Delveinsight

DECEMBER 7, 2020

In May 2020, Freenome initiated AI-EMERGE, a clinical study for the AI-Genomics blood test has been completed, which collected samples from up to 3,000 patients in the US and Canada. In May 2018, the firm received IDE approval for a trial, and in December 2019, it received the FDA’s Breakthrough Device designation.

Protein 56

Protein Insulin Hormones FDA Approval 56

The Pharma Data

JANUARY 17, 2021

We are pleased to announce this partnership with VHIO which will bring liquid biopsy comprehensive genomic testing to more cancer patients in Spain and beyond,” said Helmy Eltoukhy, Guardant Health CEO. Guardant Health has achieved CE mark approval as well as U.S. Forward-Looking Statements.

Genome 40

Genome Genomics Clinical Trials Clinical Trials 40

Camargo

DECEMBER 10, 2021

Biomarin’s stock shot up after the drug was first approved in the EU this past August, and on the day the news broke of the FDA approval, the stock improved 10.3%. Subsequent revisions of the document reflect the experience gained as gene therapy products of this type have been approved.

Development 176

Development Genetics Production Clinical Trials 176

XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Delveinsight

DECEMBER 13, 2020

In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir? Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. in January 2019.

Genotype 52

Genotype FDA Approval DNA Drugs 52

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

The Pharma Data

DECEMBER 10, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-Looking Statements. Forward-Looking Statements.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

JULY 8, 2021

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. 1) as determined by an FDA-approved test. Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval Containment Trials Genome 52

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is also indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for any platinum-containing chemotherapy.

FDA Approval 100

FDA Approval Containment Development Genome 100

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. The future of cell and gene therapies.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. . INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

Bacteria 278

Bacteria Trials Research Medicine 278

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 98

Manufacturing Gene Genome Genomics 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. Head and Neck Squamous Cell Cancer.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

OCTOBER 14, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-Looking Statements. Forward-Looking Statements.

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

MARCH 30, 2021

In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) ?10. 1] as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

MARCH 23, 2021

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. 1] as determined by an FDA-approved test. Head and Neck Squamous Cell Cancer.

HR 52

HR FDA Approval Containment Genome 52

Drug Discovery World

MAY 11, 2023

First, products containing undesired proteases can impair drug stability, either by degrading the drug itself or by degrading stabilising excipients of the drug formulation, which ultimately diminishes the drug’s durability. These host cells alone contain over a thousand HCPs. coli, and Pichia cells.

Production 52

Production Gene Protein Vaccination 52

The Pharma Data

JUNE 30, 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. Source link: [link].

Trials 52

Trials Genome Genomics Containment 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

APRIL 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 Immune Response Genome Genomics 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

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.

Immune Response 52

Immune Response Medicine Protein Gene 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

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. In certain countries outside the U.S.,

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. In certain countries outside the U.S.,

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52