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Pharmacology/Pharmaceutical Industry

RCT: Early treatment of Covid-19 with SARS-CoV-2 neutralizing antibody Sotrovimab is associated with reduced risk of hospitalization.

28 Oct, 2021 | 10:20h | UTC

Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab – New England Journal of Medicine

 

Commentary on Twitter

 


Merck to allow other nations to produce new COVID-19 antiviral.

28 Oct, 2021 | 10:18h | UTC

Merck to allow other nations to produce new COVID-19 antiviral – CIDRAP

See also:

Merck will allow drugmakers in other countries to make its COVID-19 pill – NPR

Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval – Health Policy Watch

Related:

Video: Merck’s Covid pill could transform treatment. Here’s how it works.

How antiviral pill Molnupiravir shot ahead in the COVID drug hunt.

What we know — and don’t know — about Merck’s new Covid-19 pill.

[Press release – not published yet] Merck announces oral antiviral Molnupiravir reduced the risk of hospitalization or death by approximately 50 Percent compared to placebo for patients with mild or moderate COVID-19.

Merck’s Covid-19 pill is great news but may not be a game-changer.

Video | A Pill For COVID? A Doctor Explains Molnupiravir.

 


RCT: Early treatment with fluvoxamine reduced the risk of emergency care and hospitalization among patients with COVID-19.

28 Oct, 2021 | 10:22h | UTC

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial – The Lancet Global Health

Commentaries:

Expert reaction to study looking at fluvoxamine as a COVID-19 treatment in high-risk outpatients with early-diagnosed COVID-19 – Science Media Centre

The TOGETHER Trial: COVID-19 and Fluvoxamine Take Two – REBEL EM

The antidepressant fluvoxamine can keep COVID-19 patients out of the hospital – ScienceNews

Related:

[Preprint] RCT: Fluvoxamine reduced the risk for ER visits and hospitalization among patients with Covid-19.

Opinion | Could this be our first effective, inexpensive, widely available outpatient treatment for COVID-19? (It’s fluvoxamine).

Preliminary study shows fluvoxamine may reduce clinical deterioration in outpatients with symptomatic COVID-19

 

Commentary on Twitter

 


What COVID vaccines for young kids could mean for the pandemic.

28 Oct, 2021 | 10:15h | UTC

What COVID vaccines for young kids could mean for the pandemic – Nature

Related: FDA advisory panel recommends Pfizer Covid-19 vaccine be authorized for children ages 5 to 11.

 


RCT: A geriatric assessment–driven intervention can reduce chemotherapy-related toxic effects in older adults with cancer.

28 Oct, 2021 | 09:50h | UTC

Geriatric Assessment–Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial – JAMA Oncology (link to abstract – $ for full-text)

Commentary: Older adults receiving additional supportive care services experience fewer side effects from chemotherapy – City of Hope National Medical Center

 

Commentary on Twitter

 


FDA advisory panel recommends Pfizer Covid-19 vaccine be authorized for children ages 5 to 11.

27 Oct, 2021 | 01:48h | UTC

FDA advisory panel recommends Pfizer Covid-19 vaccine be authorized for children – STAT

See also:

Tracking the FDA advisory panel meeting on Covid-19 vaccines for kids – STAT

FDA advisory panel recommends Pfizer vaccine for kids ages 5 to 11 – NPR

 


Mix-and-match COVID vaccines ace the effectiveness test – “No need for brand loyalty”.

27 Oct, 2021 | 01:42h | UTC

Mix-and-match COVID vaccines ace the effectiveness test – Nature

Related:

Cohort Study: The effectiveness of heterologous AstraZeneca (AZ)/mRNA prime-boost vaccination was more significant (68%) compared to the effectiveness of homologous AZ/AZ vaccination (50%) against symptomatic Covid-19 infection in Sweden.

Should You Mix and Match Your Booster Shot?

Study evaluated several heterologous SARS-CoV-2 vaccine regimens; no efficacy data but there was increased antibody production on study days 15 and 29 after booster shots from Moderna and Pfizer.

A primer on what we know about mixing and matching Covid vaccines.

Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination.

RCT: Safety and immunogenicity of heterologous vs. homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine.

Another study shows increased immune response with heterologous Oxford-AstraZeneca/mRNA vaccination.

Heterologous Oxford–AstraZeneca and Moderna Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

Heterologous Oxford–AstraZeneca and BioNTech/Pfizer Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

[Preprint] Mixing Covid jabs has good immune response, study finds – “The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other. All combinations worked well, priming the immune system”.

Phase 2 RCT: Immunogenicity and reactogenicity of a Pfizer-BioNTech booster in patients that have received a single dose of AstraZeneca vaccine – “BNT162b2 (Pfizer) given as a second dose in individuals prime vaccinated with ChAdOx1-S (AstraZeneca) induced a robust immune response, with an acceptable and manageable reactogenicity profile”.

Lab study shows heterologous AstraZeneca/Pfizer vaccination produces strong immune response against SARS-CoV-2 Delta variant.

Lab study shows a heterologous AstraZeneca + Pfizer immunization strategy provides stronger immunogenicity against Covid compared to homologous AZ + AZ or Pfizer + Pfizer strategies.

RCT: Mixing 2 different Covid vaccines is associated with increased risk of side effects.

 


Heterologous AstraZeneca/Pfizer vaccination seems to be associated with increased effectiveness against Covid-19 compared to homologous Pfizer/Pfizer vaccination.

27 Oct, 2021 | 01:44h | UTC

Immunogenicity and efficacy of heterologous ChadOx1/BNT162b2 vaccination – Nature

Related:

Cohort Study: The effectiveness of heterologous AstraZeneca (AZ)/mRNA prime-boost vaccination was more significant (68%) compared to the effectiveness of homologous AZ/AZ vaccination (50%) against symptomatic Covid-19 infection in Sweden.

Should You Mix and Match Your Booster Shot?

Study evaluated several heterologous SARS-CoV-2 vaccine regimens; no efficacy data but there was increased antibody production on study days 15 and 29 after booster shots from Moderna and Pfizer.

A primer on what we know about mixing and matching Covid vaccines.

Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination.

RCT: Safety and immunogenicity of heterologous vs. homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine.

Another study shows increased immune response with heterologous Oxford-AstraZeneca/mRNA vaccination.

Heterologous Oxford–AstraZeneca and Moderna Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

Heterologous Oxford–AstraZeneca and BioNTech/Pfizer Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

[Preprint] Mixing Covid jabs has good immune response, study finds – “The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other. All combinations worked well, priming the immune system”.

Phase 2 RCT: Immunogenicity and reactogenicity of a Pfizer-BioNTech booster in patients that have received a single dose of AstraZeneca vaccine – “BNT162b2 (Pfizer) given as a second dose in individuals prime vaccinated with ChAdOx1-S (AstraZeneca) induced a robust immune response, with an acceptable and manageable reactogenicity profile”.

Lab study shows heterologous AstraZeneca/Pfizer vaccination produces strong immune response against SARS-CoV-2 Delta variant.

Lab study shows a heterologous AstraZeneca + Pfizer immunization strategy provides stronger immunogenicity against Covid compared to homologous AZ + AZ or Pfizer + Pfizer strategies.

RCT: Mixing 2 different Covid vaccines is associated with increased risk of side effects.

 

Commentary on Twitter

 


Opinion | We Need to Ground Truth Assumptions about Gene Therapy – “Researchers, practitioners and patients must balance the discipline’s promise with its reality”.

27 Oct, 2021 | 01:21h | UTC

We Need to Ground Truth Assumptions about Gene Therapy – Nature

 


Anticoagulants and diabetes agents are among the most frequent causes of emergency department visits attributed to medication harms.

27 Oct, 2021 | 01:15h | UTC

US Emergency Department Visits Attributed to Medication Harms, 2017-2019 – JAMA (link to abstract – $ for full-text)

Commentaries:

Number of emergency room visits for medication harms increases with age – MedicalResearch.com

Blood thinners, diabetes meds among top causes of drug-related ER visits – UPI

 


Systematic Review: Antibiotics for the treatment of COVID‐19 – “We are certain that risk of death in hospitalized COVID‐19 patients is not reduced by treatment with azithromycin after 28 days”.

26 Oct, 2021 | 02:07h | UTC

Antibiotics for the treatment of COVID‐19 – Cochrane Library

 

Commentary on Twitter

 


RCT: Ozanimod as induction and maintenance therapy for ulcerative colitis.

27 Oct, 2021 | 01:19h | UTC

Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis – New England Journal of Medicine

 

Commentary on Twitter

 


[Press release – not published yet] Moderna says its COVID vaccine produced a strong antibody response for kids 6 to 11.

26 Oct, 2021 | 02:06h | UTC

Press release: Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age

Commentary: Moderna says new data supports its COVID vaccine for kids 6 to 11 – NPR

 


Pragmatic randomized trial found similar rates of surgical site infectious with 2% alcoholic chlorhexidine skin preparation compared with povidone–iodine, or with triclosan-coated sutures compared with non-coated sutures.

26 Oct, 2021 | 01:52h | UTC

Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial – The Lancet

Commentaries:

Prevention of surgical site infection in low-resource settings – The Lancet

Urgent changes needed to global guidelines designed to stop surgical infection – University of Birmingham

 

Commentary on Twitter

 


Infection with Covid-19 carries a much higher risk of developing neurological complications than Covid-19 vaccines.

26 Oct, 2021 | 02:04h | UTC

News Release: Infection with Covid-19 carries a much higher risk of developing neurological complications than a vaccine, says new study – University of Nottingham

Original Study: Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection – Nature Medicine

Commentaries:

Covid: Vaccine study links virus to rare neurological illness – BBC

Expert reaction to study looking at rare neurological complications after SARS-CoV-2 infection and COVID-19 vaccination – Science Media Centre

 

Commentary on Twitter

 


What It Means To Be Fully Vaccinated.

26 Oct, 2021 | 01:57h | UTC

What It Means To Be Fully Vaccinated – Think Global Health

 


Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study.

26 Oct, 2021 | 01:26h | UTC

Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study – European Heart Journal

Editorial: QT prolongation and cancer therapeutics: a coming Tempest or Much Ado About Nothing?

Commentary: Anticancer Drug-Induced Life-Threatening Ventricular Arrhythmias – American College of Cardiology

Related: AHA Scientific Statement: Recognition, prevention, and management of arrhythmias and autonomic disorders in cardio-oncology.

 

Commentary on Twitter

 


Opinion | COVID STEROID-2: Double the steroid, double the fun? – “Dexamethasone 6 mg/day alone is likely suboptimal for most patients with severe COVID pneumonia. Dexamethasone 12 mg/day may provide a reasonable intensity of immunomodulation”.

25 Oct, 2021 | 00:01h | UTC

COVID STEROID-2: Double the steroid, double the fun? – PulmCrit

Original study: RCT: In adults with Covid-19 and severe hypoxemia, 12 mg vs. 6 mg of Dexamethasone did not result in a statistically significant difference in the number of days alive without life support.

 

Commentary on Twitter

 


Half doses, third doses, kids’ doses: Covid vaccine delivery goes next-level difficult.

24 Oct, 2021 | 23:52h | UTC

Half doses, third doses, kids’ doses: Covid vaccine delivery goes next-level difficult – STAT

 


AstraZeneca vaccination not linked to reduced fertility rates and adverse birth outcomes.

24 Oct, 2021 | 23:58h | UTC

Fertility rates and birth outcomes after ChAdOx1 nCoV-19 (AZD1222) vaccination – The Lancet

Related:

A case-controlled study showed Covid-19 vaccination during early pregnancy was not associated with increased risk of first-trimester miscarriage.

Editorial: Covid-19 treatments and vaccines must be evaluated in pregnancy.

Cohort study: Vaccinated pregnant patients had 90% lower risk of severe or critical Covid-19 compared with unvaccinated pregnant patients.

Two observational studies suggest spontaneous abortion is not increased following COVID-19 mRNA vaccination during pregnancy.

Study shows high effectiveness of the Pfizer mRNA COVID-19 vaccine in pregnancy.

5 Crucial Things to Know About COVID-19 Vaccines and Pregnancy.

CDC Guidance: Pregnant people should be vaccinated against COVID-19.

ACOG and SMFM Recommend COVID-19 Vaccination for Pregnant Individuals – “ACOG encourages its members to enthusiastically recommend vaccination to their patients.”

Cohort study: Pfizer/BioNTech COVID vaccine associated with 78% lower risk of Covid-19 in pregnancy.

 

Commentary on Twitter

 


RCT: The association of Varenicline and Nicotine patch was not better than Varenicline alone to increase smoking abstinence; there was also no difference between 24-week vs. 12-week treatment courses in abstinence rates.

24 Oct, 2021 | 23:45h | UTC

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Is There a Role for Combined Use of Varenicline and Nicotine Patch or Extended Treatment Duration to Enhance Smoking Cessation? – JAMA (free for a limited period)

Commentary: Varenicline Combo, Extension No Better for Quitting Smoking – HealthDay

 

Commentary on Twitter

 


The cost-effectiveness of cefazolin compared to anti-staphylococcal penicillins for the treatment of methicillin-sensitive Staphylococcus aureus bacteremia.

24 Oct, 2021 | 23:41h | UTC

The cost-effectiveness of cefazolin compared to anti-staphylococcal penicillins for the treatment of methicillin-sensitive Staphylococcus aureus bacteremia – Open Forum of Infectious Diseases

Related:

Meta-Analysis: Cefazolin vs. Anti-staphylococcal Penicillins for the Treatment of Staphylococcus aureus Bacteremia

Meta-Analysis: Cefazolin vs. Antistaphylococcal Penicillins for MSSA Bacteremia

 

Commentaries on Twitter

 


M-A: In patients with Staphylococcus aureus bacteremia, combination therapy does not reduce mortality and is associated with increased risks of adverse events.

24 Oct, 2021 | 23:42h | UTC

The Effect of Combination Therapy on Mortality and Adverse Events in Patients with Staphylococcus aureus Bacteraemia: A Systematic Review and Meta-analysis of Randomized Controlled Trials – Infectious Diseases and Therapy

 


[Press release – not published yet] A phase 3 trial with more than 10,000 participants showed a booster dose of the Pfizer/BioNTech vaccine had an efficacy of 95.6% against disease; there were 5 cases in the booster group and 109 cases in the non-boosted group, not classified according to severity.

22 Oct, 2021 | 10:34h | UTC

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine

Commentary: Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say – CNN

 

Commentaries on Twitter

 


RCT: Mirtazapine not better than placebo for the treatment of agitation in people with dementia and was possibly associated with increased mortality (7 vs.1 deaths, difference not statistically significant; p=0·065).

22 Oct, 2021 | 10:19h | UTC

Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial – The Lancet

Commentary: Common antidepressant should no longer be used to treat people with dementia – University of Exeter

 


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