Clinical Trials, Containment, Nurses and Protein

4 Life Science Trends To Pay Attention To in 2021

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science

Life Science Clinical Trials Clinical Trials Trials

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Marketing

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

Antibody

Antibody Production Manufacturing Clinical Trials

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Antibody

Antibody Medicine Production Trials

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Drugs

Drugs Licensing Licensing Production

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody

Antibody Trials Production Clinical Trials

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

JUNE 18, 2021

VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis. Concomitant use of preparations containing St. VENCLYXTO is being developed by AbbVie and Roche.

Medicine

Medicine HR Trials Production

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Drugs

Drugs Licensing Licensing Containment

Stoke Therapeutics Announces Presentations Related to the Company’s Work to Advance STK-001, the First Potential New Medicine to Target the Underlying Cause of Dravet Syndrome at the American Epilepsy Society (AES) 2020 Annual Meeting

The Pharma Data

DECEMBER 3, 2020

Clinical Trials. STK-001 is an investigational new medicine for the treatment of Dravet syndrome currently being evaluated in a Phase 1/2a clinical trial. protein expression by leveraging the non-mutant (wild-type) copy of the SCN1A gene to restore physiological Na V 1.1 Antiepileptic Drugs / 7B.

Medicine

Medicine Genetics Clinical Trials Clinical Trials

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Licensing

Licensing Licensing Drugs Manufacturing

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission.

Antibody

Antibody Production Clinical Trials Clinical Trials

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related.

Trials

Trials Allergies In-Vitro Antibody

AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

The Pharma Data

JUNE 18, 2021

BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. About VENCLYXTO ® (venetoclax) VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. Indications.

Trials

Trials Clinical Trials Clinical Trials Medicine

AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

The Pharma Data

APRIL 28, 2021

About the VENCLYXTO AML Clinical Trial Program AbbVie’s clinical trial program to evaluate VENCLYXTO combination therapy in patients with newly diagnosed acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy included two studies conducted around the world. and by AbbVie outside of the U.S.

Trials

Trials Medicine Clinical Trials Clinical Trials

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Antibody

Antibody Trials Clinical Trials Clinical Trials

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission.

Antibody

Antibody Production Clinical Trials Clinical Trials

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis. John’s?wort

Medicine

Medicine Production FDA Approval Trials

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

Medicine

Medicine Production FDA Approval Trials

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. of patients in clinical trials.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. of patients in clinical trials.

Trials

Trials Hormones Clinical Trials Clinical Trials

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

MAY 13, 2021

Fructose Containing Sugars at Normal Levels of Consumption Do Not Effect Adversely Components of the Metabolic Syndrome and Risk Factors for Cardiovascular Disease. based weight loss intervention in adults with obesity: A randomized clinical trial. Arq Gastroenterol. 2014 AprJun;51(2):118-22. PMID: 25003263. 2016;8(4):179.

Insulin

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COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein.

Vaccination

Vaccination Vaccine Antibody Life Science

Clinical Research Informer

4 Life Science Trends To Pay Attention To in 2021

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Trending Sources

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Stoke Therapeutics Announces Presentations Related to the Company’s Work to Advance STK-001, the First Potential New Medicine to Target the Underlying Cause of Dravet Syndrome at the American Epilepsy Society (AES) 2020 Annual Meeting

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Clinical Catch-Up: January 18-22 | BioSpace

AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

Let's Quit Sugar With Audiobook – Let's Quit Sugar

COVID-19 Pandemic Coverage

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