pharmaphorum

OCTOBER 14, 2021

The protein, Programmed Death-Ligand 1 (PD-L1), is found on the surface of many cells throughout the body. The approved treatment regime demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; 0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77];

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HR Containment Protein Clinical Development 45

Drug Discovery World

JUNE 1, 2023

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

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Antibody Marketing Drugs Licensing 98

The Pharma Data

SEPTEMBER 28, 2021

Data from the IMpower010 trial were published simultaneously within the Lancet. Data from the IMpower010 trial were published simultaneously within the Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88)

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Clinical Trials Clinical Trials Trials HR 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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Antibody Trials Production Clinical Trials 52

XTalks

MAY 2, 2024

Karuna’s FDA submission, made in September 2023, included data from one Phase II and two Phase III placebo-controlled trials. In the Phase III EMERGENT-3 trial, compared to placebo, KarXT led to a 9.6-point Karuna also has ongoing long-term extension trials. Results of the study are published in The Lancet.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

Drug Discovery World

JANUARY 9, 2024

The delayed release formulation of budesonide has shown greater efficacy for protein reduction and slowing the decline in kidney function in primary immunoglobulin A (IgA) as well as a much better safety profile than conventional corticosteroids. The therapy has shown positive results in Phase III trials in both breast and lung cancer.

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pharmaphorum

DECEMBER 1, 2021

The panel met shortly after updated results from the phase 3 MOVE-OUT trial of the drug showed it was less effective than previously thought, reducing the risk of hospitalisation or death in high-risk patients by around 30%. An earlier readout found a 48% reduction.

Drugs 52

Drugs HR Protein Development 52

pharmaphorum

JUNE 17, 2022

Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent. The active drug is nirmatrelvir, a protease inhibitor, which helps keep the SARS-CoV-2 protein from replicating.

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Drugs Clinical Trials Clinical Trials HR 105

The Pharma Data

SEPTEMBER 16, 2020

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. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme.

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HR Medicine Hormones Trials 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) Regular approval by the U.S. months [95% CI 9.6-14.3]

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

AUGUST 3, 2021

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) Results from the IMpower010 trial were presented at the 2021 ASCO Annual Meeting. 1%, compared with best supportive care (BSC).

HR 52

HR Antibody FDA Approval Licensing 52

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Microsomal triglyceride transfer protein inhibitor: lomitapide. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. 07.27.2022. 07.19.2022.

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The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.

HR 52

HR Trials In-Vitro Manufacturing 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

The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). For more information about ERLEADA ® , visit www.ERLEADA.com. *©

HR 52

HR Hormones Development Production 52

The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]);

Medicine 40

Medicine HR Trials Production 40

Drug Discovery World

APRIL 11, 2024

In clonogenic assay, BRCA2-deficient DLD1 cells were ~15-fold more sensitive to FEN1 inhibition than their isogenic BRCA2-wild-type counterparts (EC50 of 350nM and 5µM, respectively), confirming the increased susceptibility of HR deficient cancer cells to FEN1 inhibition. LAE119 is a potent and selective PARP1 inhibitor and PARP1-DNA trapper.

HR 52

HR Antibody In-Vitro DNA 52

XTalks

AUGUST 10, 2022

HER2-low is characterized by the presence of some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive. Prior to the approval of Enhertu, patients in the latter IHC/ISH category were not eligible for HER2-targeted therapies and mainly got endocrine therapy (if HR-positive disease) or chemotherapy.

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FDA Approval HR Hormones Antibody 98

XTalks

MARCH 22, 2021

Maverick’s COBRA platform is used to engineer protein-based therapies that target T cells in the tumor microenvironment to trigger their activation. The therapies are designed to induce T cell-mediated killing specifically at the tumor site while sparing healthy cells and tissue.

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Life Science Development Marketing Gene Expression 110

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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FDA Approval Drugs Sales Development 101

Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. No dosage adjustment is needed in patients with mild renal impairment.

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Marketing Production Drugs Licensing 75

The Pharma Data

APRIL 23, 2021

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). Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis. The median OS was 14.7 months (95% CI: 11.9,

Medicine 40

Medicine In-Vitro Antibody Branding 40

Drug Discovery World

APRIL 18, 2023

The results from the Phase I portion of the Phase I/II AcSé-ESMART trial were presented at the AACR Annual Meeting 2023. “To Impairments in homologous recombination (HR), a type of DNA repair, can sensitise cells to drugs called PARP inhibitors.

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DNA Genome Genomics HR 52

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

FDA Approval 52

FDA Approval Drugs Sales Development 52

Drug Discovery World

FEBRUARY 21, 2023

The FDA has granted expanded approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) for patients with HR-positive/HER2-negative metastatic breast cancer who have received hormonal therapy and at least two additional therapies in the metastatic setting.

HR 52

HR Hormones Sales Antibody 52

The Pharma Data

AUGUST 30, 2021

KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. months (95% CI, 7.6-11.3) months (95% CI, 5.3-7.5), months [95% CI, 5.4-32.4]

Hormones 52

Hormones HR Trials Protein 52

The Pharma Data

AUGUST 9, 2021

Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

Trials 52

Trials Medicine Development Clinical Trials 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Microsomal triglyceride transfer protein inhibitor: lomitapide. Immunosuppressants: voclosporin.

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Drugs Licensing Licensing Containment 69

The Pharma Data

SEPTEMBER 10, 2021

POSEIDON Phase III trial showed the addition of a short course of tremelimumab to Imfinzi plus chemotherapy improved patient outcomes without an increase in treatment discontinuation. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone (HR 0.72; 95% CI 0.60-0.86;

HR 52

HR Trials Immune Response Medicine 52

The Pharma Data

APRIL 26, 2022

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. 0.93; p=0.0035).4

Immune Response 52

Immune Response Trials Protein Antibody 52

Pfizer

DECEMBER 13, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Microsomal triglyceride transfer protein inhibitor: lomitapide. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

APRIL 7, 2021

months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. months from 1.7 0.54; p<0.0001).

HR 52

HR Genotype FDA Approval Genotoxicity 52

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

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Research Vaccination Vaccine Drugs 112

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

HR 52

HR FDA Approval Containment Genome 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. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 6.45 percent increase from the $9.13

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). chief medical officer and head of Global Product Development. “We

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Immune Response Medicine Protein Gene 52