Antibody, Clinical Development, Hormones and Trials

Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

Antibody

Antibody Marketing Drugs Licensing

Buparlisib hydrochloride by Adlai Nortye Biopharma for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 23, 2023

Buparlisib hydrochloride is under clinical development by Adlai Nortye Biopharma and currently in Phase II for Mantle Cell Lymphoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Hormones

Hormones Development Drugs Clinical Trials

The latest advances in breast cancer therapy

Drug Discovery World

DECEMBER 14, 2023

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients. “We

HR

HR Hormones Trials In-Vivo

Merck & Co buys cancer biotech VelosBio for $2.75bn

pharmaphorum

NOVEMBER 6, 2020

Its lead candidate in clinical development is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is being tested in a phase 1 and a phase 2 clinical trial for patients with blood cancer and solid tumours, respectively. The transaction is expected to close at the end of 2020.

Antibody

Antibody Hormones Trials Clinical Trials

Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All patients in the trial received a HER2 test, and the results were centrally confirmed. The data will be presented at a forthcoming medical meeting and shared with global health authorities.

HR

HR Trials Hormones Antibody

Risk adjusted net present value: What is the current valuation of Chinook Therapeutics’s Atrasentan Hydrochloride?

Pharmaceutical Technology

FEBRUARY 18, 2023

According to Globaldata, it is involved in 24 clinical trials, of which 19 were completed, 2 are ongoing, 1 is planned, and 2 were terminated. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Hormones

Hormones Production Development Clinical Trials

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) together With Chemotherapy surely Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative carcinoma Whose Tumors Express PD-L1 (CPS ?10)

The Pharma Data

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers through an in depth clinical development program for KEYTRUDA and a number of other other investigational and approved medicines across these areas. About Triple-Negative carcinoma.

Hormones

Hormones Medicine Clinical Research Research

Enough Of Wasting Away From Cancer: Companies Gear Up To Tackle Cachexia

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Earlier clinical evidence showcased administration of the therapy resulted in a statistically significant and dose-proportional increase in body weight.

Marketing

Marketing Pharma Companies Development Hormones

2020 review – Pharma’s progress outside of COVID-19

pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. months, compared with 6.7 months in patients treated with chemotherapy.

Marketing

Marketing Gene Silencing Gene Drugs

Big pharma vs small diseases: Tackling rare diseases

pharmaphorum

APRIL 28, 2022

Although they have, by definition, small addressable markets, the treatments cost just as many resources to develop as therapies for more common diseases – sometimes more, because of the added difficulty of finding sufficiently large patient populations for trials and finding disease experts to run them.

Pharma Companies

Pharma Companies Branding Development Marketing

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. We look forward to developing and advancing our differentiated pipeline of novel therapeutics in carefully selected disease areas.”.

In-Vivo

In-Vivo In-Vitro Antibody Development

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer.

HR

HR Medicine Hormones Trials

Japan grants approvals for Merck’s Keytruda to treat different cancers

Pharmaceutical Technology

SEPTEMBER 28, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted four new approvals for Merck ’s (MSD outside North America) humanised monoclonal antibody, Keytruda (pembrolizumab), to treat various types of cancers. This approval is based on KEYNOTE-564 trial data.

Antibody

Antibody Clinical Trials Clinical Trials Hormones

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review.

HR

HR FDA Approval Gene Trials

Merck Announces Third-Quarter 2020 Financial Results

The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. Frazier, chairman and chief executive officer, Merck. “I Financial Summary.

Sales

Sales Vaccination Vaccine Production

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

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

Sales Manufacturing FDA Approval Life Science

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Trials

Trials Hormones Clinical Trials Clinical Trials

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

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

Trials Hormones Genome Genomics

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

JULY 23, 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.

Hormones

Hormones Trials Genome Genomics

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

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

FDA Approval Containment Hormones Dermatology

BioSpace Global Roundup, Oct. 15

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. VBL is currently advancing its lead anti-MOSPD2 candidate through IND-enabling studies.

Clinical Trials

Clinical Trials Clinical Trials Manufacturing Trials

BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

The Pharma Data

DECEMBER 27, 2020

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R In pre-clinical studies, binding to Fc?R Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. R on macrophages.

Production

Production Drugs Clinical Trials Clinical Trials

Clinical Research Informer

Three trends in the antibody-drug conjugate (ADC) market

Buparlisib hydrochloride by Adlai Nortye Biopharma for Mantle Cell Lymphoma: Likelihood of Approval

Trending Sources

The latest advances in breast cancer therapy

Merck & Co buys cancer biotech VelosBio for $2.75bn

Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer

Risk adjusted net present value: What is the current valuation of Chinook Therapeutics’s Atrasentan Hydrochloride?

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) together With Chemotherapy surely Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative carcinoma Whose Tumors Express PD-L1 (CPS ?10)

Enough Of Wasting Away From Cancer: Companies Gear Up To Tackle Cachexia

2020 review – Pharma’s progress outside of COVID-19

Big pharma vs small diseases: Tackling rare diseases

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

Japan grants approvals for Merck’s Keytruda to treat different cancers

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

Merck Announces Third-Quarter 2020 Financial Results

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

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

BioSpace Global Roundup, Oct. 15

BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

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