US FDA Approves Bristol Myers' Bowel Disease Treatment

▫️Bristol Myers Squibb Said on Thursday The U.S. Food And Drug Administration (FDA) Approved Its Oral Drug Zeposia® (Ozanimod) To Treat Adults With Ulcerative Colitis (UC), A Chronic Inflammatory Bowel Disease.
▫️Bristol Myers Gained The Drug, Approved Last Year for Treating Multiple Sclerosis Patients, In 2019 Through Its $74 Billion Buyout of Celgene.
▫️Zeposia, An Oral Medication Taken Once Daily, Is The First And Only Sphingosine 1-Phosphate (S1P) Receptor Modulator Approved for Patients With Moderately To Severely Active UC.
- It Will Compete With Takeda’s Entyvio (Vedolizumab), Which Was Approved for UC By The FDA In 2014.
▫️Zeposia Last Year June Met The Main Goals of A Late-Stage Study, Showing Patients Who Took It Achieved Clinical Remission of Ulcerative Colitis When Compared To Placebo.
▫️The European Medicines Agency Is Currently Reviewing The Marketing Application for Zeposia To Treat Ulcerative Colitis.

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FDA Approves Janssen’s Rybrevant For NSCLC Treatment

▫️The US Food And Drug Administration (FDA) Has Granted The Accelerated Approval To Janssen Pharmaceutical of Johnson And Johnson’s (J&J) Rybrevant (Amivantamab) To Treat Adults With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC).
▫️Rybrevant Is Indicated for NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Whose Disease Advanced On Or After Using Platinum-Containing Chemotherapy. The Drug Is The First Targeted Treatment To Receive FDA Approval In This Indication. A Fully Human, Bispecific Antibody, The Drug Is Designed To Target EGFR And MET Receptors. It Attaches Extracellularly And Hinders Tumour Growth, Causing The Death of Tumor Cells.
- In Addition, The FDA Has Also Approved Guardant Health’s Guardant360 CDx Liquid Biopsy Blood Test, Which Can Be Used As A Companion Diagnostic Along With Rybrevant.

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Pfizer-BioNTech Covid-19 Vaccine Recommended For Adolescents In Europe

▫️The Human Medicines Committee (CHMP) Of The European Medicines Agency (EMA) Has Recommended To Grant An Extension for The Covid-19 Vaccine Developed by Pfizer And BioNTech For Use In Those Aged 12 – 15 Years.
▫️The European Medicines Agency’s Endorsement Comes Weeks After It Began Evaluating Extending Use of The Vaccine.
▫️The EMA Said Two doses of The Vaccine, Branded As Comirnaty, Were Required in The 12-15 Age Group And Should Be Administered With An Interval of At Least Three Weeks, The Same As for Adults.
▫️This Month, The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) And Centers for Disease Control And Prevention (CDC) Have Both Started Investigating A Possible Link Between Pfizer Covid-19 Vaccine And Myocarditis.
▫️The American Heart Association (AHA) And American Stroke Association (ASA) Have Issued A Statement Saying That "The Benefits of The Vaccines Enormously Outweigh The Rare, Possible Risk of Heart-Related Complications, Including Inflammation of The Heart Muscle, Or Myocarditis.”

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AstraZeneca's Tagrisso Wins European Approval In Early Lung Cancer

▫️AstraZeneca’s Top-Selling Tagrisso (Osimertinib) Drug Has Been Approved For Use In The European Union To Treat Patients With Early-Stage EGFR Mutated Non-Small Cell Lung Cancer (NSCLC).
▫️The European Commission Has Approved The Lung Cancer Drug As An Add-on Treatment for Adults Diagnosed Early Enough For The Tumor To Be Surgically Removed, And Who Have A Mutation of The EGFR Gene, The British Drugmaker Said.
▫️The Approval Was Based on Positive Results From A Late-Stage Trial Called ADAURA, Which Showed Tagrisso Cut The Risk of The Tumor Growing Back In Patients Or Death by 80%.
▫️The Drug Is Now Approved To Treat Early-Stage Lung Cancer In More Than 50 Countries, Including, Most Recently, In The United States And China.
▫️The EGFR Mutation Is Found In About A Quarter of Global Lung Cancer Cases, And The Older Generation of EGFR Inhibitors Include Roche’s Tarceva And AstraZeneca’s Iressa.

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Platinum Chemotherapy Can Cause Leukemia In Children With Neuroblastoma, Shows Study

▫️Scientists from The Wellcome Sanger Institute And The University of Cambridge Found That In Children With Neuroblastoma, Treatment With Platinum Chemotherapy Caused Changes To The Genome That Could Then Cause Leukemia In Some Children Later on.
▫️The Findings, Published 27th May 2021 In Blood Could Lead To An Ability To Identify Which Children Are More Likely To Develop The Secondary Cancer.
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Distribution of Lithium In The Brain Plays Key Role In Depressive Disorders

▫️Lithium Is Familiar To Many of Us from Rechargeable Batteries. Most People Ingest Lithium on A Daily Basis in Drinking Water. International Studies Have Shown That A Higher Natural Lithium Content In Drinking Water Coincides With A Lower Suicide Rate Among The Population.
▫️Using Neutrons of The Research Neutron Source At The Technical University of Munich (TUM), A Research Team Has Now Proved That The Distribution of Lithium In The Brains of Depressive People Is Different from The Distribution Found In Healthy Humans.
▫️In Much Higher Concentrations Lithium Salts Have Been Used for Decades To Treat Mania And Depressive Disturbances. However, The Exact Role Lithium Plays In The Brain Is Still Unknown. See More
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Delaying Lung Cancer Surgery Associated With Higher Risk of Recurrence, Death

▫️For Patients With Early-Stage Non-Small Cell Lung Cancer, Surgical Removal of A Tumor-Infested Lung Or Of A Smaller Lung Section May Be The Only Treatment Needed. Worries About Contracting Covid-19 In A Clinical Setting Also Have Led To Delays.
▫️But A New Study by Researchers At Washington University School of Medicine in St. Louis found That Delaying Lung Cancer Surgery for More Than 12 Weeks from The Date of Diagnosis With A CT Scan Is Associated With A Higher Risk of Recurrence And Death.
▫️The Findings Are Published May 27 In JAMA Network Open.

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Covid-19: Pfizer-BioNTech Vaccine Is “Likely” Responsible For Deaths of Some Elderly Patients, Norwegian Review Finds

▫️The Pfizer-BioNTech Covid-19 Vaccine Is “Likely” To Have Been Responsible For At Least 10 Deaths of Frail Elderly People In Nursing Homes In Norway, An Expert Review Commissioned by The Norwegian Medicines Agency Has Concluded.
▫️The Expert Group Was Established At The End of February 2021 To Look Into The Cause of The First 100 Reported Deaths of Nursing Home Residents Who Had Received The Pfizer-BioNTech Vaccine.
https://doi.org/10.1136/bmj.n1372
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WHO Approves Sinovac Covid-19 Vaccine, The Second Chinese-Made Dose Listed

▫️The World Health Organization (WHO) Said on Tuesday It Has Approved A Covid-19 Vaccine Made by Drugmaker Sinovac Biotech for Emergency Use Listing, Paving The Way for A Second Chinese Shot To Be Used In Poor Countries.
▫️The Independent Panel of Experts Said In A Statement It Recommended Sinovac’s Vaccine for Adults Over 18, With A Second dose 2-4 Weeks Later.
▫️There Was No Upper Age Limit As Data Suggested It Is Likely To Have A Protective Effect In Older People.
▫️Branded CoronaVac In Some Regions, It Is The Second Chinese Developed Vaccine To Win Such WHO Listing To Combat Covid-19, After The May 7 Approval of A Shot Developed by State-Backed Sinopharm.
▫️A Third Chinese Vaccine, Produced by CanSino Biologics, Has Submitted Clinical Trial Data, But No WHO Review Has Been Scheduled.

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Pfizer Covid-19 Vaccine Linked To Myocarditis In Young Men, Says Israel's Health Ministry

▫️Israel Health Officials Have Found A Probable Link Between Pfizer And BioNTech Covid-19 Vaccine And dozens of Cases of Heart Inflammation In Young Men Following The Second dose of The Vaccine, The Health Ministry Said Late Tuesday.
▫️According To A Study by Health Officials, There Were 275 Cases of Myocarditis Identified Between December 2020, When The Vaccination Drive Began, And May 2021, Including 148 Cases Within A Month After Vaccination.
- Of These, 27 Cases Occurred After The First dose And 121 following The Second dose.
▫️The Study found “There Is A Probable Link Between Receiving The Second dose of Pfizer Covid-19 Vaccine And The Appearance of Myocarditis Among Men Aged 16 To 30,” It Said In A Statement. According To The Findings, Such A Link Was Observed More Among Men Aged 16 To 19 Than In Other Age Groups.

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Metal Ions Help Covid-19 Virus To Disguise Itself: Positively Charged Atoms Steady The Machinery That The Virus Uses To Trick The System

▫️Scientists from The University of Texas Health Science Center At San Antonio Have Discovered A Mechanism by Which SARS-CoV-2 Exploits Changes In Metal Ion Concentrations To Disguise Itself In The Body. Varying Concentrations of Metal Ions - Positively Charged Atoms Such As Magnesium, Manganese And Calcium - Are Observed In Hospitalized Covid-19 Patients. See More
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Study Confirms Poor Immunogenicity In Hemodialysis Patients Receiving Single dose Pfizer Covid-19 Vaccine

▫️Researchers From Ontario, Canada, Recently Conducted A Prospective Observational Study To Determine The SARS-CoV-2 Antibody Response In Chronic Hemodialysis Patients Following One vs. Two doses of The Pfizer Covid-19 Vaccine. The Results Were Compared To Health Care Worker Controls And Convalescent Serum.
▫️The Results Showed That 6% of Those Receiving One dose of The Vaccine Had An Anti-RBD Response Above The Median Level of Convalescent Serum vs. 41% of Those Who Received Two doses of The Vaccine.
▫️This Study Is Published on The PrePrint Server, MedRxiv.
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FDA Approves Amgen Drug For Lung Cancer With Specific Mutation

▫️The U.S. Food And Drug Administration (FDA) on Friday Approved An Amgen Inc Drug for Non-Small Cell Lung Cancer With A Specific Mutation In A Gene Known As KRAS In Patients Whose Disease Has Worsened After Treatment With Chemotherapy Or Other Medicines.
▫️The Drug, Sotorasib, Which Will Be Sold Under The Brand Name Lumakras, Shrank Tumors With The KRAS Mutation In Around 36% of Patients In Clinical Trials.
▫️The Medication Is Designed To Target A Gene Mutation Known As KRAS G12C That Occurs In About 13% of Non-Small Cell Lung Cancers (NSCLC), The Most Common Type of Lung Cancer.
▫️Amgen Said The Drug Will Have U.S. List Price of $17,900 Per Month.
▫️The Approval, Which Comes More Than Two Months Before The FDA’s Target Decision Date, Is For A Daily 960 Milligram Pill.

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Link Between Paracetamol Use During Pregnancy, Autism And ADHD Symptoms Supported by New Study

▫️In A Recently Published Epidemiological Study In The European Journal of Epidemiology, Researchers Confirmed That The Use of Paracetamol During Pregnancy Led To An Increased Risk of Children Displaying Symptoms of Attention-deficit Hyperactivity Disorder (ADHD) And Autism Spectrum Conditions (ASC).
▫️Researchers At The Barcelona Institute for Global Health, Have Carried Out An Epidemiological Study That They Claim Addresses Some Weaknesses of Previous, Similar Studies, And Supports A Proposed Link Between Maternal Use Of Paracetamol (Acetaminophen) During Pregnancy, And Symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) And Autism Spectrum Conditions (ASC) In Their Children.
▫️The Newly Reported Study, Which Included More Than 70,000 Children In Six European Cohorts, Found That Children Exposed To Paracetamol Before Birth Were 19% More Likely To Develop ASC Symptoms And 21% More Likely To Develop ADHD Symptoms Than Those Who Were Not Exposed.
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AstraZeneca's Lynparza Reduces Relapse, Death In Breast Cancer Patients

▫️AstraZeneca Drug Lynparza (Olaparib) Reduced The Risk of Relapse And Death In Breast Cancer Patients With Certain Mutations In A Late-Stage Trial, The British Drugmaker Said on Thursday.
▫️The Results, Published In The New England Journal of Medicine, Showed That The Drug Reduced The Combined Risk of Recurrence of Cancer Or Death from Any Cause by 42% Compared To A Placebo.
▫️Lynparza, Developed With Merck & Co Inc, Generated More Than $1 Billion In Sales Last Year For AstraZeneca And Has Become One of The Top Growth Drivers for The Drugmaker.
▫️The Treatment Belongs To A Class of Drugs Called PRAP Inhibitors That Stop Cancer Cells from Repairing Themselves After Damage from Chemotherapy.
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People Who Received Pfizer Covid-19 Vaccine Have Lower Antibody Levels Targeting The Delta Variant

▫️Levels of Antibodies In The Blood of Vaccinated People That Are Able To Recognize And Fight The New SARS-CoV-2 Delta Variant First Discovered In India (B.1.617.2) Are On Average Lower Than Those Against Previously Circulating Variants In The UK, According To New Laboratory Data from The Francis Crick Institute And The National Institute for Health Research (NIHR) UCLH Biomedical Research Centre, Published As A Research Letter In The Lancet.
▫️They Found That In People Who Had Been Fully Vaccinated With Two doses of The Pfizer-BioNTech Vaccine, Levels of Neutralizing Antibodies Were More Than Five Times Lower Against The B.1.617.2 Variant When Compared To The Original Strain, Upon Which Current Vaccines Are Based.
▫️After A Single dose of Pfizer-BioNTech, 79% of People Had A Quantifiable Neutralising Antibody Response Against The Original Strain, But This Fell To 50% For B.1.1.7, 32% For B.1.617.2 And 25% for B.1.351.
▫️The Results Also Show That Levels of These Antibodies Are Lower With Increasing Age And That Levels Decline Over Time, Providing Additional Evidence In Support of Plans To Deliver A Vaccination Boost To Vulnerable People In The Autumn.
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Prior Covid-19 Infection Reduces Infection Risk For Up To 10 Months

▫️The Risk of Being Infected With SARS-CoV-2, The Virus That Causes Covid-19, Is Substantially Reduced For Up To 10 Months Following A First Infection, According To New Findings Led by UCL Researchers.
▫️For The Study, Published In Lancet Healthy Longevity, Researchers Looked At Rates of Covid-19 Infections Between October And February Among More Than 2,000 Care Home Residents And Staff, Comparing Those Who Had Evidence of A Previous Infection Up To 10 Months Earlier, As Determined by Antibody Testing, With Those Who Had Not Been Previously Infected.

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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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