Novartis' Nuclear Therapy Helps Men With Prostate Cancer Live Longer: Data
▫️Men With A Deadly form of Advanced Prostate Cancer Who Failed Other Treatments Survived Four Months Longer After Getting An Experimental, Tumor-Targeting Radiation Therapy from Swiss Drugmaker Novartis, Data Released on Thursday Showed.
▫️The Company's Lu-PSMA-617 Therapy Boosted Median Overall Survival (OS) To 15.3 Months In Patients With Metastatic Castration-Resistant Prostate Cancer, According To Data Released At The 2021 American Society of Clinical Oncology Annual Meeting.
▫️That Compared With 11.3 Months for Men Who Got Standard Care.
▫️Men Who Got The Treatment Also Lived A Median 8.7 Months Without Their Cancer Progressing, More Than Double The 3.4-Month Progression Free Survival (PFS) of Those Who Did Not Get It, The Data Showed.
▫️The Therapy Attaches A Radioactive Isotope, Lutetium-177, With A Half-Life of Less Than Seven Days To A Small Molecule Drug, PSMA-617, That Binds To An Antigen Expressed In Large Amounts by Prostate Cancer Cells, With The Aim of Killing Them In A Targeted Way While Limiting Damage To Surrounding, Healthy Cells.
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▫️Men With A Deadly form of Advanced Prostate Cancer Who Failed Other Treatments Survived Four Months Longer After Getting An Experimental, Tumor-Targeting Radiation Therapy from Swiss Drugmaker Novartis, Data Released on Thursday Showed.
▫️The Company's Lu-PSMA-617 Therapy Boosted Median Overall Survival (OS) To 15.3 Months In Patients With Metastatic Castration-Resistant Prostate Cancer, According To Data Released At The 2021 American Society of Clinical Oncology Annual Meeting.
▫️That Compared With 11.3 Months for Men Who Got Standard Care.
▫️Men Who Got The Treatment Also Lived A Median 8.7 Months Without Their Cancer Progressing, More Than Double The 3.4-Month Progression Free Survival (PFS) of Those Who Did Not Get It, The Data Showed.
▫️The Therapy Attaches A Radioactive Isotope, Lutetium-177, With A Half-Life of Less Than Seven Days To A Small Molecule Drug, PSMA-617, That Binds To An Antigen Expressed In Large Amounts by Prostate Cancer Cells, With The Aim of Killing Them In A Targeted Way While Limiting Damage To Surrounding, Healthy Cells.
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FDA Extends Shelf Life of Johnson & Johnson Covid-19 Vaccine
▫️Johnson & Johnson (J&J) Said on Thursday The U.S. Food And Drug Administration (FDA) Has Extended The Shelf Life of Its Single-Shot Covid-19 Vaccine from Three Months To Four-And-A-Half Months, As Millions of Unused doses Nationwide Near Expiration.
▫️Safety Concerns About J&J’s Shot And Flagging Demand for Vaccinations Have Left Close To Half of The 21 Million doses The Company Has Produced for The United States Sitting Unused.
▫️The Health Regulator’s Decision Was Based on Data from Ongoing Studies, Which Demonstrated That The Vaccine Is Stable at 4.5 Months When Refrigerated At Temperatures of 36 To 46 Degrees Fahrenheit (2 To 8 Degrees Celsius), The Drugmaker Said.
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▫️Johnson & Johnson (J&J) Said on Thursday The U.S. Food And Drug Administration (FDA) Has Extended The Shelf Life of Its Single-Shot Covid-19 Vaccine from Three Months To Four-And-A-Half Months, As Millions of Unused doses Nationwide Near Expiration.
▫️Safety Concerns About J&J’s Shot And Flagging Demand for Vaccinations Have Left Close To Half of The 21 Million doses The Company Has Produced for The United States Sitting Unused.
▫️The Health Regulator’s Decision Was Based on Data from Ongoing Studies, Which Demonstrated That The Vaccine Is Stable at 4.5 Months When Refrigerated At Temperatures of 36 To 46 Degrees Fahrenheit (2 To 8 Degrees Celsius), The Drugmaker Said.
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Aspirin Does Not Improve Survival In Covid-19 Patients: UK Study
▫️Aspirin Does Not Improve The Chances of Survival In Severely ill Covid-19 Patients, Early Results from One of Britain's Biggest Trials Studying The Commonly Used Painkiller And Blood Thinner Showed on Tuesday.
▫️The Scientists Behind The Trial, Which Is Looking Into A Range of Potential Treatments For Covid-19, Evaluated Aspirin's Effects on Nearly 15,000 Hospitalized Patients Infected With The Novel Coronavirus.
- Since The Drug Helps Reduce Blood Clots In Other Diseases, It Was Tested In Covid-19 Patients Who Are At A Higher Risk of Clotting Issues.
▫️The Trial, Run by The University of Oxford, Is Also Looking At The Effectiveness of Several Other Treatments, And Was The First To Show That The Widely Available Steroid Dexamethasone, Could Save Lives of People Severely ill With Covid-19.
▫️The Aspirin Study Did Not Show Any Significant Change To The Risk of Patients Progressing To Invasive Mechanical Ventilation. For Every 1,000 Patients Treated With The Medicine, About Six More Patients Experienced A Major Bleeding Event And About Six Fewer Experienced A Clotting Event, Oxford Said.
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▫️Aspirin Does Not Improve The Chances of Survival In Severely ill Covid-19 Patients, Early Results from One of Britain's Biggest Trials Studying The Commonly Used Painkiller And Blood Thinner Showed on Tuesday.
▫️The Scientists Behind The Trial, Which Is Looking Into A Range of Potential Treatments For Covid-19, Evaluated Aspirin's Effects on Nearly 15,000 Hospitalized Patients Infected With The Novel Coronavirus.
- Since The Drug Helps Reduce Blood Clots In Other Diseases, It Was Tested In Covid-19 Patients Who Are At A Higher Risk of Clotting Issues.
▫️The Trial, Run by The University of Oxford, Is Also Looking At The Effectiveness of Several Other Treatments, And Was The First To Show That The Widely Available Steroid Dexamethasone, Could Save Lives of People Severely ill With Covid-19.
▫️The Aspirin Study Did Not Show Any Significant Change To The Risk of Patients Progressing To Invasive Mechanical Ventilation. For Every 1,000 Patients Treated With The Medicine, About Six More Patients Experienced A Major Bleeding Event And About Six Fewer Experienced A Clotting Event, Oxford Said.
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Unusual Copper And Iron Found Forming In Brains of Alzheimer's Patients
▫️A Team of Researchers Associated With Several Institutions In The U.K., Germany And The U.S. Has Found Evidence of An Unusual Kind of Copper And Iron in The Brains of Alzheimer's Patients.
▫️In Their Paper Published In The Journal Science Advances, The Group Describes Their Discovery of The Metals In Two Alzheimer's Patients And What It Could Mean for The Study And Treatment of The Disease.
▫️The Researchers Suggest The Metals They found Could Explain How Alzheimer's Harms Cells - Their Surfaces Would Be Highly Reactive, Which Could Lead To Damage When Exposed To Brain Cells.
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▫️A Team of Researchers Associated With Several Institutions In The U.K., Germany And The U.S. Has Found Evidence of An Unusual Kind of Copper And Iron in The Brains of Alzheimer's Patients.
▫️In Their Paper Published In The Journal Science Advances, The Group Describes Their Discovery of The Metals In Two Alzheimer's Patients And What It Could Mean for The Study And Treatment of The Disease.
▫️The Researchers Suggest The Metals They found Could Explain How Alzheimer's Harms Cells - Their Surfaces Would Be Highly Reactive, Which Could Lead To Damage When Exposed To Brain Cells.
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Science
Biogenic metallic elements in the human brain?
The chemistry of copper and iron plays a critical role in normal brain function. A variety of enzymes and proteins containing positively charged Cu+, Cu2+, Fe2+, and Fe3+ control key processes, catalyzing oxidative metabolism and neurotransmitter and neuropeptide…
Oxford Covid-19 Vaccine Inventors Recognised In Queen’s Birthday Honours
▫️The Oxford University Scientists Who Invented The Oxford-AstraZeneca Covid-19 Vaccine Are Among Those To Be Honoured by Queen Elizabeth, Among A Number of Recipients Who Played Key Roles In Britain’s Coronavirus Response, The Government Said on Friday.
▫️Sarah Gilbert, The Oxford Jenner Institute Scientist Who Co-developed The Vaccine, Will be Made A Dame, While Her Colleague, The Institute's Director, Adrian Hill, Is To Receive An Honorary Knighthood.
▫️Andrew Pollard, The Head of The Oxford Vaccine Group Who Ran Trials of The Vaccine, Is To Be Made A Knight Bachelor, An Honor Also Bestowed on Peter Horby And Martin Landray, The Oxford Scientists Behind The Trial Which Showed Dexamethasone Could Be Used To Treat Severely ill Covid-19 Patients.
▫️Kate Bingham, Who Was Praised for Her Work As Head of The Government's Vaccines Taskforce, Which Procured Hundreds of Millions of Covid-19 Vaccines for The British Government, Is Also To Become A Dame.
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▫️The Oxford University Scientists Who Invented The Oxford-AstraZeneca Covid-19 Vaccine Are Among Those To Be Honoured by Queen Elizabeth, Among A Number of Recipients Who Played Key Roles In Britain’s Coronavirus Response, The Government Said on Friday.
▫️Sarah Gilbert, The Oxford Jenner Institute Scientist Who Co-developed The Vaccine, Will be Made A Dame, While Her Colleague, The Institute's Director, Adrian Hill, Is To Receive An Honorary Knighthood.
▫️Andrew Pollard, The Head of The Oxford Vaccine Group Who Ran Trials of The Vaccine, Is To Be Made A Knight Bachelor, An Honor Also Bestowed on Peter Horby And Martin Landray, The Oxford Scientists Behind The Trial Which Showed Dexamethasone Could Be Used To Treat Severely ill Covid-19 Patients.
▫️Kate Bingham, Who Was Praised for Her Work As Head of The Government's Vaccines Taskforce, Which Procured Hundreds of Millions of Covid-19 Vaccines for The British Government, Is Also To Become A Dame.
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Clinical Trial Launched Following Discovery That Psychiatric Drug May Prevent Bowel Cancer
▫️The Study, Published In The Journal Nature, Shows How A Drug Available on The NHS Can Boost Fitness of Healthy Stem Cells In The Gut, Making Them More Resistant To Sabotage from Mutant Stem Cells That Cause Cancer.
▫️Researchers In The Netherlands, Funded by The UK Charity Worldwide Cancer Research, Have Discovered A Way To Boost The fitness of Healthy Cells In The Gut To Prevent The Development of Bowel Cancer.
▫️Lithium, A Commonly Used Drug for The Treatment of Several Psychiatric Disorders, Prevented The Mutant Stem Cells from Taking Over And Forming Tumors In Mice by Rendering The Healthy Stem Cells Insensitive To The Damaging Signals.
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▫️The Study, Published In The Journal Nature, Shows How A Drug Available on The NHS Can Boost Fitness of Healthy Stem Cells In The Gut, Making Them More Resistant To Sabotage from Mutant Stem Cells That Cause Cancer.
▫️Researchers In The Netherlands, Funded by The UK Charity Worldwide Cancer Research, Have Discovered A Way To Boost The fitness of Healthy Cells In The Gut To Prevent The Development of Bowel Cancer.
▫️Lithium, A Commonly Used Drug for The Treatment of Several Psychiatric Disorders, Prevented The Mutant Stem Cells from Taking Over And Forming Tumors In Mice by Rendering The Healthy Stem Cells Insensitive To The Damaging Signals.
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Nature
Apc-mutant cells act as supercompetitors in intestinal tumour initiation
Nature - Using experiments in organoids and in vivo in mice, the authors show that Apc-mutant cells act as supercompetitors to initiate the formation of adenomas.
German Panel Gives Limited Approval For Covid-19 Shot For Adolescents
▫️Germany's Vaccine Advisory Committee, Known As STIKO, Recommended on Thursday That Only Children And Adolescents With Pre-Existing Conditions Should Be Given The Covid-19 Vaccine Produced by Pfizer And BioNTech.
▫️STIKO Said In A Statement That It Recommends A Vaccination Only for Those Youngsters With An illness That Raises Their Risk of A Serious Case of Coronavirus.
▫️It Said It Was Not Currently Recommending The Use of The Vaccine for Those Aged 12-17 Without Pre-Existing Conditions, Although Noted Doctors Were Allowed To Give The Shot If The Individual Accepts The Risk.
▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
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▫️Germany's Vaccine Advisory Committee, Known As STIKO, Recommended on Thursday That Only Children And Adolescents With Pre-Existing Conditions Should Be Given The Covid-19 Vaccine Produced by Pfizer And BioNTech.
▫️STIKO Said In A Statement That It Recommends A Vaccination Only for Those Youngsters With An illness That Raises Their Risk of A Serious Case of Coronavirus.
▫️It Said It Was Not Currently Recommending The Use of The Vaccine for Those Aged 12-17 Without Pre-Existing Conditions, Although Noted Doctors Were Allowed To Give The Shot If The Individual Accepts The Risk.
▫️The CDC And Other Health Regulators Have Been Investigating Heart Inflammation Cases Had Found A Likely Link To The Condition In Young Men Who Received Pfizer’s Covid-19 Vaccine.
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UK Study Finds Vaccines Offer High Protection Against Hospitalisation from Delta Variant
▫️Covid-19 Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalisation from The Delta Coronavirus Variant, A New Analysis by Public Health England (PHE) Showed on Monday.
▫️PHE Said That The Pfizer-BionTech Covid-19 Vaccine Was 96% Effective Against Hospitalisation from The Delta Variant After Two doses, While AstraZeneca's Offered 92% Protection Against Hospitalisation by Delta.
▫️PHE Said That Those Levels Of Protection Were Comparable To That Against The Alpha Variant, First Identified In Kent, Southeast England.
▫️The Analysis Adds To Evidence That, Although The Delta Variant Reduces The Effectiveness of Vaccines Against Symptomatic Infection, Two doses of Covid-19 Vaccine Still Protect Against Severe Disease.
▫️The PHE Findings Follow A Scottish Study Which Showed That Two doses of A Covid-19 Vaccine Among People Who Tested Positive Cut Their Risk of Hospitalisation by 70%, Although There Were Not Enough Hospital Admissions Reported To Compare The Vaccines.
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▫️Covid-19 Vaccines Made by Pfizer And AstraZeneca Offer High Protection of More Than 90% Against Hospitalisation from The Delta Coronavirus Variant, A New Analysis by Public Health England (PHE) Showed on Monday.
▫️PHE Said That The Pfizer-BionTech Covid-19 Vaccine Was 96% Effective Against Hospitalisation from The Delta Variant After Two doses, While AstraZeneca's Offered 92% Protection Against Hospitalisation by Delta.
▫️PHE Said That Those Levels Of Protection Were Comparable To That Against The Alpha Variant, First Identified In Kent, Southeast England.
▫️The Analysis Adds To Evidence That, Although The Delta Variant Reduces The Effectiveness of Vaccines Against Symptomatic Infection, Two doses of Covid-19 Vaccine Still Protect Against Severe Disease.
▫️The PHE Findings Follow A Scottish Study Which Showed That Two doses of A Covid-19 Vaccine Among People Who Tested Positive Cut Their Risk of Hospitalisation by 70%, Although There Were Not Enough Hospital Admissions Reported To Compare The Vaccines.
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Oxford Covid-19 Shots Have Good Risk-Benefit Profile for Over 60s: EMA Official Says
▫️Oxford-AstraZeneca Shots Have Good Risk-Benefit Profile For Over 60s, Says EMA Official.
▫️The Head of The EU Drug Regulator’s Covid-19 Task Force Said on Sunday That AstraZeneca’s Covid-19 Vaccine Had A Favourable Risk-Benefit Profile For All Age Groups And Particularly For Those Aged Over 60.
▫️Italian Newspaper La Stampa Earlier Quoted European Medicines Agency (EMA) Task Force Chief Marco Cavaleri As Saying Countries Should Avoid Giving The Vaccine To People Aged Over 60 In Addition To Younger Age Groups, Amid Fears Over Very Rare Blood Clotting And As Alternative Vaccines Become Available.
- The AstraZeneca Shot “Maintains A Favourable Benefit Risk Profile In All Ages But Particularly In The Elderly Above 60,” He Said.
▫️The EMA’s Position Is That The AstraZeneca Shot Is Safe And Can Be Used For All Age Groups Over 18.
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▫️Oxford-AstraZeneca Shots Have Good Risk-Benefit Profile For Over 60s, Says EMA Official.
▫️The Head of The EU Drug Regulator’s Covid-19 Task Force Said on Sunday That AstraZeneca’s Covid-19 Vaccine Had A Favourable Risk-Benefit Profile For All Age Groups And Particularly For Those Aged Over 60.
▫️Italian Newspaper La Stampa Earlier Quoted European Medicines Agency (EMA) Task Force Chief Marco Cavaleri As Saying Countries Should Avoid Giving The Vaccine To People Aged Over 60 In Addition To Younger Age Groups, Amid Fears Over Very Rare Blood Clotting And As Alternative Vaccines Become Available.
- The AstraZeneca Shot “Maintains A Favourable Benefit Risk Profile In All Ages But Particularly In The Elderly Above 60,” He Said.
▫️The EMA’s Position Is That The AstraZeneca Shot Is Safe And Can Be Used For All Age Groups Over 18.
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Novavax Covid-19 Vaccine More Than 90% Effective In U.S. Trial
▫️Novavax Inc on Monday Said Its Covid-19 Vaccine Was More Than 90% Effective, Including Against A Variety of Concerning Variants of The Coronavirus In A Large, Late-Stage US-Based Clinical Trial.
▫️The Study of Nearly 30,000 Volunteers In The United States And Mexico Puts Novavax on Track To File For Emergency Authorization In The United States And Elsewhere In The Third Quarter of 2021, The Company Said.
▫️The Protein-Based Vaccine Was More Than 93% Effective Against The More Easily Transmissible Predominant Coronavirus Variants That Have Caused Concern Among Scientists And Public Health Officials, Novavax Said.
▫️Protein-Based Vaccines Are A Conventional Approach That Use Purified Pieces of The Virus To Spur An Immune Response, Such As Those Used Against Whooping Cough And Shingles.
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▫️Novavax Inc on Monday Said Its Covid-19 Vaccine Was More Than 90% Effective, Including Against A Variety of Concerning Variants of The Coronavirus In A Large, Late-Stage US-Based Clinical Trial.
▫️The Study of Nearly 30,000 Volunteers In The United States And Mexico Puts Novavax on Track To File For Emergency Authorization In The United States And Elsewhere In The Third Quarter of 2021, The Company Said.
▫️The Protein-Based Vaccine Was More Than 93% Effective Against The More Easily Transmissible Predominant Coronavirus Variants That Have Caused Concern Among Scientists And Public Health Officials, Novavax Said.
▫️Protein-Based Vaccines Are A Conventional Approach That Use Purified Pieces of The Virus To Spur An Immune Response, Such As Those Used Against Whooping Cough And Shingles.
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Delta Variant Doubles Risk of Covid-19 Hospitalization
▫️The Delta Variant of The Coronavirus First Identified In India May Double The Risk of Hospitalization Among Covid-19 Patients, Compared With The Alpha Variant First Discovered In The UK, A Study from Scotland Suggests.
▫️Researchers Looked At 19,543 Covid-19 Cases And 377 Hospitalizations Among 5.4 Million People, Including 7,723 Cases And 134 Hospitalizations In Patients With The Delta Variant, Who Tended To Be Younger And More Affluent.
▫️The Risk of Covid-19 Hospital Admission Was About Double With The delta Variant Compared To The Alpha Variant, With The Risk Particularly Increased In Those With Five Or More Medical Conditions Known To Contribute To More Severe Disease, The Researchers Reported on Monday In The Lancet.
▫️They Found That Two doses of The Vaccines from Pfizer-BioNTech And from Oxford-AstraZeneca Still Provide Strong Protection, Although Not As Strong As The Protection Provided Against The Alpha Variant (B.1.1.7).
▫️Two Weeks After The Second dose, The Pfizer-BioNTech Vaccine Was found To Provide 79% Protection Against Infection from The Delta Variant, Compared To 92% Against The Alpha Variant.
▫️With Oxford-AstraZeneca's Vaccine, There Was 60% Protection Against Delta Variant Compared With 73% for Alpha. Because This Was An Observational Study, More Research Is Needed To Confirm The Findings, The Research Team Said.
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▫️The Delta Variant of The Coronavirus First Identified In India May Double The Risk of Hospitalization Among Covid-19 Patients, Compared With The Alpha Variant First Discovered In The UK, A Study from Scotland Suggests.
▫️Researchers Looked At 19,543 Covid-19 Cases And 377 Hospitalizations Among 5.4 Million People, Including 7,723 Cases And 134 Hospitalizations In Patients With The Delta Variant, Who Tended To Be Younger And More Affluent.
▫️The Risk of Covid-19 Hospital Admission Was About Double With The delta Variant Compared To The Alpha Variant, With The Risk Particularly Increased In Those With Five Or More Medical Conditions Known To Contribute To More Severe Disease, The Researchers Reported on Monday In The Lancet.
▫️They Found That Two doses of The Vaccines from Pfizer-BioNTech And from Oxford-AstraZeneca Still Provide Strong Protection, Although Not As Strong As The Protection Provided Against The Alpha Variant (B.1.1.7).
▫️Two Weeks After The Second dose, The Pfizer-BioNTech Vaccine Was found To Provide 79% Protection Against Infection from The Delta Variant, Compared To 92% Against The Alpha Variant.
▫️With Oxford-AstraZeneca's Vaccine, There Was 60% Protection Against Delta Variant Compared With 73% for Alpha. Because This Was An Observational Study, More Research Is Needed To Confirm The Findings, The Research Team Said.
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Novavax Covid-19 Vaccine Co-Administered With Flu Vaccine Appears Safe And Effective
▫️Novavax Inc Said on Monday Vaccine Efficacy Appeared To Be Preserved In Those Receiving An Approved Influenza Vaccine Along With Its Covid-19 Vaccine Candidate Compared To Those Receiving Its Covid-19 Vaccine Alone.
▫️The Company Released The Results from A Sub-Study It Conducted As Part of Its Late-Stage Clinical Trial of NVX-CoV2373, Its Protein-Based Covid-19 Vaccine Candidate, In The United Kingdom.
▫️The 431 Participants Enrolled In The Sub-Study Received An Approved Seasonal Influenza Vaccine With About Half The Participants Administered NVX-CoV2373, While The Rest Received Placebo.
▫️The Company Said Vaccine Efficacy Was 87.5% Compared To 89.8% In The Main Study.
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▫️Novavax Inc Said on Monday Vaccine Efficacy Appeared To Be Preserved In Those Receiving An Approved Influenza Vaccine Along With Its Covid-19 Vaccine Candidate Compared To Those Receiving Its Covid-19 Vaccine Alone.
▫️The Company Released The Results from A Sub-Study It Conducted As Part of Its Late-Stage Clinical Trial of NVX-CoV2373, Its Protein-Based Covid-19 Vaccine Candidate, In The United Kingdom.
▫️The 431 Participants Enrolled In The Sub-Study Received An Approved Seasonal Influenza Vaccine With About Half The Participants Administered NVX-CoV2373, While The Rest Received Placebo.
▫️The Company Said Vaccine Efficacy Was 87.5% Compared To 89.8% In The Main Study.
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medRxiv
Safety, Immunogenicity, and Efficacy of a COVID-19 Vaccine (NVX-CoV2373) Co-administered With Seasonal Influenza Vaccines
Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines has not yet been reported.
Methods A sub-study on influenza vaccine co-administration was conducted as part of the phase…
Methods A sub-study on influenza vaccine co-administration was conducted as part of the phase…
Prior Vaccination Against Diphtheria And Tetanus Associated With Less Severe Covid-19
▫️Older Individuals Who Have Gotten A Diphtheria Or Tetanus Vaccine Booster Shot In The Last 10 Years May Be At Lower Risk For Severe Covid-19, A New Study Suggests.
▫️Using A Large UK Registry, Researchers Looked Back At 10 Years of Immunization Records from 103,409 Participants With An Average Age of 71.
▫️They Saw A Trend Toward A Lower Risk of A Positive Covid-19 Test In People Who Had Gotten A Tetanus Or Diphtheria Booster Shot During The Study Period, Although The Difference Was Small And Might Have Been Due To Chance.
▫️There Was, However, A Statistically Significant Association Between The Booster Shots And The Odds of Severe Covid-19, According To A Report Posted on medRxiv on Saturday Ahead of Peer Review.
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▫️Older Individuals Who Have Gotten A Diphtheria Or Tetanus Vaccine Booster Shot In The Last 10 Years May Be At Lower Risk For Severe Covid-19, A New Study Suggests.
▫️Using A Large UK Registry, Researchers Looked Back At 10 Years of Immunization Records from 103,409 Participants With An Average Age of 71.
▫️They Saw A Trend Toward A Lower Risk of A Positive Covid-19 Test In People Who Had Gotten A Tetanus Or Diphtheria Booster Shot During The Study Period, Although The Difference Was Small And Might Have Been Due To Chance.
▫️There Was, However, A Statistically Significant Association Between The Booster Shots And The Odds of Severe Covid-19, According To A Report Posted on medRxiv on Saturday Ahead of Peer Review.
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medRxiv
Vaccination history for diphtheria and tetanus is associated with less severe COVID-19
Background COVID-19 is characterized by strikingly large, mostly unexplained, interindividual variation in symptom severity. While some individuals remain nearly asymptomatic, others suffer from severe respiratory failure. It has been hypothesized that previous…
Humanigen Starts Rolling Submission For Covid-19 Drug In The UK
▫️Humanigen Has Commenced A Rolling Review Submission To The UK Medicines And Healthcare Products Regulatory Agency (MHRA), Seeking Marketing Approval For Its Drug Candidate, Lenzilumab.
▫️A Monoclonal Antibody, Lenzilumab Is Designed To Neutralize Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).
▫️This Development Comes After The Company Applied for Emergency Use Authorization (EUA) of The Drug by The US Food And Drug Administration (FDA).
▫️The Latest Application To The MHRA Is Based on Favourable Results from The Phase III LIVE-AIR Clinical Study.
▫️Data from This Trial Showed That Lenzilumab Met The Primary Goal With A 54% Relative Improvement In The Chances of Survival Without Ventilation (SWOV) Versus Placebo.
▫️In Participants Receiving Both Corticosteroids And Remdesivir, Lenzilumab Provided A 92% Improvement In Relative Chances of SWOV. This Improvement Was Found To Be Three-fold In Participants With A CRP<150mg/L And Aged Below 85 Years.
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▫️Humanigen Has Commenced A Rolling Review Submission To The UK Medicines And Healthcare Products Regulatory Agency (MHRA), Seeking Marketing Approval For Its Drug Candidate, Lenzilumab.
▫️A Monoclonal Antibody, Lenzilumab Is Designed To Neutralize Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).
▫️This Development Comes After The Company Applied for Emergency Use Authorization (EUA) of The Drug by The US Food And Drug Administration (FDA).
▫️The Latest Application To The MHRA Is Based on Favourable Results from The Phase III LIVE-AIR Clinical Study.
▫️Data from This Trial Showed That Lenzilumab Met The Primary Goal With A 54% Relative Improvement In The Chances of Survival Without Ventilation (SWOV) Versus Placebo.
▫️In Participants Receiving Both Corticosteroids And Remdesivir, Lenzilumab Provided A 92% Improvement In Relative Chances of SWOV. This Improvement Was Found To Be Three-fold In Participants With A CRP<150mg/L And Aged Below 85 Years.
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FDA Declines To Approve Avenue’s Intravenous Use of Tramadol
▫️The US Food And Drug Administration (FDA) Has Declined To Approve Avenue Therapeutics’ New Drug Application (NDA) For Intravenous (IV) Use of Analgesic Tramadol for A Second Time.
▫️In Its Second Complete Response Letter (CRL) To The Company, The FDA Said That The Delayed And Unpredictable Onset of Analgesia With IV Tramadol Did Not Support Its Use As A Monotherapy For Treating Patients In Acute Pain.
▫️The FDA Also Noted The Inadequate Data Supporting The Usage of IV Tramadol With Other Analgesics As A Safe And Effective Option To Treat The Intended Patient Population.
- The Agency Did Not Notify Any Chemistry, Manufacturing And Controls (CMC) Issues In The Latest CRL.
▫️Avenue Does Not Agree With The FDA’s Interpretation of The Data Provided In The NDA And Plans To Seek Regulatory Approval For IV Tramadol.
▫️A Speciality Pharmaceutical Company, Avenue Focuses on Developing IV Tramadol As A Probable Substitute To Lower The Use of Standard Opioids for Treating People With Acute Pain In The US.
▫️According To The FDA, If A Patient With Acute Pain Needs An Analgesic Between The First IV Tramadol dose And The Onset of Analgesia, A Rescue Analgesic Would Be Required.
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▫️The US Food And Drug Administration (FDA) Has Declined To Approve Avenue Therapeutics’ New Drug Application (NDA) For Intravenous (IV) Use of Analgesic Tramadol for A Second Time.
▫️In Its Second Complete Response Letter (CRL) To The Company, The FDA Said That The Delayed And Unpredictable Onset of Analgesia With IV Tramadol Did Not Support Its Use As A Monotherapy For Treating Patients In Acute Pain.
▫️The FDA Also Noted The Inadequate Data Supporting The Usage of IV Tramadol With Other Analgesics As A Safe And Effective Option To Treat The Intended Patient Population.
- The Agency Did Not Notify Any Chemistry, Manufacturing And Controls (CMC) Issues In The Latest CRL.
▫️Avenue Does Not Agree With The FDA’s Interpretation of The Data Provided In The NDA And Plans To Seek Regulatory Approval For IV Tramadol.
▫️A Speciality Pharmaceutical Company, Avenue Focuses on Developing IV Tramadol As A Probable Substitute To Lower The Use of Standard Opioids for Treating People With Acute Pain In The US.
▫️According To The FDA, If A Patient With Acute Pain Needs An Analgesic Between The First IV Tramadol dose And The Onset of Analgesia, A Rescue Analgesic Would Be Required.
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Researchers Identify Why Covid-19 Patients Develop Life-Threatening Clots
▫️Previous Research Has Established That Blood Clotting Is A Significant Cause Of Death In Patients With Covid-19. To Understand Why That Clotting Happens, The Researchers Analyzed Blood Samples That Were Taken from Patients With Covid-19 In The Beaumont Hospital Intensive Care Unit In Dublin.
▫️They Found That The Balance Between A Molecule That Causes Clotting, Called Von Willebrand Factor (VWF), And Its Regulator, Called ADAMTS13, Is Severely Disrupted In Patients With Severe Covid-19.
▫️When Compared To Control Groups, The Blood of Covid-19 Patients Had Higher Levels of The Pro-Clotting VWF Molecules And Lower Levels of The Anti-Clotting ADAMTS13.
▫️The Work, Led by Researchers from RCSI University of Medicine And Health Sciences, Is Published In The Journal of Thrombosis And Haemostasis.
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▫️Previous Research Has Established That Blood Clotting Is A Significant Cause Of Death In Patients With Covid-19. To Understand Why That Clotting Happens, The Researchers Analyzed Blood Samples That Were Taken from Patients With Covid-19 In The Beaumont Hospital Intensive Care Unit In Dublin.
▫️They Found That The Balance Between A Molecule That Causes Clotting, Called Von Willebrand Factor (VWF), And Its Regulator, Called ADAMTS13, Is Severely Disrupted In Patients With Severe Covid-19.
▫️When Compared To Control Groups, The Blood of Covid-19 Patients Had Higher Levels of The Pro-Clotting VWF Molecules And Lower Levels of The Anti-Clotting ADAMTS13.
▫️The Work, Led by Researchers from RCSI University of Medicine And Health Sciences, Is Published In The Journal of Thrombosis And Haemostasis.
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Wiley Online Library
ADAMTS13 regulation of VWF multimer distribution in severe COVID‐19
Background
Consistent with fulminant endothelial cell activation, elevated plasma von Willebrand factor (VWF) antigen levels have been reported in patients with COVID-19. The multimeric size and fun...
Consistent with fulminant endothelial cell activation, elevated plasma von Willebrand factor (VWF) antigen levels have been reported in patients with COVID-19. The multimeric size and fun...
Cholesterol-Lowering Drugs Appear To Boost Cancer Immunotherapies
▫️Based on The Findings, Human Studies Are Already Being Proposed To Determine Whether Cholesterol Drugs Such As Evolocumab (Sold As Repatha) Or Alirocumab (Praluent) Might Bolster The Effect of Immune Checkpoint Inhibitors. These Cancer Immunotherapies Have Held Great Promise, But Still Only Result In Long-Term Survival Benefits For A Third of Cancer Patients, At Most.
▫️The Study Appears Online Nov. 11 In The Journal Nature.
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▫️Based on The Findings, Human Studies Are Already Being Proposed To Determine Whether Cholesterol Drugs Such As Evolocumab (Sold As Repatha) Or Alirocumab (Praluent) Might Bolster The Effect of Immune Checkpoint Inhibitors. These Cancer Immunotherapies Have Held Great Promise, But Still Only Result In Long-Term Survival Benefits For A Third of Cancer Patients, At Most.
▫️The Study Appears Online Nov. 11 In The Journal Nature.
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Nature
Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer
Inhibiting the PCSK9 protein, a regulator of cholesterol metabolism, enhances immune checkpoint therapy in mouse models of cancer, in a manner that depends on the regulation of antigen-presenting MHC I molecules.
CureVac Preliminary Data Shows Covid-19 Vaccine Is Only 47% Effective
▫️German Biotech CureVac Said on Wednesday Its Covid-19 Vaccine Was Only 47% Effective In A Late-Stage Trial, Missing The Study’s Main Goal And Throwing In Doubt The Potential Delivery of Hundreds of Millions of doses To The European Union.
▫️In Its Study of 40,000 People, CureVac Said 13 Variants Were Found In Volunteers, With More Than Half of The Coronavirus Cases Caused by Variants of Concern.
▫️The Disappointing Efficacy of The Shot Known As CVnCoV Emerged from An Interim Analysis Based on 134 Covid-19 Cases In The Study With About 40,000 Volunteers In Europe And Latin America.
▫️Out of The Reported Covid-19 Cases In The Trial, 124 Were Sequenced To Identify The Variant Causing The Infection, It Said. One Case Was Attributable To The Original Version of The SARS-CoV-2 Coronavirus That Emerged In Chinese City of Wuhan In Late 2019, While 57% of The Cases Were Caused by More Highly Transmissible So-Called "Variants of Concern".
▫️CureVac's U.S. Traded Shares Fell 50.6% To $46.81 In After-Hours Trading Following Publication of The Data.
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▫️German Biotech CureVac Said on Wednesday Its Covid-19 Vaccine Was Only 47% Effective In A Late-Stage Trial, Missing The Study’s Main Goal And Throwing In Doubt The Potential Delivery of Hundreds of Millions of doses To The European Union.
▫️In Its Study of 40,000 People, CureVac Said 13 Variants Were Found In Volunteers, With More Than Half of The Coronavirus Cases Caused by Variants of Concern.
▫️The Disappointing Efficacy of The Shot Known As CVnCoV Emerged from An Interim Analysis Based on 134 Covid-19 Cases In The Study With About 40,000 Volunteers In Europe And Latin America.
▫️Out of The Reported Covid-19 Cases In The Trial, 124 Were Sequenced To Identify The Variant Causing The Infection, It Said. One Case Was Attributable To The Original Version of The SARS-CoV-2 Coronavirus That Emerged In Chinese City of Wuhan In Late 2019, While 57% of The Cases Were Caused by More Highly Transmissible So-Called "Variants of Concern".
▫️CureVac's U.S. Traded Shares Fell 50.6% To $46.81 In After-Hours Trading Following Publication of The Data.
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Ibuprofen Kills Pain Better Than Codeine With Fewer Side Effects, Study Finds
▫️Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Such As Ibuprofen Provide Better Pain Control And Have Fewer Adverse Effects Than Codeine, a Commonly Prescribed Opioid, When Prescribed After Outpatient Surgery, According To New Research Published In CMAJ (Canadian Medical Association Journal).
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▫️Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Such As Ibuprofen Provide Better Pain Control And Have Fewer Adverse Effects Than Codeine, a Commonly Prescribed Opioid, When Prescribed After Outpatient Surgery, According To New Research Published In CMAJ (Canadian Medical Association Journal).
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Oxford Covid-19 Vaccine Shows Effectiveness Against Delta Variant
▫️AstraZeneca Has Reported New Data Showing That Its Covid-19 Vaccine Provided Increased Levels of Protection Against The Delta Variant, B.1.617.2, Formerly Known As The "Indian Variant".
▫️The Vaccine Shows 92% And 86% Efficiency Against Hospitalization In Delta And Alpha Variant Cases, Respectively.
▫️Developed by The University of Oxford, Along With Vaccitech, The Vaccine Utilizes A Weakened Adenovirus And Has The SARS-CoV-2 Virus Spike Protein Genetic Material.
- On Vaccination, The Surface Spike Protein Is Generated, Which Prepares The Immune System To Fight SARS-CoV-2 on Contracting Covid-19.
▫️The New Real-World Data from Public Health England (PHE) Showed That Two doses of Covid-19 Vaccine Oxford-AstraZeneca Had 92% Efficiency Against Hospitalization In Delta Variant Cases.
▫️No Deaths Were Reported Among Those Inoculated With The Vaccine, The Company Noted.
▫️The Analysis Was Conducted on 14,019 Cases of The Delta Variant Observed Between 12 April And 4 June This Year In England.
▫️Furthermore, The Vaccine Was Effective Against The Alpha Variant Or B.1.1.7 And Decreased Hospitalisation by 86% With No Deaths Observed.
▫️The Data Also Showed That The Vaccine Had Lower Effectiveness Against Milder Symptomatic Covid-19. The Effectiveness Was 74% And 64% Against Symptomatic Disease by The Alpha And Delta Variants, Respectively.
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▫️AstraZeneca Has Reported New Data Showing That Its Covid-19 Vaccine Provided Increased Levels of Protection Against The Delta Variant, B.1.617.2, Formerly Known As The "Indian Variant".
▫️The Vaccine Shows 92% And 86% Efficiency Against Hospitalization In Delta And Alpha Variant Cases, Respectively.
▫️Developed by The University of Oxford, Along With Vaccitech, The Vaccine Utilizes A Weakened Adenovirus And Has The SARS-CoV-2 Virus Spike Protein Genetic Material.
- On Vaccination, The Surface Spike Protein Is Generated, Which Prepares The Immune System To Fight SARS-CoV-2 on Contracting Covid-19.
▫️The New Real-World Data from Public Health England (PHE) Showed That Two doses of Covid-19 Vaccine Oxford-AstraZeneca Had 92% Efficiency Against Hospitalization In Delta Variant Cases.
▫️No Deaths Were Reported Among Those Inoculated With The Vaccine, The Company Noted.
▫️The Analysis Was Conducted on 14,019 Cases of The Delta Variant Observed Between 12 April And 4 June This Year In England.
▫️Furthermore, The Vaccine Was Effective Against The Alpha Variant Or B.1.1.7 And Decreased Hospitalisation by 86% With No Deaths Observed.
▫️The Data Also Showed That The Vaccine Had Lower Effectiveness Against Milder Symptomatic Covid-19. The Effectiveness Was 74% And 64% Against Symptomatic Disease by The Alpha And Delta Variants, Respectively.
@MedicalNoteBook
Regeneron's Antibody Cocktail Saves Lives In Hospitalised Covid-19 Patients
▫️A Covid-19 Antibody Cocktail Developed by Regeneron Pharmaceuticals Inc And Roche Reduced Deaths In Hospitalised Patients Whose Own Immune Systems Had Failed To Produce A Response, A Large British Study At The University of Oxford Found on Wednesday.
▫️The Researchers Found That Regeneron’s REGEN-COV Reduced The Risk of 28-day Mortality by 20% In Patients Hospitalised With Covid-19 Who Had Not Mounted Their Own Immune Response And Tested Negative for Antibodies. These Patients Are Known As Seronegative.
▫️The Study Involved 9,785 Patients Hospitalised With Covid-19 In Hospitals Across The UK. One-Third Showed No Trace of Producing Their Own Antibodies. In This Seronegative Group, Mortality Was 30% Among Those Who Received Standard Clinical Care But Dropped to 24% Among Those Given An Intravenous Infusion of 8,000mg of REGEN-COV.
▫️REGEN-COV Is A Cocktail of Two Monoclonal Antibodies, Casirivimab With Imdevimab, Designed To Block The Infectivity of SARS-CoV-2. The Two Antibodies Work by Binding To Two Different Points on The Coronavirus Spike Protein, Neutralising The Ability of The Virus To Infect Cells.
▫️Previous Phase III Trials In Non-Hospitalised Covid-19 Patients Demonstrated That REGEN-COV “Reduced Viral Levels, Shortened The Time To Resolution of Symptoms And Significantly Reduced The Risk of Hospitalisation Or Death.”
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▫️A Covid-19 Antibody Cocktail Developed by Regeneron Pharmaceuticals Inc And Roche Reduced Deaths In Hospitalised Patients Whose Own Immune Systems Had Failed To Produce A Response, A Large British Study At The University of Oxford Found on Wednesday.
▫️The Researchers Found That Regeneron’s REGEN-COV Reduced The Risk of 28-day Mortality by 20% In Patients Hospitalised With Covid-19 Who Had Not Mounted Their Own Immune Response And Tested Negative for Antibodies. These Patients Are Known As Seronegative.
▫️The Study Involved 9,785 Patients Hospitalised With Covid-19 In Hospitals Across The UK. One-Third Showed No Trace of Producing Their Own Antibodies. In This Seronegative Group, Mortality Was 30% Among Those Who Received Standard Clinical Care But Dropped to 24% Among Those Given An Intravenous Infusion of 8,000mg of REGEN-COV.
▫️REGEN-COV Is A Cocktail of Two Monoclonal Antibodies, Casirivimab With Imdevimab, Designed To Block The Infectivity of SARS-CoV-2. The Two Antibodies Work by Binding To Two Different Points on The Coronavirus Spike Protein, Neutralising The Ability of The Virus To Infect Cells.
▫️Previous Phase III Trials In Non-Hospitalised Covid-19 Patients Demonstrated That REGEN-COV “Reduced Viral Levels, Shortened The Time To Resolution of Symptoms And Significantly Reduced The Risk of Hospitalisation Or Death.”
@MedicalNoteBook