2019, FDA Approval, Immune Response and Therapies

Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares. . Over-the-counter treatments fail due to the body’s natural protective system.

FDA

FDA Disease Treatment FDA Approval

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

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Licensing

Licensing Licensing Vaccine FDA Approval

Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

Clinical Trials

Clinical Trials Research Science Clinical Research

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). Testing Therapies, Antivirals and Vaccines. The approval marks the first drug approved by the U.S.

Vaccine

Vaccine FDA Approval FDA 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 Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019. Wu J, Zhang M & Liu D.

Trials

Trials Clinical Trials Immune Response FDA Approval

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. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. futility analysis). . In the U.S.

Hospitals

Hospitals Trials Clinical Trials Production

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

Therapies

Therapies Production Clinical Trials Treatment

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

If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. , Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

Hospitals

Hospitals Production Clinical Trials Virus

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Vaccine

Vaccine Clinical Trials Licensing Licensing

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

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. About ImmunityBio ImmunityBio, Inc.

Vaccine

Vaccine Trials FDA Clinical Trials

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Vaccine

Vaccine Trials Clinical Trials Therapies

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

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Virus

Virus Trials Clinical Trials Production

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.,

Therapies

Therapies FDA Clinical Trials Hospitals

Iptacopan

New Drug Approvals

DECEMBER 16, 2023

3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immune responses against pathogens. April 2019). 1] It is a complement factor B inhibitor that was developed by Novartis. [1]

FDA

FDA Small Molecule FDA Approval Treatment

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. Food and Drug Administration (FDA). Regeneron Pharmaceuticals, Inc.

FDA

FDA Clinical Trials Hospitals Government

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

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies

Therapies Trials Disease Treatment

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . Neurology and Immunology.

Vaccine

Vaccine Production FDA FDA Approval

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

. An overall response rate of 23.5% 8 patients achieved confirmed response, including 1 complete response and 7 partial responses (according to RECIST 1.1). Responses were observed in all primary tumor types and across all lines of prior therapy. months versus 0% and a PFS of 1.4

Vaccine

Vaccine Virus Trials Treatment

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

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. About Opdivo.

Treatment

Treatment Trials Therapies Clinical Trials

Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

Vaccine

Vaccine FDA Small Molecule Immune Response

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Unfortunately, they can also trigger immune responses, and they are not super efficient at gene-editing some parts of the brain. These ribonucleoproteins also caused a lower immune response compared to the viruses, and are much easier to make in the lab. Malaria mortality from 2000 (left) to 2019 (right).

Vaccine

Vaccine DNA Virus Engineering

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon

APRIL 23, 2023

Unfortunately, they can also trigger immune responses, and they are not super efficient at gene-editing some parts of the brain. These ribonucleoproteins also caused a lower immune response compared to the viruses, and are much easier to make in the lab. Malaria mortality from 2000 (left) to 2019 (right).

Vaccine

Vaccine DNA Virus Engineering

Drug Discovery Digest

Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

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

Trending Sources

Who are the AACR Scientific Achievement Award winners?

Biopharma Update on the Novel Coronavirus: October 27

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

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

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

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

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

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

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

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

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

Iptacopan

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

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

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

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

Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

Codon Digest: Ghana Approves A Better Malaria Vaccine

Codon Digest: Ghana Approves A Better Malaria Vaccine

Stay Connected