Pharmaceutical Technology

MARCH 6, 2023

New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting. months for the chemotherapy arm (hazard ratio [HR]: 0.52). At a median follow-up of 22.1 months versus 8.2

HR 130

HR FDA Approval Licensing Licensing 130

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.

HR 52

HR Hormones Trials In-Vivo 52

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. All patients in the trial received a HER2 test, and the results were centrally confirmed.

HR 52

HR Trials Hormones Antibody 52

The Pharma Data

APRIL 27, 2022

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.

HR 52

HR Trials Protein Medicine 52

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

Drug Discovery World

JUNE 2, 2023

With National Cancer Research Month coming to an end and the American Society of Clinical Oncology Annual Meeting currently taking place in Chicago (2-6 June), it’s been another busy week for cancer drug development news.

Drugs 52

Drugs HR Antibody Clinical Trials 52

pharmaphorum

OCTOBER 12, 2022

The US regulator has granted a priority review for Trodelvy (sacituzumab govitecan) as a treatment for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on endocrine-based therapy and at least two additional systemic therapies, based on the results of the recently-reported TROPiCs-02 trial.

HR 52

HR Sales Hormones Antibody 52

pharmaphorum

SEPTEMBER 9, 2022

At this year’s ASCO congress, news that Trodelvy (sacituzumab govitecan) failed to have a significant impact on overall survival (OS) in this form of breast cancer weighed heavily on Gilead, as the Trop2-targeting antibody-drug conjugate (ADC) is central to its plans to grow in oncology.

HR 52

HR Hormones Trials Sales 52

The Pharma Data

MARCH 22, 2023

targeted monoclonal antibody, plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) versus placebo plus CAPOX in patients with CLDN18.2-positive, Senior Vice President and Head of Development Therapeutic Areas, Astellas. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Median PFS was 8.21

Trials 40

Trials HR Development Clinical Development 40

Drug Discovery World

JANUARY 9, 2024

2024 is anticipated to be a transformational year for the pharma industry, with new modalities like antibody drug conjugates and AI/machine learning providing therapies for patients with limited treatment options.

Drugs 69

Drugs Gene Editing Antibody Medicine 69

pharmaphorum

SEPTEMBER 15, 2020

The agreement with Immunommedics adds Trodelvy (sacituzumab govitecan) to Gilead’s pipeline, a first-in-class TROP2 antibody-drug conjugate drug. While Trodelvy currently has no direct competitors in its class, AstraZeneca and Daiichi Sankyo have this year inked a deal worth up to $6 billion to develop a rival TROP2 drug.

Trials 82

Trials HR Drugs Sales 82

The Pharma Data

JANUARY 14, 2021

HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027. HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027.

Trials 52

Trials HR Containment Development 52

XTalks

MAY 2, 2024

billion After Biogen and Eisai’s Aduhelm (aducanumab) and Leqembi (lecanemab), donanemab is Eli Lilly’s answer in the beta-amyloid-lowering class of monoclonal antibodies. The companies followed it up with a second BLA submission in patients with HR+, HER2– breast cancer that has been previously treated with systemic therapy.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

XTalks

SEPTEMBER 17, 2020

Gilead Sciences has offered to buy biotech company Immunomedics for $21 billion in a bid to strengthen its cancer drug development pipeline. Trodelvy is being studied in an ongoing Phase III trial as third line treatment for HR+/HER2- breast cancer and a Phase II study in bladder cancer. Trodelvy is an antibody-drug conjugate (ADC).

HR 72

HR Medicine Licensing Licensing 72

XTalks

MARCH 22, 2021

And as big pharma works on developing and growing their oncology portfolios, the rising trend of such mergers and acquisitions won’t be slowing down any time soon. Resolution has been a leader in the development of NGS-based companion diagnostics (CDx) test development and registration services for precision oncology.

Life Science 110

Life Science Development Marketing Gene Expression 110

The Pharma Data

NOVEMBER 18, 2021

The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); 0.87); p = 0.0010) compared to placebo. 0.87); p = 0.0010).

FDA Approval 52

FDA Approval HR Trials Drugs 52

The Pharma Data

JUNE 25, 2021

41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; After a median follow-up of 24.1 months (14.9-41.5), 0.87]; p=0.0010). 0.96]; p=0.0164). KEYTRUDA is currently approved in the U.S., 0.87]; p=0.0010).

HR 52

HR Trials Clinical Research Research 52

The Pharma Data

MARCH 2, 2021

executive vice president of Research and Development at Amgen. Key secondary endpoints included overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. Reese, M.D., respectively. Source link:[link].

HR 52

HR Trials Antibody Development 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

HR 162

HR Marketing Hormones FDA Approval 162

The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; ENSPRYNG was recently approved by the U.S.

Antibody 52

Antibody Medicine HR In-Vitro 52

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Roche’s Chief Medical Officer and Head of Global Product Development. “As SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth and early development of metastatic disease.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

MARCH 17, 2021

KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; In KEYNOTE-204, KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; 0.88]; p=0.0027) and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV. months (95% CI, 10.9-19.4)

HR 52

HR Trials Antibody Clinical Research 52

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. receptors.

HR 52

HR Medicine In-Vitro Development 52

The Pharma Data

APRIL 20, 2023

Roche’s Chief Medical Officer and Head of Global Product Development. The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP (n=440) compared with R-CHOP (n=439; hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; 0.95; p<0.02). versus 57.5%), serious AEs (34.0% versus 13.0%).

FDA Approval 40

FDA Approval HR Antibody Drugs 40

The Pharma Data

MARCH 7, 2022

Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Gilead Sciences, Inc.

HR 52

HR Hormones Medicine Trials 52

The Pharma Data

AUGUST 3, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. The study showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) 1%, compared with best supportive care (BSC). months for BSC.

HR 52

HR Antibody FDA Approval Licensing 52

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) is a HER2 directed antibody drug conjugate (ADC).

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

DECEMBER 3, 2020

Barnett will be responsible for all aspects of chemistry, manufacturing and controls (CMC), technical development, supply chain operations, and alliance management. Pfreundschuh will oversee the company’s financial strategy and activities related to accounting, investor relations, business development and business operations.

Development 52

Development Business Development Manufacturing Clinical Development 52

XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

SEPTEMBER 18, 2020

Chief Medical Officer and Head of Global Product Development. The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79;

Medicine 52

Medicine HR In-Vitro Protein 52

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.

HR 98

HR FDA Approval Gene Trials 98

The Pharma Data

AUGUST 3, 2021

Similar mortality benefit was observed by Day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1 The cumulative proportion of patients who died by Day 28 was 39.2 percent (n/N: 20/51) in the baricitinib arm versus 58 percent in the placebo arm (n/N: 29/50). percent (n/N: 23/51) for baricitinib compared to 62.0

HR 52

HR Licensing Licensing FDA Approval 52

XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

HR 52

HR Hormones FDA Approval Antibody 52

pharmaphorum

DECEMBER 9, 2022

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu is already making waves in breast cancer, and clinical results presented at the San Antonio Breast Cancer Symposium (SABCS) suggest they may see success with a second. The post SABCS: New ADC from AZ and Daiichi shows promise in breast cancer appeared first on.

HR 98

HR Antibody Hormones Drugs 98

Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development.

HR 52

HR Antibody In-Vitro DNA 52

The Pharma Data

APRIL 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). The median OS was 14.7 months (95% CI: 11.9,

Medicine 40

Medicine In-Vitro Antibody Branding 40

The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52