FDA Approves Ibrexafungerp for Vaginal Yeast Infection

▫️The US Food And Drug Administration (FDA) Has Approved Ibrexafungerp Tablets (Brexafemme) As A 1-day Oral Therapy For Vaginal Yeast Infections, Something 3 Out of Every 4 Women Encounter At Least Once In Their Life.
▫️Ibrexafungerp Is The First Drug Approved In A New Antifungal Class for The Condition, formally Known As Vulvovaginal Candidiasis (VVC), In More Than 20 Years, The Drug's Manufacturer Scynexis Said In A Press Release. It Becomes The First And Only Non-Azole Treatment for Vaginal Yeast Infections.
▫️The Biotechnology Company Said Approval Came After Positive Results from Two Phase 3 Studies In Which Oral Ibrexafungerp Demonstrated Efficacy And Tolerability. The Most Common Reactions Observed In Clinical Trials Were Diarrhea, Nausea, Abdominal Pain, Dizziness, And Vomiting.
▫️The New Drug May Not Fill That Need for Pregnant Women, However, As The Company Notes Ibrexafungerp Should Not Be Used During Pregnancy, And Administration During Pregnancy "May Cause Fetal Harm Based On Animal Studies."
▫️Because of Possible Teratogenic Effects, The Company Advises Clinicians To Verify Pregnancy Status In Females of Reproductive Potential Before Prescribing Ibrexafungerp And Advises Effective Contraception During Treatment.

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Preliminary Analysis of Association Between mRNA Vaccines And Sudden Hearing Loss

▫️In A New Study, Johns Hopkins Medicine Researchers Have Tried To Address Recent Reports That Sudden Sensorineural Hearing Loss - A Condition That Occurs As A Result of Damage To The Inner Ear - Has Been Suspected of Being A Potential Side Effect of Vaccination Against SARS-CoV-2, The Virus That Causes Covid-19.
▫️Out of More Than 86.5 Million Vaccine doses Administered During The Study Period, The Researchers Identified 40 Cases of Sensorineural Hearing Loss (SSNHL) That Appeared "Most Likely" To Be Linked To Vaccination Because They Had A Temporal Association, Occurring Within Three Weeks of Receipt of SARS-CoV-2 mRNA Vaccines, and were reported and documented by a healthcare clinician.
▫️Because VAERS Data Is Unverified, The Authors Performed A Sensitivity Analysis And Came Up With A Minimum Incidence Rate of 0.3 Per 100,000 Per Year, And A Maximum Incidence of 4.1 Per 100,000 Per Year.
- That Is Still Lower Than The Known Population Incidence of SSNHL, Which Ranges from Roughly 11 To 77 Per 100,000 Depending on Age Group, They Note In JAMA Otolaryngology-Head & Neck Surgery.

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Sinovac’s Covid-19 Vaccine Gains China Nod for Emergency Use In Kids, Adolescents

▫️China Has Approved Emergency Use of Sinovac Biotech’s Covid-19 Vaccine In People Aged Between Three And 17, Its Chairman Yin Weidong Told State TV Late on Friday.
▫️China's Mass Vaccination Drive, Which Administered 723.5 Million doses of Vaccines As of June 3, Is Currently Only Open To Those Aged 18 And Above.
▫️Preliminary Results From Phase I And II Clinical Trials Showed The Vaccine Could Trigger Immune Response In Three To 17 Year-Old Participants, And Most Adverse Reactions Were Mild.
▫️State-Backed Drugmaker Sinopharm, Which Has Two Shots Using Similar Technology To Sinovac's Product, Is Also Submitting Data For Clearance In Younger Groups. A Vaccine from CanSino Biologics', Adopting A Different Technique, Has Entered A Phase II Trial Involving Those Aged Between Six And 17.

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New Antibody Drug Keeps Mild Covid-19 From Worsening

▫️An Antibody Drug from Vir Biotechnology And GlaxoSmithKline That Protects Against Progression of Covid-19 In High-Risk Patients With Mild To Moderate Disease Has Received Emergency Use Authorization by The U.S. Food And Drug Administration (FDA).
▫️In A Large Randomized Trial, Patient Risk of Progression To More Severe illness Was Reduced by 85% With The Drug, Sotrovimab, Compared To A Placebo, According To An Interim Report from The Trial Posted on The medRxiv Website In Advance of Peer Review.
▫️Sotrovimab, The Antibody Treatment, Is Not Authorized For Patients Who Are Hospitalized Due To Covid-19 Or Require Oxygen Therapy, According To The Agency.
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Study: Nasal Therapy Is More Effective Than Commonly Used IgG Antibodies At Neutralizing Covid-19 Virus

▫️A Nasal Therapy, Built Upon on The Application of A New Engineered IgM Antibody Therapy for Covid-19, Was More Effective Than Commonly Used IgG Antibodies At Neutralizing The Covid-19 Virus In Animal Models, According To Research Recently Published by The University of Texas Health Science Center At Houston, The University of Texas Medical Branch At Galveston, The University of Houston, And IGM Biosciences, Inc.
▫️The Study Was Published In Nature.
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FDA Approved Novo Nordisk's Once-Weekly Semaglutide For Weight Loss

▫️The U.S. Food And Drug Administration (FDA) Has Approved Once-weekly Semaglutide Injection for Chronic Weight Management In Adults With Obesity Or With Overweight And At Least One Weight-Related Condition, According To An Agency Press Release.
▫️Weekly Semaglutide 2.4 mg (Wegovy, Novo Nordisk), A GLP-1 Receptor Agonist, Is The First-Approved Drug For Chronic Weight Management In Adults With General Obesity Or Overweight Since 2014.
▫️Semaglutide Is Indicated For Chronic Weight Management In Adults With A BMI of 27 kg/m² Or Greater Who Have At Least One Weight-Related Comorbidity, Such As Type 2 Diabetes Or Hypertension, Or In Adults With A BMI Of At Least 30 kg/m².

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New Non-Invasive Test Can Detect Bladder Cancer

▫️A Novel Urine Screening Test That Uses A Protein, Keratin 17 (K17), As A Cancer Biomarker Reveals The Test Detects The Presence of New Or Recurrent Cases of Bladder Cancer.
▫️A Study That Details The Finding of The Test Will Be Published In The American Journal of Clinical Pathology.
▫️Accurate Detection Of Bladder Cancer, Or Urothelial Carcinoma (UC), Is Often Difficult, Expensive And Involves Invasive Testing. Going Forward, This New Method, Based on The Detection of K17 In Urine Specimens, Could Help Guide Treatment By Improving Diagnostic Accuracy.
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A Novel Tuberculosis Regimen Shortens Treatment Course For Patients

▫️A Research Team Led by A Medical University of South Carolina (MUSC) Investigator Reports In The May 6 Issue of The New England Journal of Medicine That A Four-Month Treatment Regimen Using Rifapentine Is Effective for Treating Tuberculosis (TB).
▫️The Current Treatment for Those With An Active TB Infection Is A Multidrug Regimen Over The Course of Six To Nine Months.
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Mental Health Effects Common Among Mild And Severe Cases of Covid-19

▫️In A Study Published In The Journal of Neurology, Neurosurgery, And Psychiatry, Have Reported That Neurological And Psychiatric Symptoms Are Common Among People With Covid-19 And Maybe Just As Likely In People With Mild Cases.
▫️The Researchers Conducted A Meta-Analysis of 215 Covid-19-Related Studies Using Data Up To July 2020 from 30 Countries And Encompassing 105,638 People With Acute Symptoms of Covid-19.
▫️Across The Whole Dataset, The Most Common Neurological And Psychiatric Symptoms Were A Loss of Smell; Reported by 43% of Patients With Covid-19, Weakness (40%), Fatigue (38%), Loss of Taste; (37%), Myalgia (Muscle Pain; 25%), Depression (23%), Headache (21%) And Anxiety (16%).
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Heterologous Oxford And Pfizer Covid-19 Vaccines Induce Strong Immune Response And T Cell Reactivity Against Multiple SARS-CoV-2 Variants

▫️Researchers From Germany Recently Analyzed A Cohort of 26 Individuals In The Age Range of 25 to 46 (Median 30.5) Years Who Had Received A ChAdOx1 nCoV-19 (Vaxzevria, Oxford-AstraZeneca) Prime Vaccine Followed by A BNT162b2 (Comirnaty, BioNTech-Pfizer) Boost Vaccine After A 56-day Interval Due To Changing Vaccine Recommendations In Germany.
▫️There Were 16 Females And 10 Males In The Cohort, And They Were Assessed For Immune Responses, Reactogenicity, And T Cell Reactivity. This Study is Published on The medRxiv PrePrint Server.
▫️The Results Show That, Neutralizing Activity Against The UK Variant B.1.1.7 In Individuals Receiving Heterologous Vaccination Was 3.9-Fold Greater Than That In Individuals Receiving Homologous BNT162b2 Vaccination.
▫️Neutralizing Activity Was 2-Fold Reduced for The South African Variant B.1.351 And Was Similar for The B.1.617 Variant.
▫️To Summarize, The Heterologous ChAdOx1 nCoV-19 - BNT162b2 Prime-Boost Vaccination Regimen Did Not Cause Serious Adverse Events And Elicited A Potent Humoral Immune Response And T Cell Reactivity.
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US FDA ‌Approves Biogen's Alzheimer's Disease Drug Aducanumab

▫️U.S. Food And Drug Administration (FDA) On Monday Approved Biogen Inc's Aducanumab As The First Treatment To Address An Underlying Cause of Alzheimer's Disease Despite Controversy Over Mixed Clinical Trial Results for The Drug.
▫️Aducanumab Aims To Remove Sticky Deposits of A Protein Called Amyloid Beta From The Brains of Patients In Earlier Stages of Alzheimer's In Order To Stave off Its Ravages, Which Include Memory Loss And The Ability To Care for One's Self.
▫️The FDA Said Clinical Trials For The Treatment, To Be Sold Under The Brand Name Aduhelm, Showed A Reduction In The Plaques That Is Expected To Lead To A Reduction In The Clinical Decline of Patients.
▫️Aducanumab Was Studied In Patients With Early Disease Who Test Positive for A Component of Amyloid Brain Plaques. Some Trial Patients Experienced Potentially Dangerous Brain Swelling.

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Single BioNTech-Pfizer Vaccine dose Reduces Risk of Covid-19 By Nearly 52%

▫️Data Gathered From Real-World Vaccination Programs Following A Single dose of Pfizer Vaccine Administration Shows A Reduction of 51.4% In Infection Risk And Effectiveness of 54.4% Against Symptomatic Covid-19, Matching Clinical Trial Results.
▫️Data Was Gathered from 503 875 Individuals Who Received 1 dose of The Pfizer Vaccine, With Over Half Providing Follow-up Data for The Following 3 Weeks on The Incidence of SARS-CoV-2 Infection. 
▫️This Was Investigated by A Team of Researchers In Israel from The Maccabi Institute for Research & Innovation As Well As The Department of Epidemiology And Preventive Medicine of Tel Aviv University.

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FDA Authorizes Regeneron’s Covid-19 Antibody Therapy For Injection

▫️The U.S. Food And Drug Administration (FDA) Authorized A Lower dose of Regeneron Pharmaceutical’s Covid-19 Antibody Cocktail That Can Be Given By Injection, A Move That Could Ease Logistical Challenges Stemming from Administering A Higher dose Intravenously.
▫️The Therapy, REGEN-COV, And A Similar Treatment Developed by Rival Eli Lilly Were Being Given Through One-Time Infusion And Required Patients To Be Isolated.
▫️Regeneron Had Been Working On A Lower dose of Its Cocktail That Can Be Given Subcutaneously To Address The Challenges That Have Weighed on Demand for Antibody Drugs.
▫️The FDA Had In November Authorized a 2,400 mg dose of REGEN-COV, Administered As A Single dose Directly Injected To A Vein for Non-Hospitalized Covid-19 Patients.
▫️The Agency Has Now Lowered It To 1,200 mg And Allowed The Administration of Casirivimab And Imdevimab by Injecting Under The Skin When Intravenous Infusion Is Not Possible And Would Lead To Treatment Delay, Regeneron Said on Friday.

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CDC: Heart Inflammation Cases In Ages 16-24 Higher Than Expected After mRNA Covid-19 Shots

▫️Preliminary Findings From Two Vaccine Safety Monitoring Systems Suggest A Higher Than Expected Number of Cases Of Heart Inflammation After The Second dose of mRNA Covid-19 Vaccines In 16 To 24 Year Olds, The U.S. Centers for Disease Control And Prevention (CDC) Said on Thursday.
▫️The CDC Said In A Presentation Here Prepared for An Advisory Committee To The U.S. Food And Drug Administration (FDA) That Is Meeting on Thursday.
▫️Since April 2021, There Have Been Increased Reports To The Vaccine Adverse Event Reporting System (VAERS) of Cases of Inflammation of The Heart - Called Myocarditis And Pericarditis - Happening After mRNA Covid-19 Vaccination (Pfizer-BioNTech And Moderna) In The United States.

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Local Anesthetic Procaine Inhibits SARS-CoV-2 In Vitro

▫️Research Posted To The BioRxiv Preprint Server Has Shown That Procaine And Procaine-Hydrochloride Can Reduce Replication of SARS-CoV-2 And Influenza A Viruses In Infected Cells And Reduce The Production of Cytokines by The Viruses, Making Them Potentially Useful for Treating Covid-19.
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Heart inflammation In Young Men Higher Than Expected After Pfizer, Moderna Covid-19 Vaccines: U.S. CDC

▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases After Israel’s Health Ministry Reported That It Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
▫️More Than Half of The Cases Reported To The U.S. Vaccine Adverse Event Reporting System (VAERS) After People Had Received Their Second dose of Either The Pfizer-BioNTech Or Moderna Vaccines Were In People Between The Ages of 16 And 24, The CDC Said. Those Age Groups Accounted for Less Than 9% of doses Administered.
▫️The Agency Said It Is Still Assessing The Risk from The Condition And Has Not Yet Concluded That There Was A Causal Relationship Between The Vaccines And Cases of Myocarditis Or Pericarditis.
▫️There Were 283 Observed Cases of Heart Inflammation After The Second Vaccine dose In Those Aged 16 to 24 In The VAERS Data. That Compares With Expectations of 10 To 102 Cases For That Age Range Based on U.S. Population Background Incidence Rates, The CDC Said.
▫️The Median Age of Patients Who Experienced The Inflammation After A Second Vaccine dose Was 24, According To The VAERS Data. Just Under 80% of The Cases Were In Men.

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Drug Commonly Used As Antidepressant Helps Fight Cancer In Mice

▫️A Class of Drug Called Monoamine Oxidase Inhibitors Is Commonly Prescribed To Treat Depression; The Medications Work by Boosting Levels of Serotonin, The Brain's "Happiness Hormone."
▫️A New Study by UCLA Researchers Suggests That Those Drugs, Commonly Known As MAOIs, Might Have Another Health Benefit: Helping The Immune System Attack Cancer.
▫️Their Findings Are Reported In Two Papers, Which Are Published in The Journals Science Immunology And Nature Communications.
▫️Immune Cells That Had Infiltrated Tumors Had Much Higher Activity of A Gene Called Monoamine Oxidase A, Or MAOA.
- MAOA's Corresponding Protein, Called MAO-A, Controls Levels of Serotonin And Is Targeted by MAOI Drugs.
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Study Identifies How Covid-19 Linked To Alzheimer's Disease-Like Cognitive Impairment

▫️A New Cleveland Clinic-led Study Has Identified Mechanisms by Which Covid-19 Can Lead To Alzheimer's Disease-Like Dementia.
▫️The Findings, Published In Alzheimer's Research & Therapy, Indicate An Overlap Between Covid-19 And Brain Changes Common In Alzheimer's, And May Help Inform Risk Management And Therapeutic Strategies for Covid-19 Associated Cognitive Impairment.
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Metformin Prevents Pulmonary Or Lung Inflammation In Animals Infected With SARS-CoV-2

▫️In A Study Published Online June 8, 2021 In The Journal Immunity, A Multi-Institution Team Led by Researchers At University of California San Diego School of Medicine Identified The Molecular Mechanism for The Anti-Inflammatory Activity of Metformin And, In Mouse Studies, Found That Metformin Prevents Pulmonary Or Lung Inflammation In Animals Infected With SARS-CoV-2, The Virus That Causes Covid-19.
▫️Metformin Also Produced A Marked Reduction In Mortality In Endotoxin-Challenged Mice And Inhibited IL-1β Production And Inflammasome Assembly Within Alveolar Macrophages - Immune Cells Found In The Lungs.
▫️IL-1β, Along With IL-6, Are Small Proteins Called Cytokines That Cause Inflammation As An Early Immune Response. Their Amounts Are Often Highly Elevated In Persons Infected by SARS-CoV-2, Creating "Cytokine Storms" In Which The Body Starts Attacking Its Own Cells And Tissues.
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Vertex’s Trikafta Gets FDA Approval To Treat Cystic Fibrosis In Children

▫️Vertex Pharmaceuticals Has Secured The US Food And Drug Administration (FDA) Approval For Its Trikafta Drug To Treat Cystic Fibrosis In Children Aged Six To 11 Years.
▫️The Approval Is For Children With A Minimum of One F508del Mutation In The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Or A Mutation In The CFTR Gene That Responds To The Drug Based on In Vitro Data.
▫️Trikafta Is A Combination of Elexacaftor, Tezacaftor And Ivacaftor. With The Latest Approval, A New Dosage Strength of The Drug Is Available, The Company Noted.
▫️In 2019, Trikafta Received The FDA Nod For Use In Cystic Fibrosis Patients Aged 12 Years And Above. It Also Holds Approvals In Other Countries, Including Australia, The UK And The EU.

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Glenmark Reports Positive Data of Favipiravir In Covid-19 PMS Study

▫️Glenmark Pharmaceuticals Has Reported Interim Data from Its Post-Marketing Surveillance (PMS) Study In India Where No New Safety Signals Were Observed With Favipiravir Use In Mild-To-Moderate Covid-19 Patients.
▫️Interim Results from 503 Subjects Showed Two-Third of Participants Achieved Clinical Cure on Day Seven.
▫️Favipiravir, Which Holds Approval In Japan Since 2014 To Treat New Or Re-emerging Influenza Virus Infections, Is Marketed Under The Brand Name FabiFlu In India.
▫️The Prospective, Open-Label, Multi-Centre, Single-Arm PMS Study Began In July Last Year And Enrolled A Total of 1,083 Subjects At 13 Centers.
▫️It Analyzed The Safety And Efficacy of Favipiravir In Subjects With Mild-To-Moderate Covid-19.
▫️This Is The First And Large PMS Trial Being Carried Out In The Country To Assess Favipiravir In This Patient Population, Glenmark Noted.
▫️Previously Established Side Effects, Including Weakness, Gastritis, Diarrhoea And Vomiting, Were Observed To Be Mild.

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