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.
Dr. Michael O’Neal, chief medical officer at Clario, believes that many drugs ultimately fail due to common operational and data challenges that could, and should, be corrected.
We sat down with Cary Claiborne, CEO and president of Adial Pharma, to discuss the challenges of treating alcohol abuse and company's solution – a serotonin-3 receptor antagonist that could affect neurotransmitters like dopamine and modulate the...
Sanofi is planning to expand the market for its best-selling anti-inflammatory drug Dupixent, used to treat COPD, also known as ‘smokers lung’, after a successful second phase 3 trial.
The Pistoia Alliance is a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D. It has just announced its four new strategic priorities made up of global pharma and tech representatives to deliver new project...
Legend Biotech, a biotechnology company developing novel therapies to treat life-threatening diseases, has entered into an exclusive, global license agreement with Novartis Pharma.
IO Biotech, a clinical-stage biopharma company developing therapeutic cancer vaccines, has completed enrollment in its phase 3 trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma....
The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).
The antibody drug nipocalimab, developed by the Janssen Pharmaceutical...
Clerkenwell Health is partnering with Transcend Therapeutics to trial the use of methylone in patients with severe post-traumatic stress disorder (PTSD).
Arrowhead Pharmaceuticals has spotlighted the potential of RNA interference (RNAi) therapeutic candidates in the lungs, with a clinical late breaker and multiple pre-clinical presentations at this year’s European Respiratory Society (ERS) International...
Octave Bioscience, a precision care company advancing treatments for multiple sclerosis (MS), has announced the publication of the successful clinical validation of its multiple sclerosis disease activity (MSDA) test in the peer-reviewed journal Clinical...
Lytix Biopharma, a clinical stage immuno-oncology company, has completed recruitment of 20 patients in its trial evaluating LTX-315, the company’s lead drug candidate.
Novartis announced today (Monday August 28) that new long-term data from its open-label trial extension demonstrated twice-yearly dosing inclisiran with statin therapy provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six...
MEI Pharma has dosed the first patient in its phase 1 study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer.
Vaxxinity has announced the publication of its phase 2 clinical trial data for UB-311, stating that the treatment was safe, well-tolerated and demonstrated a trend for slowing cognitive decline in mild Alzheimer's disease (AD).
Epsilogen, a leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, has published phase 1 data from the first ever clinical trial of an IgE antibody therapeutic in Nature Communications.
IO Biotech, a clinical-stage biopharma company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, has dosed the first patient in its phase 1 bladder cancer trial.
Boston-based pharma company Ratio Therapeutics has initiated dosing in a phase 1 study evaluating the pharmacokinetics, biodistribution and radiation dosimetry of a novel fibroblast activation protein-alpha (FAP)-targeted radiopharmaceutical, RTX-1363S,...
Alnylam Pharmaceuticals has announced positive interim results for the ongoing single ascending dose portion of the phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment...
Nanjing Iaso Biotherapeutics and Innovent Biologics have received China National Medical Product Administration (NMPA) approval for Fucaso (equecabtagene autoleucel) as a treatment for patients with relapsed or refractory multiple myeloma who have received...
Lisa Moneymaker is full of energy, enthusiasm, and wisdom. She is well-known on the pharma circuit and it’s easy to see why. She has been chief technology officer and chief product officer at Saama since October last year and feels passionately about...
Sosei Heptares has dosed the first subject in a phase 1 trial evaluating HTL’149, a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.
Vial, a CRO providing clinical trial management services, has partnered with biopharma company Nielsen BioSciences to study the safety and efficacy of CANDIN, a treatment for common warts.
Vera Therapeutics, a late-stage biotech company focused on developing treatments for patients with serious immunological diseases, has announced the results of its phase 2 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN).
CStone Pharmaceuticals' shares have risen after academic journal Nature Cancer published the clinical study results of its lung-cancer treatment sugemalimab.
Axol Bioscience Ltd, a pluripotent stem cell technology provider for drug discovery, has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples.
