XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. Acromegaly. Prevalence: 50 to 70 people per 1 million.

Trials 98

Trials Gene Hormones Clinical Trials 98

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Monoclonal antibodies (mAbs). Blood and blood components. Allergenics. Somatic cells. Gene and cellular therapies. Recombinant therapeutic proteins. Growth factors. Fusion proteins.

Development 180

Development Protein Production Hormones 180

pharmaphorum

JANUARY 10, 2023

The report also says late-stage rivals from Eli Lilly (donanemab) and possibly Roche (gantenerumab) may follow suit pending the results of ongoing trials; 7) Lenacapavir : Gilead Sciences’ first-in-class capsid inhibitor makes the grade for its potential to transform the treatment of HIV thanks to a twice-yearly dosing regimen.

Drugs 52

Drugs Gene Therapy Insulin Antibody 52

The Pharma Data

AUGUST 17, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells. billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 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. confirmatory trial for the accelerated approval. in these patients.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types.

Trials 52

Trials Hormones Genome Genomics 52