Antibody, Clinical Trials, FDA Approval and Immune Response

FDA approves Covid-19 mAb for emergency use in immunocompromised

Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

FDA Approval

FDA Approval Antibody Clinical Trials Clinical Trials

STAT+: Pharmalittle: FDA approves a Genentech blood-cancer drug; Sean Parker expands his immunotherapy research empire

STAT News

DECEMBER 23, 2022

The new drug, called Lunsumio, is a so-called bispecific antibody, which works by attaching to cancer cells with one arm of the drug, and T cells with a second arm. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response.

FDA Approval

FDA Approval Immune Response Drugs Research

Potentially ‘regenerative’ osteoarthritis drug moves to clinical trial

Drug Discovery World

APRIL 3, 2023

The findings indicate that a drug compound, R805/CX-011, may modulate an important cell receptor in the body’s immune system, GP130, that signals when antibodies should attack a virus or infection. The post Potentially ‘regenerative’ osteoarthritis drug moves to clinical trial appeared first on Drug Discovery World (DDW).

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Regeneron’s Antibody Drug Becomes First Approved Treatment for Ebola

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus. Targeted Antiviral Treatment.

Antibody

Antibody Drugs Clinical Trials Clinical Trials

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval

FDA Approval Manufacturing In-Vivo Trials

World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

FDA Approval

FDA Approval Gene Therapy Clinical Trials Clinical Trials

Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) of Beth Israel Deaconess Medical Center suggest maturation of B-cell response without further boosting. 1.1.7), Beta (B.1.351),

Immune Response

Immune Response Medicine Vaccination Vaccine

Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. Related: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic.

Insulin

Insulin Drugs FDA Approval Immune Response

Pfizer’s RSV Vaccine Abrysvo Is a New Step for RSV Prevention

XTalks

JUNE 5, 2023

Abrysvo functions as a vaccine by triggering an immune response specifically aimed at RSV preF, which provides protection against RSV-induced LRTD. Safety and Efficacy of Abrysvo The FDA’s approval of Abrysvo is supported by compelling clinical evidence. percent and severe RSV-associated LRTD by 94.1

Vaccination

Vaccination Vaccine FDA Approval Protein

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

mRNA Cancer Vaccines and Therapies: An Overview

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination

Vaccination Vaccine Protein Antibody

U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

FDA Approval

FDA Approval Vaccination Vaccine Licensing

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

Development

Development Production Immune Response Licensing

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

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis).

Antibody

Antibody Trials Production Clinical Trials

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

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

Antibody

Antibody Production Clinical Trials Clinical Trials

Novavax COVID-19 Vaccine Gets Recommended for FDA Emergency Use Authorization

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. Clinical Trial Results.

Vaccination

Vaccination Vaccine Immune Response Protein

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

XTalks

MAY 1, 2023

Today marks an important moment in ALS research as Qalsody is the first ALS treatment approved based on a biomarker,” said Jean Swidler, chair of Genetic ALS & FTD: End the Legacy, in Biogen’s press release. In recent years, several other medications have entered Phase II/III clinical trials for the treatment of ALS.

FDA Approval

FDA Approval Gene Genetics Protein

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

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

Antibody

Antibody Medicine Production Trials

FDA Expands Stelara (ustekinumab) Indication to Treat Pediatric Patients with Active Psoriatic Arthritis

XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. The featured speakers will discuss how to facilitate trial participation in rare disease.

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. At six months, 29.5

Vaccination

Vaccination Vaccine Immune Response Trials

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Licensing

Licensing Licensing Vaccination Vaccine

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. and globally.”.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.

Antibody

Antibody Vaccination Vaccine Manufacturing

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

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

Antibody

Antibody Production Clinical Trials Clinical Trials

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

Antibody

Antibody Trials Production Clinical Trials

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

Vaccination

Vaccination Vaccine Immune Response Protein

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

Antibody

Antibody Vaccination Vaccine Trials

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

NOVEMBER 30, 2020

In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development

Clinical Development Vaccination Vaccine Development

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

AUGUST 16, 2021

The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”. In the U.S.,

Vaccination

Vaccination Vaccine Immune Response Antibody

Regeneron’s Evkeeza (evinacumab) Reduces Cholesterol Levels in Children with Homozygous Familial Hypercholesterolemia (HoFH) in Phase III Trial

XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Ongoing and Future Studies.

Trials

Trials Antibody Genetics Gene

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units.

Vaccination

Vaccination Vaccine Antibody Protein

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.

Vaccination

Vaccination Vaccine Protein Immune Response

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

Vaccination

Vaccination Vaccine Immune Response Protein

What Innovative Treatments For Metastatic Breast Cancer are being developed?

Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. In phase II clinical trial, led by Steven A.

Development

Development DNA Clinical Trials Clinical Trials

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History.

Trials

Trials Clinical Trials Clinical Trials Immune Response

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval

FDA Approval Containment Hormones Dermatology

Pfizer Shares Positive Data on COVID-19 Vaccine for Young Children, But How Willing Are Parents to Vaccinate Their Kids?

XTalks

SEPTEMBER 23, 2021

NYSE: PFE ) and BioNTech SE ( Nasdaq: BNTX ) announced the very first results from a pivotal trial being conducted for their COVID-19 vaccine for children on Monday. The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old. Pfizer Inc.

Vaccination

Vaccination Vaccine Trials Antibody

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Monoclonal Antibodies. The human monoclonal antibody targets specific immune plasma cells. The cells secrete auto-antibodies, but do not respond to standard immunosuppression.

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Systemic Lupus Erythematosus Treatment Market: How the Leading Companies are Countering the Rising Prevalence?

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. The average annual drug cost is USD 38,000 per year.

Marketing

Marketing Sales FDA Approval Antibody

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits.

The Pharma Data

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Mini Oral Session – Melanoma and Other Skin Tumours. Early Development.

Research

Research Immune Response Antibody Trials

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The Pharma Data

AUGUST 17, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Immune Response

Immune Response Trials Medicine FDA Approval

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. Immune system modulators (i.e.

Protein

Protein Engineer Immune Response In-Vivo

GSK and Alector announce global collaboration in immuno-neurology

The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. There are multiple heritable forms of FTD.

Genetics

Genetics Gene Antibody Development

FDA approves Covid-19 mAb for emergency use in immunocompromised

STAT+: Pharmalittle: FDA approves a Genentech blood-cancer drug; Sean Parker expands his immunotherapy research empire

Trending Sources

Potentially ‘regenerative’ osteoarthritis drug moves to clinical trial

Regeneron’s Antibody Drug Becomes First Approved Treatment for Ebola

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

World AIDS Day 2023: New and Promising Treatments for HIV/AIDS

Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

Pfizer’s RSV Vaccine Abrysvo Is a New Step for RSV Prevention

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

mRNA Cancer Vaccines and Therapies: An Overview

U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

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

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

Novavax COVID-19 Vaccine Gets Recommended for FDA Emergency Use Authorization

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

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

FDA Expands Stelara (ustekinumab) Indication to Treat Pediatric Patients with Active Psoriatic Arthritis

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

Biopharma Update on the Novel Coronavirus: October 27

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

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

Novavax Announces COVID-19 Vaccine Clinical Development Progress

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

Regeneron’s Evkeeza (evinacumab) Reduces Cholesterol Levels in Children with Homozygous Familial Hypercholesterolemia (HoFH) in Phase III Trial

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

What Innovative Treatments For Metastatic Breast Cancer are being developed?

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Pfizer Shares Positive Data on COVID-19 Vaccine for Young Children, But How Willing Are Parents to Vaccinate Their Kids?

Advances in the Battle Against Autoimmune Disease

Systemic Lupus Erythematosus Treatment Market: How the Leading Companies are Countering the Rising Prevalence?

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits.

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

GSK and Alector announce global collaboration in immuno-neurology

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