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Welcome to this special edition of the Neurology News Network. My name is Marco Meglio.
Recently, the FDA and the Centers for Disease Control and Prevention (CDC) released a joint statement evaluating data related to the bivalent COVID-19 vaccine from Pfizer and Biontech that increases the risk of ischemic stroke in older adults. I claimed. “CDC’s Vaccine Safety Data Link (VSD), a near-real-time surveillance system, meets statistical criteria, raising concerns about ischemic stroke safety in people aged 65 and older who have had Pfizer BioNTech COVID-19. It has prompted additional investigation as to whether the vaccine is bivalent,” the CDC/FDA statement read. “VSD signal rapid response study reveals that people aged 65 and older who received the Pfizer-Biontech COVID-19 vaccine, Bivalent, were more likely to have an ischemic stroke within 21 days after vaccination than 1 day.” 22-42 after vaccination.” The CDC website notes that agencies use a variety of surveillance systems to detect potential safety signals in vaccines. We will investigate further if necessary. “These safety systems often detect signals that may be due to factors other than the vaccine itself,” the website read.
Using data from the United Kingdom Biobank (UKB), a recently published study found an association between antiepileptic drug (AED) prescription use and accidental Parkinson’s disease (PD) diagnosis. These findings were consistent with previous reports of an association between epilepsy and PD. Data extracted in June 2021 showed an association between AED use and incident PD, as explained by an OR of 1.80. Specifically, sodium valproate showed the highest OR, followed by levetiracetam, lamotrigine, and carbamazepine. Odds of incident PD were higher in individuals who were prescribed more than one of his AEDs and in individuals with a high number of problems.
After Showing Positive Results in a Phase 3 Clinical Program, FDA Grants Revance Therapeutic Additional New Biologics Approval for Daxibotulinutoxin A Injection (Daxxify) as a New Treatment for Adult Cervical Dystonia Your application (sBLA) has been accepted. The agency has scheduled August 19, 2023 as her PDUFA treatment date. To date, this therapy has shown promising results in his two phase 3 trials, ASPEN-1 and ASPEN-OLS, in cervical dystonia. In ASPEN-1, both the 125 unit and 250 unit dose groups of daxibotulinum toxin A showed clinically meaningful improvements in signs and symptoms of cervical dystonia on average by weeks 4 and 6. achieved its primary endpoint. In a controlled parallel-group study, the 125-unit and 250-unit treatment groups improved by 12.7 and 10.9 points, respectively, on the Toronto Western Spastic Torticollis Rating Scale (TWSTRS) versus the placebo group, which recorded a change of 4.3. was shown.
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