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 52

Clinical Trials Clinical Trials Antibody Trials 52

XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Nizoral is prescribed off-label, while the others are FDA approved.

Trials 98

Trials Gene Hormones Clinical Trials 98

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

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. Civica JAAQ Sanofi.

Insulin 130

Insulin Production Development Genetics 130

STAT News

NOVEMBER 18, 2022

The first therapy that delays the onset of type 1 diabetes received approval from the U.S. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield and is from ProventionBio and Sanofi, is given through intravenous infusion. Food and Drug Administration , CNN tells us. As of 2019, about 1.9

Insulin 98

Insulin FDA Approval Production Pharmacy 98

XTalks

AUGUST 30, 2024

The acquisition of V-Wave strengthens its cardiovascular portfolio, while US Food and Drug Administration (FDA) submissions for Spravato (esketamine) as a monotherapy for adults with treatment-resistant depression and nipocalimab for antibody-positive generalized myasthenia gravis signal its commitment to addressing unmet medical needs.

Marketing 98

Marketing Production Sales Antibody 98

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

FDA Approval 52

FDA Approval Antibody DNA Hormones 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 Genomics Genome 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

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The design of the immune biologic puts these elements together on an antibody scaffold. Image from Cue Biopharma.

Protein 98

Protein Engineer Immune Response In-Vivo 98

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. Initiate treatment with insulin as clinically indicated. after the Selected Important Safety Information.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98