage","tag-regeneron-pharmaceuticals","industry-pharmaceutical","therapeutic_areas-ophthalmology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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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\">Business Consultant<\/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\">Lundbeck<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Otsuka<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pfizer<\/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\">Pipeline coverage<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Regeneron Pharmaceuticals<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Business Consultant<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Lundbeck<\/span>","<span class=\"advgb-post-tax-term\">Otsuka<\/span>","<span class=\"advgb-post-tax-term\">Pfizer<\/span>","<span class=\"advgb-post-tax-term\">Pharma Industry<\/span>","<span class=\"advgb-post-tax-term\">Pipeline coverage<\/span>","<span class=\"advgb-post-tax-term\">Regeneron Pharmaceuticals<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Feb 28, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Feb 28, 2017 12:02 pm","modified":"Updated on Jul 24, 2021 12:56 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