Drug Discovery World

FEBRUARY 7, 2024

Referencing the unmet potential for both genomic medicine, as well as the interest in cell-free DNA markers, particularly for early detection of cancers, he goes on to share the hopefulness that proteomics will do better.

Medicine 59

Medicine Protein FDA Approval DNA 59

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 52

Antibody Vaccination Vaccine Trials 52

XTalks

DECEMBER 24, 2020

From isolating SARS-CoV-2 in early January to sequencing its genome shortly thereafter and having a prototype vaccine against it within days, scientific process and progress have held steadfast throughout the pandemic. Most antibody drugs and vaccines have been developed to target parts of the spike protein. Drug Approvals.

Life Science 111

Life Science Vaccination Vaccine Gene 111

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 105

Vaccination Vaccine RNA Manufacturing 105

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals.

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Insulin Production Development Genetics 130

XTalks

NOVEMBER 7, 2022

These tumor-derived entities are used to derive genomic and proteomic data. 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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

MARCH 28, 2024

Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Tukysa (tucatinib) plus Herceptin (trastuzumab): The FDA has approved this treatment for certain individuals with CRC characterized by overexpression of HER2 proteins in their tumors.

Gene Editing 59

Gene Editing Life Science Clinical Trials Clinical Trials 59

Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. These therapeutics are complex and one of the major bottlenecks in their development is avoiding downstream impurities during manufacturing, which can cause major safety concerns.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

The Pharma Data

DECEMBER 10, 2020

The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. ImmunityBio’s hAd5 vaccine generated robust neutralizing antibody activity that was present 14 days post-final vaccination. This press release features multimedia. Graphic: Business Wire).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

MARCH 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. For all FDA-approved indications for ALIMTA, please see full Prescribing Information.

Research 52

Research Clinical Trials Clinical Trials Trials 52

pharmaphorum

SEPTEMBER 13, 2022

Further research led Ehrlich to develop his side-chain theory, that antibodies produced by white blood cells act as receptors on the cell membrane. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. 2002 – Emergence of CAR-T therapy.

Genome Project 94

Genome Project Genome Genomics DNA 94

The Pharma Data

JULY 8, 2021

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Containment Trials Genome 52

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. CAR T cells are T cells that have been trained to attack tumours.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

XTalks

DECEMBER 17, 2021

Initial lab studies, including one from South Africa, show that vaccine-induced antibodies may be less effective at neutralizing Omicron. Early lab data also shows that Omicron can be more effectively neutralized with three doses of the Pfizer vaccine, and that two doses provides only about 70 percent protection against hospitalization.

Life Science 98

Life Science Vaccination Vaccine Trials 98

The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] 1)] as determined by a U.S. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

MARCH 30, 2021

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Containment Trials Genome 52

Drug Discovery World

MAY 11, 2023

In these cases, injection of the viral vector vaccines induced the production of antibodies recognising platelet factor 4 (PF4) found on patients’ platelets 1. These assays require large quantities of high-affinity anti-HCP antibodies and still fail to cover the complete HCP profile.

Production 52

Production Gene Protein Vaccination 52

Pfizer

NOVEMBER 2, 2022

This is reminiscent of influenza, another respiratory disease that requires repeated vaccinations due to its genomic instability resulting in modifications of the surface protein hemagglutinin. Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

MARCH 23, 2021

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

HR 52

HR FDA Approval Containment Genome 52

Drug Discovery World

APRIL 17, 2023

New bispecific antibody study results for multiple myeloma According to results of a phase I/II clinical trial presented today, patients with relapsed or refractory multiple myeloma who were treated with the two highest doses of REGN5459, a bispecific antibody targeting BCMA and CD3, experienced a 90.5% Read more here. Read more here.

Research 52

Research Antibody Bioavailability Genetics 52

The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

Production 52

Production Branding Marketing Licensing 52

The Pharma Data

JULY 23, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. Secondary endpoints include safety and overall survival. About tiragolumab.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Embryo-Fetal Toxicity.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Embryo-Fetal Toxicity.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

MAY 5, 2021

India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines ( Endpoints ). CureVac says well on track to request vaccine approval as planned ( Reuters ) ( NYT ).

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52