{"id":16685,"date":"2022-03-22T18:57:22","date_gmt":"2022-03-22T13:27:22","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=16685"},"modified":"2022-03-22T19:08:29","modified_gmt":"2022-03-22T13:38:29","slug":"pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris","title":{"rendered":"Bristol Myers\u2019 Opdivo combo Opdualag for Melanoma; Biogen\u2019s Aduhelm; Marinus\u2019 Ztalmy for CDKL-5 Deficiency Disorder; Merck\u2019s Keytruda + Lynparza; Vitaris\u2019s Breyna; Moderna\u2019s Second COVID-19 Booster Shot; Takeda\u2019s Exkivity; BMS\u2019s First LAG-3 Checkpoint Inhibitor"},"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-69fe674b92843\" 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-69fe674b92843\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#NHS_Grants_Fast_Track_Access_to_Takedas_Exkivity\" >NHS Grants Fast Track Access to Takeda\u2019s Exkivity<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#FDA_Clears_BMSs_First_LAG-3_Checkpoint_Inhibitor\" >FDA Clears BMS\u2019s First LAG-3 Checkpoint Inhibitor<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#FDA_Approves_Bristol_Myers_Opdivo_combo_Opdualag_for_Melanoma\" >FDA Approves Bristol Myers\u2019 Opdivo combo Opdualag for Melanoma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#Biogen_Publishes_Phase_3_Aduhelm_Data\" >Biogen Publishes Phase 3 Aduhelm Data<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#Vitaris_Wins_FDA_Approval_for_First_Generic_of_AstraZenecas_Symbicort\" >Vitaris Wins FDA Approval for First Generic of AstraZeneca\u2019s Symbicort<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#Moderna_Seeks_FDA_Approval_for_Second_COVID-19_Booster_Shot\" >Moderna Seeks FDA Approval for Second COVID-19 Booster Shot<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#FDA_Approves_Marinus_Ztalmy_for_CDKL-5_Deficiency_Disorder\" >FDA Approves Marinus\u2019 Ztalmy for CDKL-5 Deficiency Disorder<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\/#Mercks_Keytruda_Lynparza_Combo_Trial_Fails_for_Prostate_Cancer\" >Merck\u2019s Keytruda + Lynparza Combo Trial Fails for Prostate Cancer<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"NHS_Grants_Fast_Track_Access_to_Takedas_Exkivity\"><\/span><strong>NHS Grants Fast Track Access to Takeda\u2019s Exkivity<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Takeda <\/strong>has secured UK approval for its lung cancer therapy <strong>Exkivity<\/strong>, with an NHS access deal that could see it prescribed to patients within the next few weeks.<\/p>\n\n\n\n<p>The <strong>Medicines and Healthcare products Regulatory Agency<\/strong> has granted conditional marketing authorisation to Exkivity as monotherapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-epidemiology-forecast\"><strong>non-small-cell lung cancer<\/strong> patients<\/a>.<\/p>\n\n\n\n<p>At the same time, <strong>NHS England<\/strong>, cost-effectiveness watchdog <strong>NICE <\/strong>and <strong>Takeda <\/strong>have agreed on an early access deal for the drug that includes a discount on its monthly cost of around <strong>$25,000<\/strong>.<\/p>\n\n\n\n<p>According to Sajid Javid, <strong>Secretary of Health and Social Care<\/strong>, <strong>Exkivity <\/strong>will be available to eligible patients in England \u201con a budget-neutral basis to the NHS while NICE completes its ongoing appraisal\u201d.<\/p>\n\n\n\n<p>It is expected that around <strong>100 people<\/strong> per year in England will be eligible for the treatment with the drug, the first oral therapy specifically designed for people with <strong>NSCLC<\/strong>.<\/p>\n\n\n\n<p>Another drug targeting the <strong>EGFR exon20 mutation<\/strong> \u2013 <strong>Johnson &amp; Johnson\u2019s Rybrevant (amivantamab)<\/strong> \u2013 is under regulatory review by the <strong>MHRA <\/strong>and <strong>NICE <\/strong>but is administered by<strong> intravenous infusion<\/strong>.<\/p>\n\n\n\n<p>\u201cTrials demonstrate that some patients who have taken mobocertinib have lived for approximately two years after being treated with the breakthrough drug, which is significantly longer than expected for patients with this type of lung cancer,\u201d said NHS England.<\/p>\n\n\n\n<p><strong>Exon 20 insertions<\/strong> are seen in approximately <strong>10%<\/strong> of patients who present with <strong>EGFR mutations<\/strong> and <strong>2%<\/strong> of <strong>NSCLC <\/strong>patients overall.<\/p>\n\n\n\n<p>NHS national medical director Prof Stephen Powis said that patients in England will be the first in Europe to get access to Exkivity \u2013 at an affordable price for the taxpayer \u2013 \u201cthanks to another deal struck by the NHS.\u201d<\/p>\n\n\n\n<p>Earlier examples include deals for <strong>Amgen\u2019s <\/strong>first-in-class <strong>KRAS inhibitor Lumykras <\/strong>(<strong>sotorasib<\/strong>) for <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/kras-mutant-cancer-pipeline-insight\">KRAS-mutated non-small cell lung cancer<\/a><\/strong>,<strong> Novartis\u2019 <\/strong>cholesterol-lowering<strong> Leqvio (inclisiran)<\/strong> that can be dosed once every six months, and <strong>AstraZeneca\u2019s Tagrisso (osimertinib) <\/strong>for <strong>non-small cell lung cancer with EGFR exon 19 or exon 21 mutations<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Clears_BMSs_First_LAG-3_Checkpoint_Inhibitor\"><\/span><strong>FDA Clears BMS\u2019s First LAG-3 Checkpoint Inhibitor<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol-Myers Squibb<\/strong> has won <strong>FDA approval<\/strong> for the first<strong> LAG-3 inhibitor <\/strong>drug ahead of its competitors in <a href=\"https:\/\/www.delveinsight.com\/report-store\/chimeric-antigen-receptor-macrophage-car-m-immunotherapy-pipeline-insight\">cancer immunotherapy<\/a>, including <strong>Merck &amp; Co.<\/strong><\/p>\n\n\n\n<p>The <strong>US regulator cleared Bristol-Myers Squibb\u2019s LAG-3 drug relatlimab<\/strong> as a fixed-dose combination with its <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/pd-1-inhibitor-pipeline-insight\">PD-1 inhibitor Opdivo (nivolumab)<\/a><\/strong> \u2013 under the brand name, <strong>Opdualag <\/strong>\u2013 in patients aged 12 or over suffering from <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/untreated-metastatic-or-unresectable-melanoma-pipeline-insight\">unresectable\/metastatic melanoma<\/a><\/strong>.<\/p>\n\n\n\n<p>The company has brought the antibody to market ahead of Merck\u2019s <strong>favezelimab<\/strong>, which is being developed as a combination with <strong>PD-1 inhibitor Keytruda<\/strong> and started a <strong>phase III <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/colorectal-cancer-crc-market\"><strong>clinical trial<\/strong> in <strong>colorectal cancer<\/strong><\/a> last year.<\/p>\n\n\n\n<p>Like <strong>PD-1, LAG-3<\/strong> is a negative regulator of T-cells, suppressing their activity against cancer cells, so when that brake is released, the immune system can attack and kill tumors.<\/p>\n\n\n\n<p>The FDA approved <strong>Opdualag <\/strong>on the strength of the <strong>phase 2\/3 RELATIVITY-047 trial <\/strong>in <strong>unresectable\/metastatic melanoma<\/strong>, which demonstrated that patients on the combination drug had a median progression-free survival of <strong>10.1 months<\/strong>, versus <strong>4.6 months<\/strong> for <strong>Opdivo<\/strong> alone.<\/p>\n\n\n\n<p>Safety-wise, no new signals or types of clinically essential events were identified with the fixed-dose combination therapy compared with Opdivo monotherapy.<\/p>\n\n\n\n<p>However, there were more grade <strong>3\/4 drug-related adverse events<\/strong>, coming in at <strong>18.9%<\/strong> in the combination arm compared to <strong>9.7%<\/strong> with <strong>Opdivo<\/strong>, and discontinuation rates were <strong>14.6% <\/strong>and <strong>6.7%<\/strong>, respectively.<\/p>\n\n\n\n<p>The results nevertheless make <strong>Opdualag <\/strong>an alternative to <strong>Opdivo <\/strong>plus <strong>Yervoy (ipilimumab)<\/strong> \u2013 BMS\u2019 notoriously hard to tolerate <strong>CTLA4 checkpoint inhibitor<\/strong> \u2013 which has been approved as a <strong>monotherapy <\/strong>for <strong>melanoma <\/strong>since <strong>2011 <\/strong>and as <strong>dual therapy <\/strong>with <strong>Opdivo <\/strong>since <strong>2015<\/strong>.<\/p>\n\n\n\n<p>In trials, more than <strong>50%<\/strong> of melanoma patients treated with <strong>Yervoy<\/strong> had grade <strong>3\/4 side effects<\/strong>, although the top-line efficacy of the <strong>Opdivo\/Yervoy<\/strong> combination looks a little better than <strong>Opdualag<\/strong>.<\/p>\n\n\n\n<p>Despite its safety issues, <strong>Yervoy<\/strong> is a <strong>$2 billion<\/strong> product for BMS, so there is a risk that <strong>relatlimab <\/strong>could start to cannibalize some of those revenues. However, the <strong>CTLA4 inhibitor<\/strong> is approved alongside <strong>Opdivo <\/strong>for several other cancers.<\/p>\n\n\n\n<p>That includes <strong>renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer (NSCLC) and mesothelioma<\/strong>. It\u2019s worth noting also that Yervoy is not too far away from patent expiry, so <strong>Opdualag <\/strong>will help bolster BMS\u2019 cancer immunotherapy franchise once biosimilar rivals reach the market.<\/p>\n\n\n\n<p>BMS has high expectations for Opdualag, saying previously it expects sales to reach <strong>$4 billion<\/strong> before the end of the decade. Still, it remains to be seen how the combination fares in other tumor types, with trials on the go in lung and colorectal cancers.<\/p>\n\n\n\n<p>The company told <strong>Reuters <\/strong>it expects the drug will cost <strong>$27,389 per infusion<\/strong> after discounts. That is roughly in the same ballpark as the <strong>Opdivo\/Yervoy<\/strong> combination for <strong>melanoma<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-bristol-myers-opdivo-combo-opdualag-for-melanoma\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Bristol_Myers_Opdivo_combo_Opdualag_for_Melanoma\"><\/span><strong>FDA Approves Bristol Myers\u2019 Opdivo combo Opdualag for Melanoma<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol-Myers Squibb<\/strong> has established the third cancer checkpoint inhibitor class, returning to its immuno-oncology roots in melanoma with an FDA approval. The new drug, <strong>relatlimab<\/strong>, a LAG-3 antibody, has been approved in a fixed-dose combination with <strong>BMS&#8217; PD-1 inhibitor Opdivo<\/strong> for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-melanoma-market\">treatment of unresectable or metastatic Melanoma<\/a>. The product will be marketed under the brand name Opdualag. With this approval, BMS now has three checkpoint inhibitors on the market, including its <strong>CTLA-4 blocker Yervoy<\/strong>. All three drugs were approved for the first time in Melanoma, as was the duo immunotherapy cocktail <strong>Opdivo and Yervoy.<\/strong><\/p>\n\n\n\n<p><strong>Opdualag <\/strong>was approved based on data demonstrating that it can double the amount of time patients with previously untreated advanced Melanoma can live without disease progression when compared to Opdivo alone. Patients on the fixed-dose combo had a median progression-free survival of <strong>10.1 months<\/strong> in <strong>Phase 3 RELATIVITY-047 trial<\/strong>, compared to <strong>4.6 months<\/strong> for Opdivo alone.<\/p>\n\n\n\n<p>According to BMS, approximately one-third of advanced melanoma patients are currently treated with PD-1 monotherapy, including <strong>Merck &amp; Co.&#8217;s Keytruda<\/strong>. A third are receiving <strong>Opdivo-plus-Yervoy,<\/strong> while the remaining third, primarily those with BRAF mutations, are receiving targeted therapies such as Novartis&#8217; Tafinlar and Mekinist.<\/p>\n\n\n\n<p>The <strong>relatlimab-Opdivo<\/strong> combination is an important component of BMS&#8217; plan to overcome the patent protection losses of three of its top-selling drugs\u2014blood cancer therapy <a href=\"https:\/\/www.delveinsight.com\/report-store\/revlimid-api-insights\"><strong>Revlimid<\/strong><\/a>, <strong>Pfizer<\/strong>-shared blood thinner <strong>Eliquis<\/strong>, and <strong>Opdivo<\/strong>\u2014within a decade. According to the company, the new partnership could generate more than <strong>USD 4 billion<\/strong> in sales by 2029.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Biogen_Publishes_Phase_3_Aduhelm_Data\"><\/span><strong>Biogen Publishes Phase 3 Aduhelm Data<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Biogen <\/strong>has disclosed the results of its <strong>Phase 3 clinical trials<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/blog\/alzheimers-disease-market\"><strong>Alzheimer&#8217;s<\/strong> drug <strong>Aduhelm<\/strong><\/a> in a peer-reviewed journal, allowing clinicians to analyse the data and assess its efficacy and safety after months of discussion over its validity.<\/p>\n\n\n\n<p>On the other hand, the choice of the journal appears to be adding to the controversy surrounding the troubled drug, which has only been used to treat a few patients since the FDA granted its accelerated approval last June.<\/p>\n\n\n\n<p>The paper on the results of <strong>Phase 3 ENGAGE and EMERGE trials<\/strong> was published in the <strong>Journal of Prevention of Alzheimer&#8217;s Disease (JPAD)<\/strong>, a fairly well-established journal with less prestige than one might expect for featuring the first drug claimed to be disease-modifying in Alzheimer&#8217;s.<\/p>\n\n\n\n<p><strong>EMERGE<\/strong>, as previously reported, demonstrated a statistically significant change across primary and secondary clinical endpoints, including the <strong>Clinical Dementia Rating Sum of Boxes (CDR-SB)<\/strong> at week 78, whereas <strong>ENGAGE <\/strong>failed across the board.<\/p>\n\n\n\n<p>The FDA eventually approved Aduhelm based on the reduction in amyloid-beta plaques observed in patients treated with the drug, a surrogate marker associated with cognitive effects that Biogen associates with the drug.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vitaris_Wins_FDA_Approval_for_First_Generic_of_AstraZenecas_Symbicort\"><\/span><strong>Vitaris Wins FDA Approval for First Generic of AstraZeneca\u2019s Symbicort<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Viatris <\/strong>announce the <strong>FDA <\/strong>approval for the first generic of <strong>AstraZeneca\u2019s Symbicort (budesonide and formoterol fumarate dihydrate)<\/strong> Inhalation Aerosol, <strong>Breyna&#x2122; <\/strong>to <a href=\"https:\/\/www.delveinsight.com\/report-store\/asthma-market\"><strong>treat Asthma<\/strong><\/a><strong> <\/strong>and <strong>Chronic Obstructive Pulmonary Disease (COPD)<\/strong>. Breyna is a drug-device combination product consisting of a metered-dose inhaler, developed by Viatris in collaboration with 3M spin-off company <strong>Kindeva Drug Delivery.<\/strong> The drug is not to be used to treat acute asthma attacks, the FDA said. Symbicort generated <strong>$2.7 billion<\/strong> in revenue from global sales for <strong>AstraZeneca <\/strong>last year, while the sales were nearly around <strong>$1 billion<\/strong> from the <a href=\"https:\/\/www.delveinsight.com\/report-store\/us-healthcare-outlook-report\"><strong>US healthcare market<\/strong><\/a>.<\/p>\n\n\n\n<p>Breyna is being approved for asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-obstructive-pulmonary-disease-copd-market\"><strong>patients with chronic obstructive pulmonary disease (COPD)<\/strong><\/a>, including chronic <strong>bronchitis <\/strong>and\/or <strong>emphysema<\/strong>.<\/p>\n\n\n\n<p><strong>In 2018<\/strong>, <strong>AstraZeneca <\/strong>sued <strong>Viatris&#8217; Mylan Pharmaceuticals<\/strong> for alleged infringement. In March 2021, a district court ruled in favour of AstraZeneca. Later back in December 2021, the U.S. Court of Appeals for the Federal Circuit changed the infringement decision and transmitted the case back down to the lower court for more proceedings. Viatris is looking forward to launching <strong>Breyna <\/strong>in 2022, subject to the upcoming court proceedings development.<\/p>\n\n\n\n<p>Currently, the <a href=\"https:\/\/www.delveinsight.com\/report-store\/asthma-pipeline-insight\">drug treatments for asthma<\/a> in the market include long-term control treatments, such as inhaled corticosteroids, long-acting beta-agonists, and oral medications. The approval of Breyna provides high hope for many patients living with these two common pulmonary health conditions. As per the WHO, globally, Asthma affects nearly <strong>260 million people<\/strong> and caused around <strong>461000 deaths<\/strong> in 2019. In the<strong> United States<\/strong>, approximately <strong>25 million<\/strong> <a href=\"https:\/\/www.delveinsight.com\/report-store\/asthma-epidemiology-forecast\">people are affected with asthma<\/a>, which is equal to about 1 in 13 Americans and includes 8 per cent of adults and 7 per cent of children (which is more than five million). Similarly, according to DelveInsight\u2019s estimates, <strong>COPD <\/strong>has a higher diagnosed prevalence in the United States with 17,455,600+ <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-obstructive-pulmonary-disease-copd-epidemiology-forecast\">diagnosed cases of COPD<\/a> in 2020, which is expected to increase in the coming years.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Moderna_Seeks_FDA_Approval_for_Second_COVID-19_Booster_Shot\"><\/span><strong>Moderna Seeks FDA Approval for Second COVID-19 Booster Shot<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest updates in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-coronavirus-pipeline-insights\">COVID-19 vaccine development<\/a>, the Biotechnology giant <strong>Moderna <\/strong>has requested the <strong>FDA <\/strong>to grant emergency authorisation for a second booster shot of its <strong>COVID-19 vaccine<\/strong> covering all adults over 18 who\u2019ve received approved vaccines. It is an <a href=\"https:\/\/www.delveinsight.com\/report-store\/global-messenger-rna-mrna-based-vaccines-and-therapeutics-market\"><strong>mRNA vaccine<\/strong><\/a> that can provide higher immune protection. Moderna is seeking approval for the booster shot based on the recent data from Israel and the US, following the emergence of the omicron variant. Moderna&#8217;s first booster shot was authorised for emergency use in November 2021. Currently, Moderna&#8217;s first booster is administered after a month of its two doses of primary vaccines.<\/p>\n\n\n\n<p>Earlier, the other major players in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape\">COVID-19 therapeutics segment<\/a>, <strong>Pfizer <\/strong>and its partner <strong>BioNTech <\/strong>also requested authorisation for a second booster shot. However, the overall coverage of the population is smaller as it will be available for people aged 65 &amp; older and who\u2019ve been vaccinated. Additionally, both Moderna and Pfizer are also evaluating omicron-specific booster shots, the data for which is expected to release in the coming days.<\/p>\n\n\n\n<p>Currently, countries like <strong>Israel <\/strong>have started administering the fourth dose to adults. The booster shots applications by pharma and biotech companies have raised several questions regarding how long vaccines are capable to protect from infection. Will people require to take repeated shots to generate infection-fighting antibodies and prevent severe disease and death?&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Marinus_Ztalmy_for_CDKL-5_Deficiency_Disorder\"><\/span><strong>FDA Approves Marinus\u2019 Ztalmy for CDKL-5 Deficiency Disorder<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The recent FDA approval of <strong>Ztalmy (ganaxolone)<\/strong> developed by <strong>Marinus Pharmaceuticals,<\/strong> comes as the first and only FDA-approved treatment therapy for seizures associated with <a href=\"https:\/\/www.delveinsight.com\/infographics\/cyclin-dependent-kinase-like-5-cdkl5-deficiency-disorder-market\"><strong>CDKL5 (cyclin-dependent kinase-like 5) deficiency disorder (CDD)<\/strong><\/a> &#8211; a rare form of genetic epilepsy, in patients of two years of age and older. An oral suspension, the first FDA approved treatment for this specific CDD, is considered to be a neuroactive steroid that serves as a positive allosteric modulator of the <strong>GABAA receptor.&nbsp;<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/cyclin-dependent-kinase-like-5-deficiency-disorder-pipeline-insight\">CDD<\/a> is a very rare as well as serious genetic disorder that can be characterized by early\u2011onset and difficult\u2011to\u2011control seizures. The cause of this disorder is mutation of the <a href=\"https:\/\/www.delveinsight.com\/report-store\/cyclin-dependent-kinase-like-5-cdkl5-deficiency-disorder-market\">cyclin-dependent kinase-like 5 (CDKL5)<\/a> gene, situated on the X chromosome. The CDKL5 gene generates a protein necessary for normal brain function and development. The approval from the US regulatory was done on the basis of results from a<strong> Phase 3 Marigold, double-blind, placebo-controlled trial<\/strong>, where<strong> 101 participants<\/strong> who went under the study, were randomized and individually treated with ZTALMY. The participants indicated that Ztalmy significantly reduced major motor seizure frequency in CDD patients in the pivotal Marigold trial.<\/p>\n\n\n\n<p>Some of the common side effects that were observed through the study included somnolence, fever, salivary hypersecretion, and seasonal allergy. ZTALMY is anticipated to be launched and commercially available in the U.S. from July following the schedule by the U.S. Drug Enforcement Administration.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Mercks_Keytruda_Lynparza_Combo_Trial_Fails_for_Prostate_Cancer\"><\/span><strong>Merck\u2019s Keytruda + Lynparza Combo Trial Fails for Prostate Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck &amp; Co\u2019s <\/strong>and <strong>AstraZeneca\u2019s<\/strong> two blockbuster oncology drugs namely <strong>Keytruda <\/strong>and <a href=\"https:\/\/www.delveinsight.com\/report-store\/lynparza-api-insights\"><strong>Lynparza<\/strong><\/a> have both given disappointing results and failed to show efficacy when delivered to patients in combination with previously treated <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-market\"><strong>metastatic castration-resistant prostate cancer (mCRPC)<\/strong><\/a>. The results were taken from the <strong>KEYLYNK-010 trial<\/strong>, which included a combination of PD-1 inhibitor Keytruda (pembrolizumab) with AstraZeneca-partnered PARP inhibitor Lynparza (olaparib) in prostate cancer men whose cancer progressed after chemotherapy and anti-androgen therapy.<\/p>\n\n\n\n<p>The study was done to compare Keytruda\/Lynparza treatment to that of anti-androgen therapy with either Pfizer\/Astellas <a href=\"https:\/\/www.delveinsight.com\/report-store\/xtandi-api-insights\">Xtandi (enzalutamide)<\/a> or Johnson &amp; Johnson\u2019s <a href=\"https:\/\/www.delveinsight.com\/report-store\/zytiga-api-insights\">Zytiga (abiraterone)<\/a>, but eventually was found with no improvements, whether in&nbsp; interim analyses on <strong>radiographic progression-free survival (rPFS) <\/strong>or for<strong> overall survival (OS).<\/strong><\/p>\n\n\n\n<p>The study outcomes are considered to be a rare setback for both <a href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-abbvie-sandoz-incyte-bayer-venatorx\">Keytruda and Lynparza<\/a>, as they are already seen as extremely efficacious drugs in their respective classes. Lynparza is approved as a second-line treatment for<strong> homologous recombination repair (HRR) gene-mutated mCRPC<\/strong>, whereas Keytruda is struggling to make an impact in prostate cancer treatment. This disease is nowhere to be seen in the long list of approved indications for Keytruda.<br>On the other hand, Merck and AZ are still running clinical trials for better outcomes of the drug combinations in treatment of other cancer forms such as <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-pipeline-insight\">lung cancer<\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/ovarian-cancer-pipeline-insight\">ovarian cancer<\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/triple-negative-breast-cancer-tnbc-pipeline-insight\">triple-negative breast cancer (TNBC).<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>NHS Grants Fast Track Access to Takeda\u2019s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisation to Exkivity as monotherapy for non-small-cell lung [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":16692,"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":[72,1875,19179,718,10830,349,394,19178,420,1111,639,498,19177],"industry":[17225],"therapeutic_areas":[17229,17238,17231,17245,17228,17243],"class_list":["post-16685","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alzheimers-disease","tag-asthma","tag-cdkl5","tag-copd","tag-covid-19","tag-latest-pharma-news","tag-melanoma","tag-mrna-vaccine","tag-news","tag-nsclc","tag-pharma-news","tag-prostate-cancer","tag-untreated-metastatic-or-unresectable-melanoma","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-genetic-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-respiratory-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>Pharma News and Updates | BMS, Biogen, Merck, Vitaris, Takeda, Marinus<\/title>\n<meta name=\"description\" content=\"Bristol Myers\u2019 Opdivo; Biogen\u2019s Aduhelm; Marinus\u2019 Ztalmy; Merck\u2019s Keytruda + Lynparza; Vitaris\u2019s Breyna; Takeda\u2019s Exkivity; Moderna\u2019s Covid19\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-biogen-marinus-merck-takeda-vitaris\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News and Updates | BMS, Biogen, Merck, Vitaris, Takeda, Marinus\" \/>\n<meta property=\"og:description\" content=\"Bristol Myers\u2019 Opdivo; Biogen\u2019s 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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\">Alzheimer\u2019s disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">asthma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">CDKL5<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COPD<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COVID-19<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma news<\/a>","<a 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