{"id":2150,"date":"2017-05-30T17:00:35","date_gmt":"2017-05-30T11:30:35","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2150"},"modified":"2021-07-24T12:56:46","modified_gmt":"2021-07-24T07:26:46","slug":"notizia-41","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-41","title":{"rendered":"Roche, Boehringer tout; Pfizer, Bristol-Myers got sued; FDA commissioner unveils; EpicGenetics expands"},"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-69ffc21075002\" 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-69ffc21075002\"  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-41\/#Roche_Boehringer_tout_new_idiopathic_pulmonary_fibrosis_analyses_to_boost_their_rival_medications\" >Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications<\/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-41\/#Trio_of_patients_sue_Pfizer_Bristol-Myers_claiming_they_soft-pedaled_Eliquis_bleeding_risks\" >Trio of patients sue Pfizer, Bristol-Myers, claiming they soft-pedaled Eliquis bleeding risks<\/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-41\/#New_FDA_commissioner_Gottlieb_unveils_price-fighting_strategies\" >New FDA commissioner Gottlieb unveils price-fighting strategies<\/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-41\/#EpicGenetics_looks_north_to_expand_landmark_fibromyalgia_study\" >EpicGenetics looks north to expand landmark fibromyalgia study<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Roche_Boehringer_tout_new_idiopathic_pulmonary_fibrosis_analyses_to_boost_their_rival_medications\"><\/span>Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche\u2019s Esbriet and Boehringer Ingelheim\u2019s Ofev hasn\u2019t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmakers upped the ante with positive new data for their contenders. At the American Thoracic Society\u2019s annual meeting, Roche rolled out new analyses of phase 3 data showing that Esbriet, when compared with placebo, could cut the risk of death by 72% among patients with more serious lung function impairment, reduce patient-reported breathlessness among sufferers with moderate impairment and decrease the rate of respiratory-related hospitalizations among patients. Competitor Boehringer, though, had good news to report from new analyses of it own. Pooled phase 3 data showed that Ofev patients were, at 36.8%, twice as likely as those on placebo to experience an improvement\u2014or experience no decline\u2014in lung function, the German pharma said. Results also showed that Ofev didn\u2019t increase the incidence of major adverse cardiovascular events among high-risk patients when compared with placebo. Both drug makers are looking for an edge in what so far has proved to be a competitive market race.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Trio_of_patients_sue_Pfizer_Bristol-Myers_claiming_they_soft-pedaled_Eliquis_bleeding_risks\"><\/span>Trio of patients sue Pfizer, Bristol-Myers, claiming they soft-pedaled Eliquis bleeding risks<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Just two weeks after convincing a judge in New York to toss a liability case over Eliquis bleeding risks, Pfizer and Bristol-Myers Squibb face three new suits in the same state over claims their big-selling anticoagulant ended up hurting patients. Filed this week in New York State court, the suits say Pfizer and BMS \u201cnegligently and fraudulently\u201d represented their blockbuster med as \u201csafe and effective for its indicated uses.\u201d The companies \u201cconcealed their knowledge of Eliquis&#8217; defects\u201d from prescribing physicians and the larger public, the lawsuits claim. After several months on Eliquis, the plaintiffs developed a variety of bleeding problems\u2014bilateral subdural hemorrhages in one case, a subdural hematoma in another and postoperative bleeding, acute blood loss anemia and a hematoma in the third, according to the lawsuits. All of them required lengthy hospital stays. Pfizer and BMS \u201cbelieve that the claims in these cases lack merit,\u201d according to a Pfizer spokesperson.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"New_FDA_commissioner_Gottlieb_unveils_price-fighting_strategies\"><\/span>New FDA commissioner Gottlieb unveils price-fighting strategies<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices. Importantly, the FDA can\u2019t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year. At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to \u201ccurtail gaming\u201d of regulations by the industry that allows companies to extend patent monopolies. In his opening remarks at the budget hearing, Gottlieb said he\u2019s working on a \u201cdrug competition action plan\u201d that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"EpicGenetics_looks_north_to_expand_landmark_fibromyalgia_study\"><\/span>EpicGenetics looks north to expand landmark fibromyalgia study<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">For four years, EpicGenetics has been selling its diagnostic for fibromyalgia in the U.S. Now it can list Canada among its international markets for the test. The company says approval and launch in Canada will help it push forward with an ambitious R&amp;D program that is trying to decipher the underlying genetic basis for the chronic and painful condition, which affects millions of people worldwide. The Santa Monica, California, company made waves when its FM\/a blood test for fibromyalgia secured a CLIA certification and became the first test available for fibromyalgia, which often goes undiagnosed because its symptoms can be so diverse. Aside from pain it can be accompanied by fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche\u2019s Esbriet and Boehringer Ingelheim\u2019s Ofev hasn\u2019t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmakers upped the ante with positive new data for their contenders. At [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1534,"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":[119,784,17529,913,17530,651,420,730,460,464,524,595],"industry":[17225],"therapeutic_areas":[17227,17241],"class_list":["post-2150","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-biotech","tag-bms","tag-eliquis","tag-epicgenetics","tag-fibromyalgia","tag-idiopathic-pulmonary-fibrosis","tag-news","tag-notizia","tag-pfizer","tag-pharma","tag-roche","tag-usfda","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-musculoskeletal"],"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\">Biotech<\/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\">Eliquis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">EpicGenetics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Fibromyalgia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Idiopathic Pulmonary Fibrosis<\/a>","<a 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class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Notizia<\/span>","<span class=\"advgb-post-tax-term\">Pfizer<\/span>","<span class=\"advgb-post-tax-term\">Pharma<\/span>","<span class=\"advgb-post-tax-term\">Roche<\/span>","<span class=\"advgb-post-tax-term\">USFDA<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on May 30, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on May 30, 2017 5:00 pm","modified":"Updated on Jul 24, 2021 12:56 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