New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
Eisai and Biogen’s new Alzheimer’s treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimer’s disease.
In a groundbreaking development, a team of biochemical engineers from South Korea has unveiled a new exosome-based delivery system, termed MAPLEX, that holds the potential to transform treatments for various diseases, including Alzheimer’s.
Two months after placing a partial hold on a phase 1 clinical trial evaluating an antibody-drug conjugate (ADC) in cancer patients, the FDA is allowing the study to proceed with the lower doses of the treatment.
Driven by personal loss and inspired by the progress in disease management, Elaine has dedicated more than 20 years to the clinical trial technology industry.
With the FDA’s endorsement, Amgen and AstraZeneca are getting closer to adding chronic obstructive pulmonary disease (COPD) as a new indication to Tezspire.
Samsung Bioepis Co., Ltd. announced yesterday (July 23) that the US Food and Drug Administration (FDA) has approved Epsyqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).
Ionis Pharmaceuticals antisense therapy for Angelman syndrome achieved good early safety and efficacy results and the company now plans to advance the therapy to phase 3.
Results from a phase 1/2 clinical trial revealed that PolTREG’s regulatory T cell (Treg) therapy, PTG-007, was able to restore insulin secretion in children with type-1 diabetes.
Verona Pharma has revealed its ongoing preparations for the potential launch of ensifentrine in the US market, slated for the third quarter of 2024 pending FDA approval, expected by June 26, 2024.
Thousands of patients in England are set to be enrolled into groundbreaking trials for personalized cancer vaccines through an innovative NHS 'matchmaking' initiative aimed at saving lives.
EXO Biologics, a clinical-stage biotech specializing in exosome-based therapies, recently announced the successful raising of €16 million in Series A funding.
Clinical development analytics company Phesi has released a new analysis of global oncology trial investigator sites ahead of attending ASCO 2024 – the American Society of Clinical Oncology’s annual meeting.
Innovent Biologics has revealed encouraging phase 3 (DREAMS-2) findings for mazdutide, showcasing its superiority over dulaglutide in managing glycemic levels among patients with type 2 diabetes (T2D) in China.
AstraZeneca’s Fasenra (benralizumab) has recently been approved by the FDA for treating severe asthma in children aged 6 to 11 with the eosinophilic phenotype.
At the ASCT 2024 conference a few weeks ago, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighted a crucial issue in the future of clinical trials.
Endeavor BioMedicines, a clinical-stage biotech company, has announced promising phase 2a trial results for its lead investigational candidate, ENV-101.
Oxford BioDynamics (OBD) and King’s College London (KCL) have partnered to use OBD’s EpiSwitch technology to identify patients at risk of rheumatoid arthritis (RA) who can benefit from abatacept treatment.
Closed Loop Medicine, a techbio company specializing in personalized drug-plus-software therapies, and Pharmanovia, a global pharmaceutical firm known for rejuvenating established medicines, have initiated their OptiZest study.
The Asia-Pacific (APAC) region is leading the way in the asthma clinical trials space, conducting the most studies globally between 2019-2023, with China, India, and South Korea among the top countries, GlobalData reveals.
Calliditas Therapeutics has announced encouraging data from its proof-of-concept phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN).
Glucagon-like peptide-1 (GLP-1) receptor agonists, such as Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro, have garnered a lot of attention in the pharma industry and beyond.
Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) version of Entyvio, its treatment for adults with moderate to severe Crohn’s disease (CD).
Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome,...
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess...
The recent submission of clinical trial data for Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine to the U.S. FDA indicates the entry of new therapies for chronic obstructive pulmonary disease (COPD) in 2024.
Since Roche's Zelboraf (vemurafenib)gained FDA approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma.
Biopharma company Clene has published ‘impactful’ new research into CNM-Au8, its investigational drug in development for the treatment of neurodegenerative diseases.
Neurogene, a clinical-stage company developing genetic medicines, is expanding its ongoing phase 1/2 clinical trial investigating NGN-401 as a treatment for female pediatric patients with Rett Syndrome.
SolasCure is moving forward with its maggot-derived wound gel, after publishing the results of its recent phase 2 clinical trial in a leading wound care journal.
Allecra Therapeutics, a biopharma company developing novel therapies to combat antibiotic resistance, has received FDA approval for its treatment tackling ‘complicated’ urinary tract infections (UTIs).
Neuraxpharm Group, a European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, has announced the first launch of BRIUMVI (ublituximab) in Europe for the treatment of adult patients with relapsing multiple...
AN2 Therapeutics recently announced a decision to voluntarily pause enrollment of the phase 3 portion of the phase 2/3 trial, EBO-301, in light of potentially lower than expected efficacy data obtained from the phase 2 trial.
Biora Therapeutics recently announced the initiation of phase 1 clinical trials of BT-600, a novel drug-device combination for ulcerative colitis (UC) patients.
QBiotics’ lead intratumoural oncology asset, tigilanol tiglate, has been awarded Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) by the United States Food and Drug Administration (FDA).
Oncology company Oxford BioTherapeutics has announced that the first patient has been dosed in a phase 1b trial investigating its lead candidate OBT076, in patients with Adenoid Cystic Carcinoma (ACC) of the head and neck.
Ariceum Therapeutics, a biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, has submitted an application with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to...
Merck has announced a new licensing agreement with Inspirna for ompenaclid, a first-in-class treatment currently in phase 2 development for RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).
Biotech company SolasCure has announced the results of its proof-of-concept phase 2 trial investigating its wound gel for chronic venous leg ulcer patients.
Biosenic, a company specializing in serious autoimmune and inflammatory diseases and cell therapy, has secured funding from Singapore-based TrialCap, in a bid to accelerate its phase 3 clinical development.
