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Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinicaltrials. Read the full report. Learn more about the NIH Collaboratory’s Distributed Research Network.
The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinicaltrials, dose-ranging is testing different drug doses against each other to establish which works best.
The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinicaltrial.
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.
AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca.
Results from a clinicaltrial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinicaltrial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)
The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinicaltrial sponsors to develop and deliver these emerging immunotherapies.
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.
Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinicaltrials or need to start planning to include.
In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5
SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders. SinoMab BioScience intends to commence a Phase I clinicaltrial in China to evaluate SM17’s safety profile.
The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods.
Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients. CLDN 18.2).
The World Health Organization (WHO) has made new recommendations for the usage of two monoclonal antibodies to treat the Ebola virus in its first published guideline. mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb) are the two monoclonal antibody treatments recommended by the WHO.
Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinicaltrial of LY-COV555, its neutralizing antibody therapy for COVID-19.
An experimental antibody treatment prevented malaria in the majority of participants in a small but important new study , providing a measure of hope in the effort to lower the burden of the disease worldwide. Read the rest…
Foralumab is a fully human anti-CD3 monoclonal antibody, which works by binding to the T-cell receptor and regulating T-cell function to reduce pulmonary inflammation. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinicaltrial upon successful feedback from the FDA.
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.
Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody. The therapy targets a unique epitope on CD20-expressing B-cells.
The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinicaltrial.
The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinicaltrial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4
Roche reported negative results Monday from a pair of clinicaltrials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease.
Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinicaltrials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?
The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .
In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinicaltrials.
The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. Tzield was evaluated in the placebo-controlled, double-blind, randomised, event-driven TN-10 clinicaltrial, for delaying T1D (Stage 3, or clinical T1D) in Stage 2 T1D patients.
According to the positive interim findings from the Phase II/III KidCOVE clinicaltrial, a two-dose primary series of mRNA-1273 offered a strong neutralising antibody response in the young children with a favourable safety profile.
seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%
Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). Clinicaltrials further demonstrated Jobevnes comparable performance in treating glioblastoma, renal cell carcinoma and advanced cervical and ovarian cancers.
Ameet Mallik takes over for founder Chris Martin at helm of the antibody drug developer after a seven-month run leading Rafael Holdings, which reported a clinicaltrial setback last October.
Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”
In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure.
Head and neck cancers are the seventh most common type of cancer worldwide, according to the 2020 World Cancer Report. Smokers and drinkers, as well as those with HPV infections, are disproportionately affected.
The latest MHRA decision is based on findings from the Phase II/III clinicaltrial, where the mRNA-1273.214 vaccine met all primary endpoints. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) 1) versus the 50µg mRNA-1273 booster dose.
The post Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab appeared first on Pharma Mirror Magazine. based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 (“RECIST 1.1”).
Otsuka Pharmaceutical has announced positive interim results from its Phase III clinicaltrial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.
NEW ORLEANS — An antibody treatment developed by the Belgian drugmaker Argenx raised platelet counts and stopped bleeding episodes in patients with a rare autoimmune disorder that causes the body to attack and destroy its own blood-clotting platelets.
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