Containment, FDA Approval, Protein and RNA - Clinical Research Informer

Wainua (Eplontersen) Now FDA-Approved for Rare Disease ATTRv-PN

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

FDA Approval

FDA Approval Protein RNA Clinical Trials

Izervay Becomes Second FDA-Approved Drug for Geographic Atrophy

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor. How Does Izervay Work?

FDA Approval

FDA Approval Drugs Clinical Trials Clinical Trials

Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Immune Response

Immune Response Vaccination Vaccine FDA Approval

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

Vaccination

Vaccination Vaccine Manufacturing Containment

Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well?

Delveinsight

DECEMBER 13, 2020

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. in January 2019.

Genotype

Genotype FDA Approval DNA Drugs

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein.

Vaccination

Vaccination Vaccine Production Manufacturing

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. ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.

Vaccination

Vaccination Vaccine Immune Response Protein

Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

Manufacturing

Manufacturing Vaccination Vaccine RNA

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

The Pharma Data

NOVEMBER 16, 2020

Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. CAMBRIDGE, Mass.–(BUSINESS

Vaccination

Vaccination Vaccine Containment Pharmacy

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

The Pharma Data

NOVEMBER 16, 2020

I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. CAMBRIDGE, Mass.–(BUSINESS

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Improving quality control for CAR T cell therapies

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

Manufacturing

Manufacturing Gene Genome Genomics

What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccination

Vaccination Vaccine RNA Manufacturing

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales

Sales Manufacturing FDA Approval Life Science

Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland

The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. CAMBRIDGE, Mass.–(BUSINESS

Vaccination

Vaccination Vaccine Manufacturing Containment

European Commission Authorizes COVID-19 Vaccine Moderna in Europe

The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. About Moderna.

Vaccination

Vaccination Vaccine Medicine Containment

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

NOVEMBER 2, 2022

The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach. Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection. COMIRNATY® (COVID-19 Vaccine, mRNA).

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Clinical Research Informer

Wainua (Eplontersen) Now FDA-Approved for Rare Disease ATTRv-PN

Izervay Becomes Second FDA-Approved Drug for Geographic Atrophy

Trending Sources

Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

The Utility of Liquid Biopsy in Oncology Clinical Trials

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well?

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

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

Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

Improving quality control for CAR T cell therapies

What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland

European Commission Authorizes COVID-19 Vaccine Moderna in Europe

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Stay Connected