Explore

Online Platform Made-in-China Agrees to Halt Sales of Unapproved GLP-1 Drugs to U.S. Customers

Online Platform Made-in-China Agrees to Halt Sales of Unapproved GLP-1 Drugs to U.S. Customers

The international online platform Made-in-China has reached a settlement with the Connecticut Attorney General's office, agreeing to cease the sale of unapproved GLP-1 weight-loss medications to customers in the United States. The platform was found to be selling 'research grade' GLP-1 drugs without prescriptions or medical oversight, which are not approved for human use by the U.S. Food and Drug Administration (FDA). These drugs were often falsely marketed as generic versions of popular brand-name medications like Ozempic and Wegovy, but were found to contain impurities, potential bacterial contamination, and inconsistent active ingredient quantities, posing significant health risks. Made-in-China will implement a monitoring system to remove GLP-1 drug listings within five days and faces a $300,000 penalty, with $30,000 payable immediately and the remainder suspended pending compliance.

Roche's Enspryng Under Priority FDA Review for Rare Disease MOGAD

Roche's Enspryng Under Priority FDA Review for Rare Disease MOGAD

Roche's drug Enspryng (satralizumab) has entered priority review with the FDA for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare autoimmune disorder that causes unpredictable and severe attacks on the optic nerves, spinal cord, or brain. A decision from the U.S. regulator is anticipated by January 10 next year. Enspryng, an anti-IL-6 inhibitor, is already approved for anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The drug is also undergoing regulatory review for MOGAD in Europe, with decisions expected later in 2027. Roche reported global sales of approximately $470 million last year for Enspryng in the NMOSD indication. Approval for MOGAD would open a second rare disease market, with an estimated 17,000 patients in the U.S. and up to 300,000 worldwide.

Medication Management Essential for Effective Psychiatric Treatment and Patient Well-being

Medication Management Essential for Effective Psychiatric Treatment and Patient Well-being

Medication management is highlighted as an ongoing and crucial process for ensuring the safety and effectiveness of psychiatric treatment. It involves regular follow-up appointments, symptom monitoring, side-effect review, medication adjustments, and coordination with other aspects of a patient's care. Providers assess how medication impacts mood, sleep, energy, focus, and daily life, ensuring it aligns with the patient's diagnosis and overall health. Initial appointments are comprehensive, covering current symptoms, past diagnoses, previous medications, side effects, and treatment goals. Follow-up visits are essential because many psychiatric medications, such as antidepressants, take time to show full effects, and ongoing monitoring helps determine if adjustments are needed or if the medication remains beneficial. Patients are encouraged to actively communicate changes in symptoms or side effects to their providers.

Lexidrug Enhances Clinical Drug Information Platform with New FDA Approvals and Special Alerts Features

Lexidrug Enhances Clinical Drug Information Platform with New FDA Approvals and Special Alerts Features

Lexidrug, a comprehensive clinical drug information platform, has introduced new features and updated existing ones to improve access to high-quality information for healthcare professionals. Key enhancements include a dedicated section for "New FDA Drug Approvals," which lists recently approved drugs and provides direct links to their complete Lexi-Drugs monographs. Additionally, the platform now features "Special Alerts" to highlight critical medication information, such as black box warnings, safety issues, drug recalls, market withdrawals, and significant labeling changes. Lexidrug has also integrated "What’s New in Drug Therapy" summaries, curated by expert authors and editors, directly from its landing page, offering brief updates on clinically important topics with links to original research. The platform continues to offer patient education handouts in up to 20 languages, designed to help patients understand their treatment plans and manage their health.

Senphonix Receives National Science Foundation Grant to Advance Continuous Vitals Monitoring Platform

Senphonix Receives National Science Foundation Grant to Advance Continuous Vitals Monitoring Platform

Senphonix, Inc., a medical-technology startup, has been awarded a Small Business Technology Transfer (STTR) Phase I grant from the U.S. National Science Foundation (NSF) through America's Seed Fund. This funding will support the engineering development of SleeveSense, a wearable device designed for continuous, long-term monitoring of patients' vital signs. The award specifically targets strengthening the device's wireless and radio-frequency systems and advancing it from a prototype to a manufacturable product at scale. Senphonix is collaborating with the University of Arizona on this project, focusing on performance in real hospital environments, including antenna and power systems. The company aims to pursue U.S. Food and Drug Administration (FDA) clearance for SleeveSense in early to mid-2027, following clinical testing expected to begin in late 2026 or early 2027. This grant builds on previous support from the State of Arizona, including matching funds from the Arizona Commerce Authority.

Short Workouts Boost Brain Function After Sleep Deprivation, Study Finds

Short Workouts Boost Brain Function After Sleep Deprivation, Study Finds

Short Workouts Boost Brain Function After Sleep Deprivation, Study Finds

Florida Times-Union

Nemours hearing therapy, UF Health mobile unit, new St. V's president

Nemours hearing therapy, UF Health mobile unit, new St. V's president

Nemours gets "remarkable" results in hearing therapy, while UF Health unveils a mobile unit and Ascension St. Vincent's Riverside names new president.

Compass Pathways Reports Positive 52-Week Data for COMP360 Psilocybin in Treatment-Resistant Depression

Compass Pathways Reports Positive 52-Week Data for COMP360 Psilocybin in Treatment-Resistant Depression

Compass Pathways, a biotechnology company, has released positive 52-week topline results from Part C of its Phase 3 COMP005 trial for COMP360 psilocybin, an investigational treatment for treatment-resistant depression (TRD). The data indicates that an additional dose of COMP360 25 mg provided further benefit, leading to an average 13-point reduction from baseline in MADRS scores at Week 52, with durability extending out to one year for participants who received an additional dose. For participants who initially received a placebo and then their first dose of COMP360 25 mg in Part C, the findings reinforced that a single dose can produce rapid onset, meaningful effect, and durability. Across all participants who received a 25 mg dose in Part C, response rates of 40%-45% and remission rates of approximately 30% were observed within six weeks. The safety profile of COMP360 in Part C remained consistent with previous parts of the trial, showing a generally well-tolerated and safe profile without new safety fin...

Autolus Therapeutics Receives FDA RMAT Designation for Obe-cel in Lupus Treatment

Autolus Therapeutics Receives FDA RMAT Designation for Obe-cel in Lupus Treatment

Autolus Therapeutics plc, a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to obecabtagene autoleucel (obe-cel). This designation is specifically for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN). The RMAT designation is a program established under the 21st Century Cures Act, designed to expedite the development and regulatory review process for regenerative medicine therapies, including cell therapies, that are intended to treat serious or life-threatening diseases. Autolus Therapeutics is currently enrolling patients in LUMINA, a pivotal Phase 2 study for obe-cel in refractory lupus nephritis, and expects to report data in 2028. The company also submitted a data update from the Phase 1 CARLYSLE trial for presentation at the American College of Rheumatology (ACR) Annual Meeting in the fourth quarter of 2026.

Editas Medicine Prepares for First Human Trial of CRISPR Cholesterol Therapy EDIT-401

Editas Medicine Prepares for First Human Trial of CRISPR Cholesterol Therapy EDIT-401

Editas Medicine is advancing towards a first-in-human study for EDIT-401, an in vivo CRISPR-edited medicine designed to reduce LDL cholesterol in patients with heterozygous familial hypercholesterolemia. According to CEO Gilmore O’Neill, the company is focused on in vivo CRISPR-edited medicines that offer differentiated efficacy and utilize gene-editing capabilities. EDIT-401 aims to increase the production of LDL receptors in liver cells, thereby enhancing the removal of LDL cholesterol from the bloodstream. Preclinical findings in non-human primates showed a mean reduction of 90% in LDL cholesterol, lipoprotein(a), and apolipoprotein B. The treatment is designed as a single intravenous infusion. Editas Medicine has submitted documentation to human research ethics committees in Australia and plans to dose the first patients this year. The Phase 1 trial will involve serial dose-escalation cohorts and an expansion into a broader patient population. The company anticipates sharing safety data in the first qu...

Xeris Biopharma Details Comprehensive Development Program for XP-8121, a Once-Weekly Hypothyroidism Treatment

Xeris Biopharma Details Comprehensive Development Program for XP-8121, a Once-Weekly Hypothyroidism Treatment

Xeris Biopharma Details Comprehensive Development Program for XP-8121, a Once-Weekly Hypothyroidism Treatment

ARPA-H Initiates Program to Develop FDA-Authorized Clinical AI for Cardiovascular Care

ARPA-H Initiates Program to Develop FDA-Authorized Clinical AI for Cardiovascular Care

The Advanced Research Projects Agency for Health (ARPA-H) has launched the Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program, committing up to $33.7 million in its first year. This four-year program, with a total budget of $62.7 million, aims to create the world's first reliable, FDA-authorized clinical agentic AI system for 24/7 cardiovascular care. The goal is to establish a digital member of the clinical care team that can autonomously support heart failure patients between visits and escalate to human care teams when necessary. Selected teams, including Atman Health, Tempus AI, and Updoc, will develop patient-facing clinical AI agents. Stanford University will develop a supervisory AI agent to monitor these clinical agents for safety and out-of-distribution behavior. Duke University and Kaiser Permanente will focus on scalable implementation strategies within health systems, particularly in rural and underserved communities. The program will engage the U.S. Food and Drug Administ...