{"id":2061,"date":"2017-04-18T12:17:19","date_gmt":"2017-04-18T12:17:19","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2061"},"modified":"2021-07-24T12:56:44","modified_gmt":"2021-07-24T07:26:44","slug":"notizia-35","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-35","title":{"rendered":"Novartis gets CAR-T drug; Shire aims to block; Xeljanz stands; Payer snubs; Lawmakers pass a bill"},"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-69f58d595c9de\" 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-69f58d595c9de\"  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-35\/#Novartis_gets_second_CAR-T_candidate_FDA_%E2%80%98breakthrough_tag\" >Novartis gets second CAR-T candidate FDA \u2018breakthrough\u2019 tag<\/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-35\/#Shire_armed_with_new_rare_disease_patent_aims_to_block_CSLs_Haegarda_launch\" >Shire, armed with new rare disease patent, aims to block CSL&#8217;s Haegarda launch<\/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-35\/#Pfizers_Xeljanz_stands_to_win_from_Lillys_baricitinib_stunner\" >Pfizer&#8217;s Xeljanz stands to win from Lilly&#8217;s baricitinib stunner<\/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-35\/#Payer_snubs_PTCs_Emflaza_signaling_pricing_trouble_ahead_of_launch\" >Payer snubs PTC&#8217;s Emflaza, signaling pricing trouble ahead of launch<\/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-35\/#Maryland_lawmakers_pass_a_bill_aimed_at_stopping_%E2%80%98unconscionable_drug_pricing\" >Maryland lawmakers pass a bill aimed at stopping &#8216;unconscionable&#8217; drug pricing<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_gets_second_CAR-T_candidate_FDA_%E2%80%98breakthrough_tag\"><\/span>Novartis gets second CAR-T candidate FDA \u2018breakthrough\u2019 tag<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA \u2018breakthrough\u2019 tag for its eagerly awaited JULIET trial. This latest label, which can speed things along for Novartis\u2019 CTL019 (tisagenlecleucel), is for relapsed\/refractory (r\/r) diffuse large B-cell lymphoma (DLBCL). This is the most common form of lymphoma and accounts for around 30% of all non-Hodgkin lymphoma cases. The drug already has a breakthrough tag for r\/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients, and was given a priority review at the end of March. Novartis is in a race with Kite Pharma, a specialist CAR-T biotech working on axicabtagene ciloleucel (a.k.a. KTE-C19), which a day after Novartis got its priority review, said it had finished its rolling submission with the FDA for a BLA of its med as a treatment for patients with r\/r B-cell non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Shire_armed_with_new_rare_disease_patent_aims_to_block_CSLs_Haegarda_launch\"><\/span>Shire, armed with new rare disease patent, aims to block CSL&#8217;s Haegarda launch<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Anticipating an FDA approval later this year for a promising hereditary angioedema med from CSL, Shire has taken a preemptive strike at the Australian drugmaker. In a new lawsuit, it\u2019s asking a court to block the launch. Filed last week in U.S. District Court in Delaware, Shire\u2019s lawsuit contends that CSL is gearing up to launch a drug, Haegarda, that will step on its own brand-new patent, issued just last week. Shire&#8217;s attempt to block the launch follows Amgen&#8217;s successful bid for an injunction against Sanofi and Regeneron, which make Praluent, a PCSK9 cholesterol drug that rivals its own Repatha. That injunction, if upheld on appeal, would push Praluent off the market, unless the two sides agree on royalties. It would be the first such move against a rival drug in almost a decade.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Pfizers_Xeljanz_stands_to_win_from_Lillys_baricitinib_stunner\"><\/span>Pfizer&#8217;s Xeljanz stands to win from Lilly&#8217;s baricitinib stunner<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Eli Lilly &amp; Co.\u2019s Olumiant rejection surprise Friday has one obvious beneficiary: Pfizer and its rival rheumatoid arthritis med, Xeljanz, already set to break the blockbuster barrier this year. That\u2019s because Xeljanz is the sole oral JAK inhibitor now FDA-approved for rheumatoid arthritis. Olumiant (baricitinib) would have been the second, and some analysts predicted the Lilly med\u2014licensed from Incyte for $90 million up front, plus milestones and marketing arrangements\u2014might beat Xeljanz on the efficacy side. Baricitinib had been pegged as one of 2017&#8217;s biggest launches. Now, Olumiant isn\u2019t likely to roll out for a couple more years, giving Xeljanz more time to solidify its first-to-market lead.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Payer_snubs_PTCs_Emflaza_signaling_pricing_trouble_ahead_of_launch\"><\/span>Payer snubs PTC&#8217;s Emflaza, signaling pricing trouble ahead of launch<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">PTC Therapeutics faces an uphill battle to extract brand-level pricing and sales with its new, and controversial, DMD drug Emflaza if a new policy report out of Washington state is any indication of payer sentiments. Washington State\u2019s Health Care Authority, the largest purchaser in the state, published a review of the newly approved med compared to the much cheaper prednisone, currently the most commonly used steroid by Duchenne muscular disorder patients. Emflaza, a decades-old steroid itself, recently won FDA approval under Marathon Pharma\u2019s ownership. But that drugmaker\u2019s decision to attach an $89,000 price tag to a med that\u2019s available elsewhere for much cheaper created instant backlash.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Maryland_lawmakers_pass_a_bill_aimed_at_stopping_%E2%80%98unconscionable_drug_pricing\"><\/span>Maryland lawmakers pass a bill aimed at stopping &#8216;unconscionable&#8217; drug pricing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Taking the fight against high drug prices into their own hands, Maryland lawmakers passed a bill aimed at taking on \u201cunconscionable\u201d pricing practices with their sights set squarely on generics. But drug makers are blasting back, hoping to convince the governor not to sign it into law. Under the legislation, the Maryland Medical Assistance Program will notify Attorney General Brian Frosh if a generic drug\u2019s price spikes by 50% in one year or if its price increases while there are three or fewer companies making the med, among other potential violations. Then, the attorney general is able to request a report from drug makers detailing production costs, the rationale for the price hike and efforts to expand access. If Frosh determines the company committed a violation of the pricing law, he can request that a circuit court force it to roll back the price hike and return money to consumers.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis gets second CAR-T candidate FDA \u2018breakthrough\u2019 tag As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA \u2018breakthrough\u2019 tag for its eagerly awaited JULIET trial. This latest label, which can speed [&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":[810,17512,17511,1270,17510,853,423,460,639,852],"industry":[17225],"therapeutic_areas":[17235,17227,17228],"class_list":["post-2061","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-car-t","tag-car-t-drug","tag-emflaza","tag-hereditary-angioedema","tag-jak-inhibitor","tag-maryland-medical-assistance","tag-novartis","tag-pfizer","tag-pharma-news","tag-shire","industry-pharmaceutical","therapeutic_areas-cell-and-gene-therapy","therapeutic_areas-immunological-and-autoimmune-disorders","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\">CAR-T<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">CAR-T Drug<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Emflaza<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Hereditary Angioedema<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">JAK inhibitor<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Maryland Medical Assistance<\/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\">Pfizer<\/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\">Shire<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">CAR-T<\/span>","<span class=\"advgb-post-tax-term\">CAR-T Drug<\/span>","<span class=\"advgb-post-tax-term\">Emflaza<\/span>","<span class=\"advgb-post-tax-term\">Hereditary Angioedema<\/span>","<span class=\"advgb-post-tax-term\">JAK inhibitor<\/span>","<span class=\"advgb-post-tax-term\">Maryland Medical Assistance<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Pfizer<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">Shire<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Apr 18, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Apr 18, 2017 12:17 pm","modified":"Updated on Jul 24, 2021 12:56 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