\n \n \n Cabenuva Ad (ViiV Healthcare)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 12:39 PM EST<\/div>\n Pharma<\/span><\/a><\/div>Marketing<\/span><\/a><\/div>\n<\/div>\n \n GlaxoSmithKline\u2019s ViiV Healthcare aims to shift HIV daily pill thinking in first DTC ads<\/h2>\n \n \n <\/div>\n \n Beth Snyder Bulik<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n For as long as there have been HIV medicines, the only options for patients have been daily pills — until this year that is. GlaxoSmithKline’s ViiV Healthcare approval for long-acting injectable Cabenuva in January marked a sudden change.<\/p>\nInstead of people with HIV taking daily pills — a habit even reinforced in pop culture in film and other fictional depictions — there’s now a once-a-month injection option.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n Garo Armen, Agenus CEO (Wikimedia Commons)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 10:29 AM EST<\/div>\n R&D<\/span><\/a><\/div>\n<\/div>\n \n Spurned by FDA on another immunotherapy, Agenus holds up early data for CTLA-4 drug across tumor types<\/h2>\n \n \n <\/div>\n \n Kyle Blankenship<\/h3>\n Managing Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n In a Phase I study across nine tumor types, Agenus’ CTLA-4 drug AGN1181 posted one complete response and three partial responses as a monotherapy, offering a key efficacy baseline as the biotech pursues a combination strategy with in-house PD-(L)1 drug balstilimab, according to data presented Friday at SITC.<\/p>\nThree of those responders expressed the low affinity FcγRIIIA receptor, Agenus said, which is associated with a lack of response to first-generation CTLA-4 inhibitors. This Phase I study mostly enrolled heavily pretreated patients with more than half having undergone three or more prior lines of therapy and one-third having received a prior PD-(L)1.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 09:52 AM EST<\/div>\n R&D<\/span><\/a><\/div>\n<\/div>\n \n Novartis touts more late-stage data for inclisiran, the once-centerpiece heart drug spurned by the FDA<\/h2>\n \n \n <\/div>\n \n Nicole DeFeudis<\/h3>\n Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Novartis bet large on The Medicines Company’s RNAi heart drug inclisiran, expecting to shake up that segment of the market with a swift US approval. But after getting stiff-armed by the FDA last year, the pharma giant’s now releasing more post-hoc data in the hopes of finally running it past the goal line.<\/p>\nPatients who took inclisiran — or Leqvio, as it’s marketed in the EU — in three Phase III trials saw sustained reductions in bad cholesterol of about 50% compared to placebo at month 17, regardless of body mass index, Novartis announced<\/a> at this year’s American Heart Association virtual conference.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 02:08 PM EST<\/div>\n Pharma<\/span><\/a><\/div>Marketing<\/span><\/a><\/div>\n<\/div>\n \n The very slow roll of Biogen's Aduhelm: Neurologists weigh in on patients, practices and payments amid ongoing media storm<\/h2>\n \n \n <\/div>\n \n Beth Snyder Bulik<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Five months after the approval of Biogen’s Aduhelm, the bad news just keeps piling up for the Alzheimer’s drug. The confirmation yesterday of a Biogen investigation<\/a> into the death of trial participant is the latest setback, but it adds to a laundry list of ongoing woes including insurance reimbursement uncertainty<\/a>, dismal initial sales<\/a>, a label flipflop<\/a>, FDA advisory committee members resigning<\/a> and outspoken researchers and public officials who continue to question the drug’s approval.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n <\/span>\n <\/a>\n <\/a>\n <\/div>\n ENDPOINTS CAREERS<\/span><\/div>\n <\/div>\n \n \n <\/div>\n \n Director, Business Development<\/a><\/h3>\n Adicet Bio<\/h4>\n Menlo Park, CA, USA<\/h4>\n \n view job offer<\/a>\n post your job now<\/a>\n <\/div>\n <\/div>\n <\/div>\n\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n Garo Armen, Agenus CEO (Wikimedia Commons)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 10:29 AM EST<\/div>\n R&D<\/span><\/a><\/div>\n<\/div>\n \n Spurned by FDA on another immunotherapy, Agenus holds up early data for CTLA-4 drug across tumor types<\/h2>\n \n \n <\/div>\n \n Kyle Blankenship<\/h3>\n Managing Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n In a Phase I study across nine tumor types, Agenus’ CTLA-4 drug AGN1181 posted one complete response and three partial responses as a monotherapy, offering a key efficacy baseline as the biotech pursues a combination strategy with in-house PD-(L)1 drug balstilimab, according to data presented Friday at SITC.<\/p>\nThree of those responders expressed the low affinity FcγRIIIA receptor, Agenus said, which is associated with a lack of response to first-generation CTLA-4 inhibitors. This Phase I study mostly enrolled heavily pretreated patients with more than half having undergone three or more prior lines of therapy and one-third having received a prior PD-(L)1.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 09:52 AM EST<\/div>\n R&D<\/span><\/a><\/div>\n<\/div>\n \n Novartis touts more late-stage data for inclisiran, the once-centerpiece heart drug spurned by the FDA<\/h2>\n \n \n <\/div>\n \n Nicole DeFeudis<\/h3>\n Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Novartis bet large on The Medicines Company’s RNAi heart drug inclisiran, expecting to shake up that segment of the market with a swift US approval. But after getting stiff-armed by the FDA last year, the pharma giant’s now releasing more post-hoc data in the hopes of finally running it past the goal line.<\/p>\nPatients who took inclisiran — or Leqvio, as it’s marketed in the EU — in three Phase III trials saw sustained reductions in bad cholesterol of about 50% compared to placebo at month 17, regardless of body mass index, Novartis announced<\/a> at this year’s American Heart Association virtual conference.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 02:08 PM EST<\/div>\n Pharma<\/span><\/a><\/div>Marketing<\/span><\/a><\/div>\n<\/div>\n \n The very slow roll of Biogen's Aduhelm: Neurologists weigh in on patients, practices and payments amid ongoing media storm<\/h2>\n \n \n <\/div>\n \n Beth Snyder Bulik<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Five months after the approval of Biogen’s Aduhelm, the bad news just keeps piling up for the Alzheimer’s drug. The confirmation yesterday of a Biogen investigation<\/a> into the death of trial participant is the latest setback, but it adds to a laundry list of ongoing woes including insurance reimbursement uncertainty<\/a>, dismal initial sales<\/a>, a label flipflop<\/a>, FDA advisory committee members resigning<\/a> and outspoken researchers and public officials who continue to question the drug’s approval.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n <\/span>\n <\/a>\n <\/a>\n <\/div>\n ENDPOINTS CAREERS<\/span><\/div>\n <\/div>\n \n \n <\/div>\n \n Director, Business Development<\/a><\/h3>\n Adicet Bio<\/h4>\n Menlo Park, CA, USA<\/h4>\n \n view job offer<\/a>\n post your job now<\/a>\n <\/div>\n <\/div>\n <\/div>\n\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 12, 2021 09:52 AM EST<\/div>\n R&D<\/span><\/a><\/div>\n<\/div>\n \n Novartis touts more late-stage data for inclisiran, the once-centerpiece heart drug spurned by the FDA<\/h2>\n \n \n <\/div>\n \n Nicole DeFeudis<\/h3>\n Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Novartis bet large on The Medicines Company’s RNAi heart drug inclisiran, expecting to shake up that segment of the market with a swift US approval. But after getting stiff-armed by the FDA last year, the pharma giant’s now releasing more post-hoc data in the hopes of finally running it past the goal line.<\/p>\nPatients who took inclisiran — or Leqvio, as it’s marketed in the EU — in three Phase III trials saw sustained reductions in bad cholesterol of about 50% compared to placebo at month 17, regardless of body mass index, Novartis announced<\/a> at this year’s American Heart Association virtual conference.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 02:08 PM EST<\/div>\n Pharma<\/span><\/a><\/div>Marketing<\/span><\/a><\/div>\n<\/div>\n \n The very slow roll of Biogen's Aduhelm: Neurologists weigh in on patients, practices and payments amid ongoing media storm<\/h2>\n \n \n <\/div>\n \n Beth Snyder Bulik<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Five months after the approval of Biogen’s Aduhelm, the bad news just keeps piling up for the Alzheimer’s drug. The confirmation yesterday of a Biogen investigation<\/a> into the death of trial participant is the latest setback, but it adds to a laundry list of ongoing woes including insurance reimbursement uncertainty<\/a>, dismal initial sales<\/a>, a label flipflop<\/a>, FDA advisory committee members resigning<\/a> and outspoken researchers and public officials who continue to question the drug’s approval.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n <\/span>\n <\/a>\n <\/a>\n <\/div>\n ENDPOINTS CAREERS<\/span><\/div>\n <\/div>\n \n \n <\/div>\n \n Director, Business Development<\/a><\/h3>\n Adicet Bio<\/h4>\n Menlo Park, CA, USA<\/h4>\n \n view job offer<\/a>\n post your job now<\/a>\n <\/div>\n <\/div>\n <\/div>\n\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 02:08 PM EST<\/div>\n Pharma<\/span><\/a><\/div>Marketing<\/span><\/a><\/div>\n<\/div>\n \n The very slow roll of Biogen's Aduhelm: Neurologists weigh in on patients, practices and payments amid ongoing media storm<\/h2>\n \n \n <\/div>\n \n Beth Snyder Bulik<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Five months after the approval of Biogen’s Aduhelm, the bad news just keeps piling up for the Alzheimer’s drug. The confirmation yesterday of a Biogen investigation<\/a> into the death of trial participant is the latest setback, but it adds to a laundry list of ongoing woes including insurance reimbursement uncertainty<\/a>, dismal initial sales<\/a>, a label flipflop<\/a>, FDA advisory committee members resigning<\/a> and outspoken researchers and public officials who continue to question the drug’s approval.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n <\/span>\n <\/a>\n <\/a>\n <\/div>\n ENDPOINTS CAREERS<\/span><\/div>\n <\/div>\n \n \n <\/div>\n \n Director, Business Development<\/a><\/h3>\n Adicet Bio<\/h4>\n Menlo Park, CA, USA<\/h4>\n \n view job offer<\/a>\n post your job now<\/a>\n <\/div>\n <\/div>\n <\/div>\n\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n \n <\/span>\n <\/a>\n <\/a>\n <\/div>\n ENDPOINTS CAREERS<\/span><\/div>\n <\/div>\n \n \n <\/div>\n \n Director, Business Development<\/a><\/h3>\n Adicet Bio<\/h4>\n Menlo Park, CA, USA<\/h4>\n \n view job offer<\/a>\n post your job now<\/a>\n <\/div>\n <\/div>\n <\/div>\n\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 9, 2021 11:00 AM EST<\/div>\n Pharma<\/span><\/a><\/div>FDA+<\/span><\/a><\/div>\n<\/div>\n \n Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.<\/p>\nBut a new research letter published Tuesday in JAMA Network Open<\/em> raises fresh questions<\/a> about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 04:00 PM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Moderna disputes NIH claims on Covid-19 vaccine patents, says it offered to make government co-owners<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna on Thursday afternoon issued a quick rebuttal to recent NIH claims<\/a> on its Covid-19 vaccine patents, saying that the mRNA sequence for the vaccine was “selected exclusively by Moderna scientists using Moderna’s technology” and without input of three NIH scientists. The company also said that it attempted to name NIH as co-owners on the patent in September.<\/p>\n“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic,” the company said in a statement. NIH did not immediately respond to a request for comment.<\/p>\n\n \n Keep reading Endpoints with a free subscription<\/h3>\n Unlock this story instantly and join 123,100+ biopharma pros reading Endpoints daily — and it's free. <\/p>\n \n SIGN UP<\/button>\n LOG IN<\/button>\n <\/div>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article><\/div><\/section>\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n Paul Burton, Moderna CMO<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 10:59 AM EST<\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n Covid-19 roundup: Moderna notes higher myocarditis risk for young males when compared to Pfizer's vaccine; EMA signs off on Roche, Celltrion mAb treatments<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n Moderna’s new CMO Paul Burton spoke to reporters Thursday morning, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.<\/p>\nThe media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n
\n \n \n Francis Collins (Michael Reynolds\/Pool via AP Images)<\/span><\/div>\n<\/div>\n \n \n \n <\/span>\n \n <\/a>\n <\/a>\n \n <\/div>\n \n November 11, 2021 07:26 AM ESTUpdated 08:58 AM<\/span><\/div>\n Coronavirus<\/span><\/a><\/div>\n<\/div>\n \n NIH 'not done' fighting Moderna over Covid vaccine patents, director Francis Collins says<\/h2>\n \n \n <\/div>\n \n Zachary Brennan<\/h3>\n Senior Editor<\/h4>\n <\/div>\n<\/div>\n<\/div>\n \n \n \n The NIH is standing by its assertion that three of its scientists should be listed in the Moderna patent for the company’s lucrative Covid-19 vaccine.<\/p>\nThe spat is part of an ongoing feud between the US government and Moderna that spilled into public view last month when one of President Joe Biden’s top medical advisors called out the company<\/a> for failing to deliver on its promise to vaccinate more low- and middle-income countries.<\/p>\n\n\n Read More<\/button>\n<\/div>\n\n <\/div>\n <\/div>\n<\/article>\n \n \n