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5+delta) protein vaccine (Sf9 cell). The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HRproteins of the XBB and BA.5 It is self-assembled into stable trimeric protein particles with the addition of squalene-based oil-in-water emulsion adjuvant following purification and mixing.
The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.
International biopharma executive Guillaume Herry has been appointed as CEO, while HR executive Joanne Reichardt has been appointed Head of People & Culture. The CDMO provides recombinant proteins, vaccines, and complex live biotherapeutic products to customers on the leading edge in emerging therapeutics.
The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy. It acts by hindering proteins in cancer cells to avert cell division and growth.
NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.
The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. Datroway leverages DXd technology to precisely target cancer cells.
Total, unprocessed, and processed red meat intake were each associated with a modestly higher risk for CHD (hazard ratio [HR] for one serving per day increment: 1.12 The intake of one serving per day of combined plant protein sources (nuts, legumes, and soy) was associated with a lower risk for CHD (HR, 0.86 Abstract/Full Text.
1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.
Cases with knee replacement (KR) or hip replacement (HR) between 2014 and 2018 were identified; each case was age- and gender-matched with up to four controls (913 cases and 3,652 controls, respectively). The relation of warfarin versus direct oral anticoagulant (DOAC) use with the risk for KR or HR was assessed.
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
Basel, June 23, 2021 — VISION data published today in The New England Journal of Medicine (NEJM) shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52?0.74]; months) and imaging-based progression-free survival (HR = 0.40 [99.2% 0.74]; P<0.001; median 15.3
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];
Previous studies have suggested that detection of viral proteins in body fluids could be a rapid diagnostic method for severe acute respiratory syndrome (SARS) ( 19 – 21 ). Nucleocapsid protein from SARS patients was abundant enough to be detected in clinical samples using an ELISA approach ( 20 ). RESULTS AND DISCUSSION.
KEYTRUDA in combination with chemotherapy (pac, nab-paclitaxel or gem/carbo) reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.49, 0.86]; p=0.0012), with a median PFS of 9.7 months (95% CI, 7.6-11.3) months (95% CI, 5.3-7.5), 7.5), versus the same chemotherapy regimens alone in these patients. months [95% CI, 5.4-32.4]
percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Accepted as ePoster – Adjuvant Systemic Therapy. Available on-demand on March 10, 2021. Selected for one of the three St.
months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; PD-L1 staining is the process by which the PD-L1 protein is visualised during testing. months (HR=0.76, 95% CI: 0.54–1.09). months compared with chemotherapy (median OS=20.2 0.89; p=0.0106) in people with high PD-L1 expression (TC3 or IC3-wild-type [WT]). About Tecentriq.
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.
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.
It was hailed as a potential game changer when the interim MOVE-OUT data emerged, but has since been eclipsed by a rival oral antiviral from Pfizer – Paxlovid – which achieved a much higher 89% reduction in hospitalisations or death in the phase 3 EPIC-HR trial.
VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. More Study Details Study Locations About the Study Breast cancer represents a significant challenge, and advancing treatment options is crucial for patients facing this disease.
Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. HR-positive breast cancer. GDC-0077 is our next generation investigational PI3K? Ipatasertib. Real world data.
months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; months (HR=0.76, 95% CI: 0.54–1.09). PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells. receptors.
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.
months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80]
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; 0.76; p<0.0001), compared with sorafenib.
Patients treated with a short course of five cycles of tremelimumab, an anti-CTLA4 antibody, over 16 weeks in addition to Imfinzi and chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; 0.92; p=0.00304). Median OS was 14.0 Tremelimumab.
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.
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).
The virus had originally been obtained from a person in Washington state with COVID-19, but as it was grown over time in the laboratory, it had acquired a mutation that led to a change of a single amino acid at position 484 in the virus’s spike protein. Systematic analysis of SARS-CoV-2 infection of an ACE2-negative human airway cell.
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) Data from the IMpower010 trial were published simultaneously within the Lancet. 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%,
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) 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%, 1%, compared with best supportive care (BSC). months for BSC.
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.
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. The PDUFA target action date for the breast cancer submission has been set for the first quarter of 2025.
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) months [95% CI 9.6-14.3] months [95% CI 6.9-10.7]
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.
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,
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.
Imaging techniques such as ultrasound and computerized tomography (CT) are used to visualize structural changes or abnormalities resulting from kidney damage or congenital causes, while urinalysis can be used to detect blood or protein in the urine — another indication of kidney damage. Developed in 1999 2. Expressed in mL/min/1.73m 2.
months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. 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).
months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]); with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; VENCLYXTO ® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. After a median follow-up of more than four years (52.4
0.514 mmol/24 hr/1.73 0.771 mmol/24 hr/1.73 Visit OXLUMO.com for more information, including full Prescribing Information. 1Normal is defined as urinary oxalate levels at or below the upper limit of normal (ULN; ? 2Near-normal is defined as urinary oxalate levels at or below 1.5 IMPORTANT SAFETY INFORMATION.
The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).
one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). The results passed the futility analysis (p<0.3 At day 5, the relative reduction compared to placebo was -1.1 log 10 copies/mL (nominal p=0.002 for combined doses).
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