Initially, Fox had actually stood out from the MAGA pack by suggesting the incumbent president was doomed when its Decision Desk called Arizona for Joe Biden. It’s about connecting the dots.”Īfter the 2020 election, Dominion’s suit contents, Fox News viewers were abandoning it for fringe outlets like Newsmax that were willing to indulge the most dangerous and deluded claims about why Donald Trump lost. “Dominion has to show that the people who were responsible for creating (or platforming) the false statements about Dominion had knowledge that those statements were false. “It isn’t enough to show that Fox made a conscious decision to amplify election denialism generally in its coverage,” said RonNell Andersen Jones, a former newspaper reporter who is now a First Amendment expert at the University of Utah. The company will put Fox’s key decision-makers on the stand and ask 12 jurors to assess their state of mind in November and December 2020. What Dominion must prove now is a tougher legal challenge. That Fox’s allegations about Dominion were dead false has already been decided - they were, according to Judge Eric Davis, who is presiding over the case in Delaware Superior Court. It was a craven bid for profit, Dominion says, and the myth it fueled ultimately led to the insurrection at the U.S. Sources: Evaluate Pharma & company releases.Dominion, which makes voting machines, is accusing the conservative network of knowingly spreading disinformation about its products in the days after the 2020 election to appease an audience hungry for conspiracy theories. Reducing risk of preterm birth in women who have a history of singleton spontaneous preterm birth Withdrawn, confirmatory data insufficient to support conversion to full approval (Shine did not show OS Selene did not meet PFS) Previously untreated mantle cell lymphoma ( Shine) and relapsed or refractory marginal zone lymphoma ( Selene) Treatment of critically ill adult Covid-19 patients ( Panamo) Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy Mdc-IRM (Uzedy) (risperidone extended-release) Thyroid eye disease regardless of thyroid eye disease activity or duration (ph4 NCT04583735) Primary immunodeficiency in children aged 2-16 Growth hormone deficiency in children up to 11 years old ( Real4) Preventative treatment of chronic migraine ( Progress) Pneumococcal vaccine in infants & children 6 weeks to 17 years old (ph3 NCT04382326, NCT04546425, NCT04379713, Ph2) Supplementary and other notable approval decisions in April 2023ġL urothelial cancer cisplatin ineligible patients (Ph1b/2 EV-103/Keynote-869 dose escalation/cohort A & cohort K) Sources: Evaluate Pharma, FDA adcom calendar & company releases. *Already on the market in different treatment line. Hospital‐acquired and ventilator‐associated bacterial pneumonia caused by A cinetobacter baumannii‐calcoaceticus complex in adults Sulbactam-durlobactam for injection (Sul-Dur) Lynparza + Zytiga + prednisone/prednisoloneġst-line castration-resistant prostate cancer ( Propel)ġ1-1 vote to restrict label to Brca+ve patients (Pdufa had been expected in March)Īgitation associated with Alzheimer’s dementia Sources: Evaluate Pharma & company releases.Īdvisory committee meetings in April 2023 Treatment of schizophrenia and maintenance treatment of bipolar I disorder Quizartinib (Vanflyta) + standard cytarabine and anthracycline inductionĬell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantationĪpproved (extended Pdufa had been expected 1 May)ĪLS associated with a mutation in Sod1 gene Notable first-time US approval decisions in April 2023ĭeficiencies identified in NDA, then CRL (manufacturing issues) Attention now turns to the EU, where the EMA gave Lynparza a broad prostate cancer label at the end of last year. In addition, a panel to discuss Lynparza’s use in first-line prostate cancer voted to restrict the label to Brca-positive patients, based on data from the Propel study. Elsewhere manufacturing issues scuppered Ascendis’s TransCon PTH, intended to treat hypoparathyroidism, and Lilly’s mirikizumab in ulcerative colitis. Stifel analysts highlighted the broader readthrough to the neurology division's openness to biomarkers, noting Sarepta’s closely watched panel this month for the Duchenne muscular dystrophy gene therapy SRP-9001. The accelerated decision was based on a neurofilament biomarker, and the ongoing Atlas trial in pre-symptomatic carriers will serve as the confirmatory study. Biogen and Ionis’s Qalsody is already backed by a positive panel, and received a US greenlight last month in ALS patients with Sod1 mutations.
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