Eli Lilly To Seek Accelerated FDA Approval for Alzheimer's Drug This Year

▫️Eli Lilly And Co Said on Thursday It Will Apply For U.S. Health Regulator’s Accelerated Approval This Year for Its Experimental Alzheimer’s Drug, Weeks After Biogen Inc’s Controversial Drug For The Disease Was Approved.
▫️Like Aduhelm (Aducanumab), Lilly’s Dug Candidate, Donanemab, Too Is Designed To Remove Clumps of A Protein Called Beta Amyloid From The Brain. The Protein Is Believed To Be A Contributing Cause of Alzheimer’s.
▫️Lilly In January Said Early Results from A Mid-Stage Trial of 272 Patients Showed Donanemab Met Its Main Goal of Slowing The Rate of Decline In Cognition And Function In Patients At An Early Stage of The Mind-Wasting Disease.
▫️Results For The Trial’s Secondary Goals Measuring Cognition And Function Were Positive, But Not All of Them Reached Statistical Significance.
▫️Lilly Is Continuing To Study The Drug In A Late-Stage Study.
▫️The Company Said It Would File A Marketing Application for Donanemab Based on Data from The Mid-Stage Trial.
▫️The FDA on Thursday Granted Donanemab A Breakthrough Therapy Designation, Meant To Expedite The Development And Review of Medicines for Serious Or Life-Threatening Conditions.

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Gilead Reports Interim Late-Stage Data From Viral Hepatitis Drug Trial

▫️Gilead Sciences Has Reported Interim Data from Its Phase IIb And Phase III Clinical Trials, Which Showed Hepcludex (Bulevirtide) Provided A Substantial Response In Patients With Chronic Hepatitis Delta Virus (HDV).
▫️Hepcludex Is An Investigational Entry Inhibitor Agent In The Developmental Stage.
▫️According To Data from The Phase III MYR301 Trial, 36.7% of The HDV Patients Receiving Bulevirtide 2mg Had Combined Virological And Biochemical Response After 24 Weeks, Along With 28% of Those Who Were Given Bulevirtide 10mg.
▫️Bulevirtide 2mg Was Observed To Offer An Increased Response Rate As Against The 10mg dose In 24-Week Treatment.
▫️Gilead Noted That The Phase III Trial Results Support The Safety And Efficacy Profile of The Once-Daily dose of Bulevirtide 2mg.
▫️The Company Intends To Submit The Phase III Data of Bulevirtide To The US Food And Drug Administration (FDA) Later This Year.

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Novel mRNA Vaccine Provides Full Protection Against Malaria In Mice

▫️Scientists from The Walter Reed Army Institute of Research (WRAIR) And Naval Medical Research Center, Both US, Have Partnered With Researchers At The University of Pennsylvania and Acuitas Therapeutics To Develop A Novel Malaria Vaccine Based on mRNA Technology. The Researchers Found That The Vaccine Protects Against The Disease In Animal Models.
▫️According To The Team, The Most Advanced Malaria Vaccine Is RTS,S, Based on The Circumsporozoite Protein of Plasmodium Falciparum, The Most Dangerous And Widespread Species of Malaria Parasite.
▫️The Results of The Study Are Published In NPJ Vaccines.
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U.S. Pauses Distribution of Lilly's Covid-19 Antibody Combination Therapy

▫️U.S. Health Officials on Friday Paused The Distribution of Eli Lilly's Covid-19 Antibody Cocktail Therapy As It Failed To Show Effectiveness Against The Coronavirus Variants That Were First Identified In Brazil And South Africa.
▫️The Decision by The U.S. Department of Health And Human Services (HHS) Is Based on Laboratory Analyses That Showed Lilly's Dual-Antibody Therapy - Bamlanivimab And Etesevimab - Was Not Active Against Either Variant.
▫️The Centers for Disease Control and Prevention (CDC) Said The Gamma Variant, First Seen In Brazil, And The Beta Variant, First Found In South Africa, Together Made Up For More 11% of Infections In The United States And That The Number Is Growing.
▫️The U.S. Health Regulator in April Revoked The Emergency Use Authorization for Lilly's Bamlanivimab And Required It To Be Used Along With Etesevimab To Achieve Greater Effectiveness Against Emerging Variants.
▫️The HHS Also Said Regeneron's Antibody Therapy, REGEN-COV, And GlaxoSmithKline And Partner Vir Biotechnology's Sotrovimab Are Likely To Be Effective Against The Variants.

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Argentina Says Oxford-AstraZeneca, Sputnik V Single dose Cuts Mortality Up To 80%

▫️A Single dose of Russia's Sputnik V Or The Oxford University-AstraZeneca Vaccine Reduces Mortality from Covid-19 By Between 70% And 80% In People Aged 60-Plus, Real-World Data from Argentina's National Inoculation Program Show.
▫️The Preliminary Study Data, Released on Friday by The Country's Health Ministry, Involved Some 450,000 People Aged 60 Years of Age And Above Who Received One Or Two doses of Either Vaccine, Which Are The Most Widely Used In Argentina.
▫️"The First dose Generates Almost 80% Immunity, The Second, In General, Increases That Response And Makes It More Durable Over Time," Health Minister Carla Vizzotti Said In A Statement, Adding With A Second dose Mortality Decreased Around 90%.
▫️Argentina's Inoculation Campaign Has Been Built Around The Sputnik V And AstraZeneca Vaccines, As Well As Using Sinopharm And CoviShield Shots.

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Mix-And-Match Approach Boosts Immune Response of Oxford-AstraZeneca Shot, Study Finds

▫️A Mixed Schedule of Vaccines Where A Shot of Pfizer’s Covid-19 Vaccine Is Given Four Weeks After An Oxford-AstraZeneca Shot Will Produce Better Immune Responses Than Giving Another dose of AstraZeneca, An Oxford Study Said on Monday.
▫️The Study, Called Com-COV, Compared Mixed Two-dose Schedules of Pfizer And Oxford-AstraZeneca Vaccines, And Found That In Any Combination, They Produced High Concentrations of Antibodies Against The Coronavirus Spike Protein.
▫️The Data Provides Support for The Decision of Some European Countries That Have Started Offering Alternatives To AstraZeneca As A Second Shot.
▫️An AstraZeneca Shot Followed by Pfizer Produced The Best T-Cell Responses, And Also A Higher Antibody Response Than Pfizer Followed by AstraZeneca.
▫️The Results Were for Combinations of Vaccines Given At Four Week Intervals To 830 Participants.
▫️Com-COV Is Also Looking At Mixed Schedules Over A 12-Week Interval, And Noted That AstraZeneca’s Shot Was Known To Produce A Better Immune Response With A Longer Interval Between doses.

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Clinical Observations Show Acute Myocarditis Developed After mRNA Covid-19 Vaccination

▫️A New Clinical Report From The Duke Cardiovascular Magnetic Resonance Center In Durham, North Carolina, Shows Novel Cases of Acute Myocarditis Following mRNA Covid-19 Vaccination.
▫️The Report Follows Patients Suffering From Acute Myocarditis And Specifically Examined Patients That Had Been Vaccinated Prior To Hospitalization In North Carolina.
▫️4 of The 7 Patients That Showed Symptoms Post-Vaccination Were Aged Between 23 And 70 Years Old And Presented Severe Chest Pain As Well As Biomarker Evidence of Myocardial Injury.
▫️The Patients Were Hospitalized And Had Cardiac Magnetic Resonance Imaging Findings Typical of Myocarditis. The Diagnosis of Acute Myocarditis 5 Days After The Vaccination Suggests That Patients Experienced Symptoms As Potential Side Effects From Having The Vaccine Administered.
▫️The Study Appears Online In JAMA Cardiology.

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Molnupiravir: An Oral Antiviral Pill For Covid-19 Shows Promise

▫️Recently, Researchers At The University of North Carolina At Chapel Hill Reported Molnupiravir As The First Oral And Direct-Acting Antiviral That Is Highly Effective At Reducing Nasopharyngeal SARS-CoV-2 Infectious Virus And Viral Ribonucleic Acid (RNA) Levels.
▫️The Study, Which Appeared In The Pre-Print Server medRxiv, Demonstrates That Molnupiravir Has Favorable Safety And Tolerability Profiles, Thus Making It A Promising Antiviral Against SARS-CoV-2.
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Roche's Neuromyelitis Optica Drug "Enspryng" Wins EU Approval

▫️Roche’s Enspryng Has Been Approved by The European Commission, The Swiss Drugmaker Said on Monday, The Latest Regulatory Blessing for The Injectible Drug That Can Be Given At Home To Treat Neuromyelitis Optica Spectrum Disorder.
▫️The EU Approval Follows The U.S. Food And Drug Administration’s (FDA) Green Light Last August To Treat The Rare Condition, Also Called Devic’s Disease, Where The Immune System Damages The Spinal Cord And The Nerves of The Eyes.
▫️Three Drugs Have U.S. Approval For Treating The Disease, Including Enspryng, Alexion’s Soliris And Horizon Therapeutics’ Uplizna, In What Is One of The Healthcare World’s Most-Costly Treatment Areas Where Therapies’ Price Tags Can Run To Hundreds of Thousands of Dollars Annually.
▫️Neuromyelitis Optica (NMO) Is A Central Nervous System Disorder That Primarily Affects The Eye Nerves (Optic Neuritis) And The Spinal Cord (Myelitis). NMO Is Also Known As Neuromyelitis Optica Spectrum Disorder Or Devic's Disease.

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Oxford Covid-19 Vaccine Produces Strong Immune Response from Booster Shot - Study

▫️A Third Shot of The Oxford-AstraZeneca Covid-19 Vaccine Produces A Strong Immune Response, Researchers Said on Monday, Adding There Was Not Yet Evidence That Such Shots Were Needed, Especially Given Shortages In Some Countries.
▫️The Oxford University Study Found That A Third dose of The Vaccine Increases Antibody And T-Cell Immune Responses, While The Second dose Can Be Delayed Up To 45 Weeks And Also Lead To An Enhanced Immune Response.
▫️Studies Had Previously Shown That The Shot, Invented At Oxford University And Licensed To AstraZeneca Has Higher Efficacy When The Second dose Is Delayed To 12 Weeks Instead of Four Weeks.
▫️Monday’s Research Was Released In A Preprint, And Looked At 30 Participants Who Received A Late Second dose And 90 Who Received A Third dose, All of Whom Were Under 55.

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Study Suggests Vitamin B12 As A SARS-CoV-2 Antiviral

▫️Researchers In The UK And Spain Have Used A Novel Drug Screening Approach To Identify Compounds That Could Serve As Effective Antivirals Against SARS-CoV-2.
▫️In Vitro Analyses Revealed That Different Types of Vitamin B12 Were Effective At Inhibiting The Replication of SARS-CoV-2 Variants.
▫️A Pre-Print Version of The Research Paper Is Available on The bioRxiv Server While The Article Undergoes Peer Review.
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New Discovery Shows Human Cells Can Write RNA Sequences Into DNA

▫️Cells Contain Machinery That Duplicates DNA Into A New Set That Goes Into A Newly Formed Cell. That Same Class of Machines, Called Polymerases, Also Build RNA Messages, Which Are Like Notes Copied from The Central DNA Repository of Recipes, So They Can Be Read More Efficiently Into Proteins.
▫️Now, Thomas Jefferson University Researchers Provide The First Evidence That RNA segments Can Be Written Back Into DNA, Which Potentially Challenges The Central dogma In Biology And Could Have Wide Implications Affecting Many Fields of Biology.
▫️In A Series of Elegant Experiments, The Researchers Tested Polymerase Theta Against The Reverse Transcriptase from HIV, Which Is One of The Best Studied of Its Kind.
▫️They Showed That Polymerase Theta Was Capable of Converting RNA Messages Into DNA, Which It Did As Well As HIV Reverse Transcriptase, And That It Actually Did A Better Job Than When Duplicating DNA To DNA.
▫️The Work Was Published June 11th In The Journal Science Advances.
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Scientists Identify New Drugs That Could Be Repurposed Against Covid-19

▫️In A Study Published In Science Advances, A Team Led by Researchers At The University of Cambridge's Milner Therapeutics Institute Used A Combination of Computational Biology And Machine Learning To Create A Comprehensive Map of Proteins That Are Involved In SARS-CoV-2 Infection - from Proteins That Help The Virus Break Into The Host Cell To Those Generated As A Consequence of Infection.
▫️By Examining This Network Using Artificial Intelligence (AI) Approaches, They Were Able To Identify Key Proteins Involved In Infection As Well As Biological Pathways That Might Be Targeted by Drugs.
▫️The Team Used Computer Modeling To Carry Out A 'Virtual Screen' of Almost 2,000 Approved Drugs And Identified 200 Approved Drugs That Could be Effective Against Covid-19.
▫️When The Researchers Tested A Subset of Those Drugs Implicated In Viral Replication, They Found That Two In Particular, An Antimalarial Drug And A Type Of Medicine Used To Treat Rheumatoid Arthritis, Were Able To Inhibit The Virus, Providing Initial Validation of Their Data-Driven Approach.
▫️Sulfasalazine (used To Treat Conditions Such As Rheumatoid Arthritis And Crohn's disease) And Proguanil (And Antimalarial Drug), Which The Team Showed Reduced SARS-CoV-2 Viral Replication In Cells, Raising The Possibility of Their Potential Use To Prevent Infection Or To Treat Covid-19.
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VBI Vaccines’ Covid-19 Shot Induces Immune Responses In Phase I Trial

▫️VBI Vaccines Has Reported Preliminary Data from Phase I Part of Its Phase I/II Clinical Trial Where Its Covid-19 Vaccine Candidate, VBI-2902a, Induced Potent Immune Responses In Healthy Adult Subjects.
▫️A Monovalent And Enveloped Virus-Like Particle (eVLP) Covid-19-Specific Vaccine, VBI-2902 Expresses The SARS-CoV-2 Spike Protein. It Is Adjuvanted With Aluminium Phosphate To Form VBI-2902a.
▫️The Adaptive, Randomised, Observer-Blind, Placebo-Controlled Phase I/II Trial Is Currently Underway.
▫️The Phase I Part Analysed 5µg VBI-2902a In One-dose And Two-dose Vaccination Regimens, With The Second dose Being Administrated After 28 days.
▫️Phase I Enrolled 61 Healthy, Unvaccinated Adults Aged 18 to 54 Years.
▫️Data Showed That The 5µg dose Was Well-Tolerated And Induced Robust Immune Responses, Which Were Greater Than Those Observed In Human Convalescent Sera.

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CureVac Covid-19 Vaccine Records Only 48% Efficacy In Final Trial Readout

▫️CureVac Said Its Covid-19 Vaccine Was 48% Effective In The Final Analysis of Its Pivotal Mass Trial, Only Marginally Better Than The 47% Reported After An Initial Read-Out Two Weeks Ago.
▫️The German Biotech Firm Said That Efficacy, Measured by Preventing Symptomatic Disease, Was Slightly Better At 53% When Excluding Trial Participants Older Than 60 Years, An Age Group That Is By Far The Most Severely Affected.
▫️CureVac Said on June 16 Its Covid-19 Vaccine, Known As CVnCoV, Proved Only 47% Effective In An Initial Trial Read-Out And That New Variants Had Proved A Headwind, Denting Investor Confidence In Its Ability To Take On Rival Shots.
▫️The CureVac Study, Which Involved About 40,000 Adult Volunteers In Europe And Latin America, Showed That Efficacy Was 77% In The Age Group Below 60 Years of Age When Considering Only Moderate To Severe Symptoms And Excluding Mild Cases.

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AstraZeneca Begins Inoculation In Covid-19 Variant Vaccine Trial

▫️AstraZeneca Has Started The Inoculation of The First Subjects In A Phase II/III Clinical Trial of Its Covid-19 Variant Vaccine, AZD2816, To Prevent Infection from Variant SARS-CoV-2 Strains.
▫️AZD2816 Uses The Same Adenoviral Vector Platform As The Company’s Vaxzevria Covid-19 Vaccine, But With Slight Genetic Alterations To The Spike Protein Based on The Beta (B.1.351 Or South African) Variant.
▫️The New Variant Vaccine Has Ten Changes Across The Spike Protein, Including Those Found In Other "Variants of Concern".
▫️These Changes Decrease The Ability of Antibodies Stimulated Against The Original Virus To Inhibit Cell Entry, Increase Infectivity Than The Original Virus And Lower Neutralising Antibodies Sensitivity To The Original Virus, AstraZeneca Noted.
▫️The Partially Double-Blinded, Randomised, Multi-National, Active-Controlled Phase II/III Trial Will Assess The Safety And Immunogenicity of AZD2816 In Previously Vaccinated And Unvaccinated Adults Aged 18 Years And Above.
▫️It Will Enrol About 2,250 Subjects Across The UK, South Africa, Brazil And Poland. Subjects Will Be Given Intramuscular Vaxzevria Or AZD2816.

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Moderna's Covid-19 Vaccine Shows Promise Against Delta Variant in Lab Study

▫️Moderna Inc's Covid-19 Vaccine Showed Modest Reductions In Neutralizing Antibodies Against Emerging Variants, Including The Delta Variant First Identified In India, In A Lab Study, The Drugmaker Said on Tuesday.
▫️The Study Was Conducted on Blood Serum from Eight Participants Obtained One Week After They Received The Second dose of The Vaccine In An Early-Stage Trial, And Followed The Same Protocol As A Test Against Other Worrisome Variants That Was Published In The New England Journal of Medicine In April.
▫️In The New Test, Vaccination Produced Antibodies Capable of Neutralizing all Variants, Including Additional Versions of The Beta Variant First Identified In South Africa And Three Lineages of Variants First Identified In India, Including The Kappa (Also Known as B.1.617.1) And Delta (B.1.617.2) Variants.
▫️The Analysis Showed Some Reduction of Neutralization Against A Few of The Newer Variants, According To A Company Statement, Including Delta (2.1-fold), Kappa (3.3-3.4-fold), And Gamma - First Identified In Brazil - (3.2-fold).
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Covid-19 Vaccines Highly Effective Against Hospitalisation by Delta Variant

▫️New Data From Public Health England (PHE) Demonstrates That Pfizer-BioNTech’s And The Covid-19 Vaccine Oxford-AstraZeneca Are Both Effective At Preventing Hospitalisation From The Delta SARS-CoV-2 Variant.
▫️PHE Previously Established That The Delta Variant Is Up To 64 Percent More Transmissible Than The Alpha Variant (formerly The B.1.1.7- Variant), First Identified In The UK In September 2020.
▫️According To The New PHE Analysis, After Two doses:
- Pfizer/BioNTech’s Is 96 Percent Effective At Preventing Hospitalisation From The Delta SARS-CoV-2 Variant.
- And The Covid-19 Vaccine Oxford-AstraZeneca Is 92 Percent Effective Against Hospitalisation.
▫️Another Recently Published PHE Analysis Showed That One dose Is 17 Percent Less Effective At Preventing Symptomatic illness from The Delta Variant, Compared To Alpha, With Only A Small Difference After 2 doses.

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Adding Pembrolizumab to Chemo Provides Little or No Benefit In Urothelial Cancer

▫️In A Paper In The Lancet Oncology, Patients With Locally Advanced, Unresectable, Or Metastatic Urothelial Cancer May Not Derive Extra Benefit From The Addition of Pembrolizumab To Chemotherapy Or From Pembrolizumab Monotherapy, According To An Open-Label Phase-3 Trial.
▫️To Investigate, The Researchers Studied 1,010 Such Patients Who Were Randomized To Receive Pembrolizumab Plus Chemotherapy, Pembrolizumab Monotherapy, Or Chemotherapy Alone.

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Magnesium Strongly Tied to Lower Risk for Intracranial Aneurysm

▫️Higher Serum Magnesium Levels Appear To Reduce The Risk for Intracranial Aneurysm And Aneurysmal Subarachnoid Hemorrhage. The Effects May Be Partially Mediated by Magnesium's Influence on Systolic Blood Pressure, New Research Suggests.
▫️The Study Was Published Online June 22 In Neurology.
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Novavax’ Covid-19 Vaccine Almost 90 Percent Effective In Phase III Trials

▫️The Final Analysis of A Phase III Trial Published In The New England Journal of Medicine (NEJM) Shows That Novavax’ NVX-CoV2373 Covid-19 Vaccine Has An Overall Efficacy of 89.7 Percent With Over 60 Percent of The Cases Caused by The Alpha (B.1.1.7) Variant. Additionally, The Vaccine Was Found To Have A 96.4 Percent Efficacy Against Non-Alpha Variants, Which Represents Strains Most Similar To The Original Virus.
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