about us

press release






FDA Updates

Clinical Trials

Medical Device News

Past News

Frontiers in Microbiology Publishes Article Detailing Novel Microbiome-based Biomarker of Post-Antibiotic Disruptions in Gut Microbiota

The Microbiome Health Index for post-Antibiotic dysbiosis (MHI-A), published in Frontiers in Microbiology, was developed to better understand and manage the risks of antibiotic administration and help guide the development of live biotherapeutic products – a potential new class of drugs.

Longeveron Announces Initiation of Phase 2a Clinical Trial of Lomecel-B for the Treatment of Alzheimer’s Disease

This Phase 2a study is intended to build on encouraging preliminary Phase 1 data that were announced in 2021.

Urovant Sciences Announces Publication in Advances in Therapy

“Our findings suggest that the statistically significant improvements in bothersome symptoms of OAB seen in the 12-week EMPOWUR trial are indeed clinically relevant in terms of patient perceptions,” said lead author Jeffrey Frankel, MD, of Seattle Urology Research Center.

Ultimate Medicine Publishes Data in Nature Aging Showing Novel Gut-Brain Pathway Metabolite Involved in Age-Related Cognitive Decline

“The discovery of delta-valerobetaine, a novel target that we are now leveraging for therapeutic applications as part of our UM 001 program, shows the power of our in vivo multiomics approach in discovering and validating targets and biological pathways,” said Dr. Antal Szalay, CEO and Founder of Ultimate Medicine.

MindMed Initiates Phase 2a LSD Trial for the Treatment of Adult ADHD

"We are pleased to activate our first site and excited to initiate patient enrollment of our ADHD proof-of-concept trial," said Robert Barrow, Chief Executive Officer and Director of MindMed.

Pivotal Phase III Study of P2B001 in Early Parkinson’s Disease Reported

The study successfully met its primary and key secondary endpoints, demonstrating superior efficacy of P2B001 compared to its individual components. P2B001 showed comparable efficacy to a marketed extended-release (ER) pramipexole with significantly less daytime sleepiness and a superior safety profile. Topline results support P2B001's potential as a first-line treatment for people with early Parkinson's disease, with easy administration (once daily with no titration). The company plans to file an NDA in 2022

Novartis Data Highlight Efficacy of Piqray® in HR+/HER2- Metastatic Breast Cancer with a PIK3CA Driver Mutation Immediately Post-CDK4/6i

"The data from all three cohorts of the BYLieve study have value for the medical community and for the patients we care for with mBC, because these cohorts show a benefit from alpelisib in the post-CDK4/6i setting for patients with HR+/HER2- PIK3CA-mutated cancer," said Dr. Hope S. Rugo, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Optibrium Shows Deep Learning to Successfully Predict Human Panel-based Sensory Perception of Novel Compounds Used for Flavours and Fragrances

Samar Mahmoud, Senior Scientist at Optibrium, said: “We have demonstrated Augmented Chemistry’s unprecedented capabilities to robustly predict otherwise intractable complex endpoints in several drug discovery collaborations with leading pharma and biotech companies. This study further underlines its translational capabilities, providing further evidence for its applicability to other related trial outcomes across fields such as drug discovery.”

Citius Pharmaceuticals Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK

Myron Holubiak, Chief Executive Officer of Citius said, "Completing enrollment in the Pivotal Phase 3 study of I/ONTAK moves us another step closer to expanding treatment options for patients suffering from advanced CTCL."

SOPHiA GENETICS Announces Launch of DEEP-Lung-IV Multimodal Clinical Study

SOPHiA GENETICS' DEEP-Lung-IV clinical study aims to predict immunotherapy treatment response at first evaluation at the individual patient level using data across multiple modalities including genomics, radiomics, clinical and biological data.

Updated Data from Lead Program CUE-101 for the Treatment of Recurrent/Metastatic HPV+ Head and Neck Cancer and Additional Pipeline Progress Reported

Monotherapy data further enhances confidence in CUE-101 potential as single agent therapeutic in the refractory/metastatic human papillomavirus positive head and neck squamous cell carcinoma (HPV+ HNSCC) setting

New Study Identifies Drivers of Scientific Research Productivity

“Our study shows a need for the scientific community to examine the best ways to measure the productivity of research,” Adrian Cooper, CEO at Oxford Economics, said. “This should support more efficient innovation development over the long term.”

Latest News

Accuredit Therapeutics and N1 Life Form a Joint Venture Named ‘Napoltec’, Dedicated to the Development of Therapeutic Drug Delivery Systems and Pressing Ahead Clinical...

"We are very pleased to establish a new joint venture, Napoltec, with N1 Life, which will be featuring complementary in mutually pursuing gene therapy drug development. The N1 Life team led by Dr. Zang and Prof. Wender has accumulated years of research and development experience in novel delivery systems.

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Release of the white paper concludes the efforts of the IWGACP. The FDA will consider the scientific opinions presented in the white paper, including having it peer-reviewed, as part of its overall efforts to help ensure the safety of talc-containing cosmetic products.

Hekka Labs Introduces the First Decentralized Chronic Disease Data Management Ecosystem in South Asia

Hekka has cemented initial partnerships with 3 Indian healthcare solution providers, Curisin, a healthcare company with a wide network of 30 million patients and 40,000 partnered doctors which as recently agreed to provide a minimum of 1.5 million medical records in 2022.

Impact NRS LLC Creates RumenEra Inc to Develop and Commercialize High-Impact Rumen Microbiome Applications in a Joint Collaboration with National Institute for Biotechnology in...

Mr. Salman continues "RumenEra is committed to the creation of a global reference standard for the rapid measurement of net feed efficiency, as well as creating products that can be applied to ruminants to optimize their efficiency while decreasing environmental burdens, naturally and healthily, for both the animals and their ecosystems."

Join Medical Device News Magazine's Mailing List: Receive a Weekly Recap of Device Industry News