article thumbnail

FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

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 clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

article thumbnail

Building a global supply chain network for clinical trial products

Pharmaceutical Technology

Clinical trial design continues to increase in complexity, and temperature-controlled logistics – in particular cold chain and frozen and associated supply chains – must also advance to keep pace with technological developments. Temperature-controlled clinical trial supply chain.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

Pharma Phorum

Antibody flunks post-exposure prevention study. The results of the STORM CHASER trial found there were 23 cases of COVID-19 among 273 people treated with a single dose of AZD7442 given as an intramuscular injection, compared to 17 out of 372 subjects in the placebo group.

Antibody 119
article thumbnail

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials.

article thumbnail

Monoclonal Antibody Lecanemab Finalizing Clinical Trials for Alzheimer’s Disease Treatment

XTalks

Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A?

article thumbnail

Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

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% FCM data are used to make clinical decisions around safety, efficacy, and pharmacodynamics.

article thumbnail

New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

BioPharma Reporter

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.

article thumbnail

Covid vaccine booster raises antibody levels in fight against Omicron

Pharma Phorum

Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5 News R&D clinical trials coronavirus COVID-19 Omicron pharma vaccine

Antibody 115
article thumbnail

HPV and the New Velocity Clinical Research HPV Vaccine Clinical Trial

Riverside Clinical Research

Velocity Clinical Research. The mission, at Velocity Clinical Research, is to help make the world a better place with a future filled with hope and extraordinary medical possibilities. Clinical study volunteers are also able to take a more active part in their own healthcare.

article thumbnail

Artificial Intelligence for better antibody drugs: ready for prime time?

Pharma Phorum

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline. Natural Antibody.

Antibody 123
article thumbnail

US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

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).

article thumbnail

FDA Accepts BLA For Byondis’ Antibody-Drug Conjugate [Vic-]Trastuzumab Duocarmazine

XTalks

The BLA, which grants permission to distribute a biological therapy across states in the US, was accepted based on data from the company’s Phase III trial. Later lines of treatment can include monoclonal antibodies, tyrosine kinase inhibitors and antibody-drug conjugates (ADCs).

article thumbnail

GSK, Vir build case for COVID-19 antibody drug with new study data

Bio Pharma Dive

Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19

Antibody 297
article thumbnail

Sanofi and GSK begin clinical trials of coronavirus vaccine

Pharma Phorum

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. They said the trials would involve 440 adults at 11 sites across the US.

article thumbnail

Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Bio Pharma Dive

Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19

Nurses 283
article thumbnail

Receptor Occupancy Assays by Flow Cytometry: Benefits for Clinical Trials

XTalks

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic.

article thumbnail

AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

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.

Antibody 264
article thumbnail

Regeneron’s Antibody Drug Becomes First Approved Treatment for Ebola

XTalks

Inmazeb is a combination of three different antiviral monoclonal antibodies. However, that outbreak was controlled before Regeneron’s drug could be tested in a clinical trial. The PALM Trial.

article thumbnail

Global Lung Cancer Antibodies Market, Drug Sales & Clinical Trials Insight Report to 2028 – ResearchAndMarkets.com

BioTech 365

Global Lung Cancer Antibodies Market, Drug Sales & Clinical Trials Insight Report to 2028 – ResearchAndMarkets.com Global Lung Cancer Antibodies Market, Drug Sales & Clinical Trials Insight Report to 2028 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Global Lung Cancer Antibodies Market, Drug … Continue reading → Business Wire

Sales 40
article thumbnail

Researchers Are Hatching a Low-Cost Coronavirus Vaccine

NY Times

A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.

Research 115
article thumbnail

Xilio Therapeutics Announces Clinical Trial Collaboration With Merck on Anti-CTLA-4 Monoclonal Antibody Program

BioTech 365

article thumbnail

First patients in NIH ACTIV-3 clinical trial enroll in Dallas

Scienmag

Infectious Emerging Diseases Clinical Trials Health Care Immunology/Allergies/Asthma Infectious/Emerging Diseases Medicine/Health Researchers/Scientists/Awards

article thumbnail

Tychan to Start COVID-19 Phase 3 Clinical Trial For Novel Monoclonal Antibody TY027

BioTech 365

Tychan to Start COVID-19 Phase 3 Clinical Trial For Novel Monoclonal Antibody TY027 Tychan to Start COVID-19 Phase 3 Clinical Trial For Novel Monoclonal Antibody TY027 Phase 1 Clinical Trials Demonstrate Safety of this Novel Monoclonal Antibody SINGAPORE–(BUSINESS WIRE)–In June … Continue reading → Business Wire

article thumbnail

Global TROP2 Antibody Market & Clinical Trials Insight Research Report 2021-2026 – ResearchAndMarkets.com

BioTech 365

Global TROP2 Antibody Market & Clinical Trials Insight Research Report 2021-2026 – ResearchAndMarkets.com Global TROP2 Antibody Market & Clinical Trials Insight Research Report 2021-2026 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Global TROP2 Antibody Market & Clinical Trials Insight 2026” report has been … Continue reading → Business Wire

article thumbnail

Researchers Are Hatching a Low-Cost Covid-19 Vaccine

NY Times

A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.

Research 105
article thumbnail

Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6026, a Monoclonal Antibody Targeting OX40

BioTech 365

Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6026, a Monoclonal Antibody Targeting OX40 Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6026, a Monoclonal Antibody Targeting OX40 GUANGZHOU, China–(BUSINESS WIRE)–#ADCC–Bio-Thera Solutions, Ltd. (SH:

article thumbnail

Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19

Scienmag

Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.

article thumbnail

NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins

Scienmag

Credit: NIAID A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun.

article thumbnail

Ology Bioservices Enters Phase 1 Clinical Trial for Anti-COVID-19 Monoclonal Antibodies

BioTech 365

Ology Bioservices Enters Phase 1 Clinical Trial for Anti-COVID-19 Monoclonal Antibodies Ology Bioservices Enters Phase 1 Clinical Trial for Anti-COVID-19 Monoclonal Antibodies ALACHUA, Fla.–(BUSINESS

article thumbnail

#news #biotech EU COVID-19 antibody ready for clinical trials

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: EU COVID-19 antibody ready for clinical trials. from European Biotechnology – first and foremost in European biotech [link].

article thumbnail

Eli Lilly’s Dual Antibody Bamlanivimab and Etesevimab Treatment Lowers Risk of COVID-19 Hospitalizations and Deaths

XTalks

Data from Eli Lilly and Company’s (NYSE: LLY) Phase III clinical trial evaluating its monoclonal antibody drugs bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) show that combining the two significantly reduced the risk of COVID-19 hospitalizations and death by 70 percent.

article thumbnail

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

Rugo, MD, professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, US and principal investigator of the TROPiCS-02 study, in the press release.

HR 52
article thumbnail

Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid

NY Times

Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials Antibodies Food and Drug Administration Merck & Company Inc Pfizer IncPfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.

article thumbnail

AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

XTalks

This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Knopman, MD, a clinical neurologist at the Mayo Clinic.

article thumbnail

UCB and Cancer Research UK partner for oncology antibody candidates

Pharmaceutical Technology

Global biopharmaceutical firm UCB and Cancer Research UK have entered a multi-project partnership to advance two of the former’s oncology antibody candidates through clinical trials.

Antibody 130
article thumbnail

Mix-and-Match Covid Boosters: Why They Just Might Work

NY Times

Clinical Trials Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Antibodies Immune System Johnson & Johnson Moderna Inc Pfizer Inc Food and Drug AdministrationThe F.D.A.

article thumbnail

Global Trispecific Antibodies Market to 2024 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.com

BioTech 365

Global Trispecific Antibodies Market to 2024 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.com Global Trispecific Antibodies Market to 2024 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Global Trispecific Antibodies Market Opportunity & Clinical Trials Insight 2024” … Continue reading → Business Wire

article thumbnail

Eli Lilly’s Bamlanivimab-Etesevimab Antibody Duo Cuts COVID-19 Hospitalizations and Deaths by 87 Percent

XTalks

Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The antibody was developed in conjunction with Vancouver-based AbCellera.

article thumbnail

Roctavian, the First Hemophilia A Gene Therapy, Attains EC Approval

XTalks

The CMA is for adult patients who do not have a history of factor VIII inhibitors and who do not have detectable antibodies to adeno-associated virus serotype 5 (AAV5). XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research.

article thumbnail

Briumvi is FDA Approved for Relapsing Forms of Multiple Sclerosis

XTalks

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS).

article thumbnail

Sanofi/Translate start clinical trial of mRNA COVID shot

Pharma Phorum

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart.

article thumbnail

Vaccine for the Prevention of Cytomegalovirus (CMV)

Riverside Clinical Research

Pregnant women who have already developed CMV antibodies will most likely not transmit the virus to their unborn fetus, but pregnant mothers with new CMV cases may. Velocity Clinical Research conducts clinical research in an effort to safely protect people against infections.

article thumbnail

COVID-19 Prevention Network launches two research studies evaluating monoclonal antibodies

Scienmag

– The COVID-19 Prevention Network (CoVPN) today announced two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. Biology Clinical Trials Infectious/Emerging Diseases Medicine/Health Public Health Virology