MedPath

Tagged News

Regener-Eyes Receives FDA Closure of Voluntary Recall, Returns to Full Operations with Enhanced Safety Features

FDA Approval
  • The U.S. Food and Drug Administration has officially closed Regener-Eyes' voluntary product recall, marking full regulatory resolution and return to normal operations for the dry eye treatment company.
  • The company proactively initiated the recall out of abundance of caution and introduced an enhanced bottle design featuring advanced backflow prevention technology to protect against microbial contamination.
  • Regener-Eyes is now in full production and distribution of its upgraded bottle design while maintaining confidence in the product's continued safety and efficacy for treating dry eyes.

FDA Clears RMIT-Developed Ingestible Gas Capsule for Diagnosing Gut Motility Disorders

FDA Approval
  • The Atmo Gas Capsule, originally invented at RMIT University, has received FDA 510(k) clearance for diagnosing gastrointestinal motility disorders including gastroparesis and slow transit constipation.
  • The regulatory approval was based on a pivotal clinical study involving more than 200 subjects across 12 trial sites in the US and Australia, demonstrating the device's safety and efficacy.
  • The ingestible capsule measures gases as it travels through the digestive system and wirelessly transmits data to provide clinicians with comprehensive diagnostic information.
  • Atmo Biosciences licensed the technology from RMIT in 2018 and will launch the market-ready device in July 2025, addressing an unmet clinical need affecting millions worldwide.

Amgen Escalates Patent Defense with Three New Biosimilar Lawsuits Targeting Denosumab Competitors

Monoclonal AntibodyFDA Approval
  • Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.
  • The lawsuits allege infringement of 26-34 patents each and claim the defendants failed to comply with BPCIA "patent dance" requirements by withholding key manufacturing information.
  • These cases represent the sixth, seventh, and eighth denosumab biosimilar litigations by Amgen, following previous suits against Sandoz, Celltrion, Samsung Bioepis, Fresenius, and Accord Biopharma.
  • The targeted biosimilars include RGB-14-P/RGB-14-X (Hikma/Richter), HLX14 (Shanghai Henlius/Organon), and an unnamed Biocon product, all seeking to compete with Amgen's Prolia and Xgeva brands.

JB Chemicals Secures FDA Approval for Generic Amitriptyline Depression Treatment

Drug ApprovalFDA Approval
  • JB Chemicals and Pharmaceuticals Ltd received final FDA approval for its generic Amitriptyline Hydrochloride tablets in six dosage strengths for treating depression symptoms.
  • The approval allows the Indian pharmaceutical company to market its generic version of the tricyclic antidepressant in the US market, strengthening its regulated market presence.
  • This development supports JB Chemicals' international expansion strategy, with the company reporting 15.5% year-on-year net profit growth to ₹145.7 crore in the March quarter.
  • Analyst sentiment remains positive with 14 out of 15 analysts maintaining 'buy' ratings and price targets suggesting 11.4% potential upside.

TISSIUM Receives FDA De Novo Authorization for First Atraumatic Sutureless Peripheral Nerve Repair System

FDA Approval
  • TISSIUM's COAPTIUM® CONNECT with TISSIUM Light has received FDA De Novo marketing authorization, becoming the first and only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
  • The system addresses limitations of traditional microsurgical sutures by offering a reproducible, atraumatic alternative that preserves nerve integrity and simplifies the coaptation process for peripheral nerve injuries.
  • In a clinical study of 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success with all patients regaining full digit function and reporting no pain at 12 months.
  • This regulatory milestone marks TISSIUM's entry into the U.S. market and validates the company's biopolymer platform for tissue reconstruction applications.

BMJ Investigation Uncovers Data Integrity Issues in AstraZeneca's Ticagrelor Heart Drug Trials

FDA Approval
  • A BMJ investigation has revealed evidence of serious misreporting in two clinical trials that were pivotal to ticagrelor's approval by the FDA and UK regulators.
  • The investigation found that primary endpoint results were inaccurately reported in the journal Circulation, and more than 60 of 282 platelet machine readings were missing from FDA datasets.
  • Experts warn that millions of patients taking the anti-clotting drug may be receiving a treatment that is less effective than originally claimed, with some studies suggesting it may increase risks.
  • The drug, prescribed around 45,000 times per month on the NHS, was approved in 2011 after trials appeared to show it could prevent one in five deaths after a heart attack.

Cube Click Secures FDA Approval for SMILE Dx AI-Powered Dental Diagnostic Platform

AIFDA Approval
  • Cube Click's SMILE Dx has received FDA approval as the first AI-powered diagnostic platform capable of identifying cavities, root canals, and periodontal disease at the radiographic pixel level.
  • The device addresses a significant clinical need, as the FDA reports dentists routinely misdiagnose over 20% of cavities and root canal pathologies.
  • Clinical studies demonstrate SMILE Dx delivers an average 19% improvement in diagnostic detection accuracy compared to traditional methods.
  • The company projects potential annual revenue of $62 million by capturing just 2% of the $3.1 billion dental AI imaging market, which is growing at 22.3% CAGR.

Insulet Presents Real-World Evidence of Omnipod 5 Benefits in Type 2 Diabetes at ADA 2025

Real World EvidenceFDA Approval
  • Insulet shared real-world glycemic outcomes data from over 23,000 people with type 2 diabetes using the Omnipod 5 automated insulin delivery system in the United States.
  • New analysis from the SECURE-T2D pivotal trial demonstrated that Omnipod 5 significantly reduced diabetes distress in adults with type 2 diabetes over 13 weeks.
  • More than 30% of new patient starts in Q1 2025 were people with type 2 diabetes, reflecting growing adoption since FDA expanded indication in August 2024.
  • The company is advancing development of next-generation hybrid closed-loop and fully closed-loop systems, with plans to begin second EVOLUTION studies for type 2 diabetes in the second half of 2025.

Kaiser Permanente Launches FDA-Approved Gene Therapy Program for Pediatric Sickle Cell Disease

FDA ApprovalRare Disease
  • Kaiser Permanente Southern California will launch an FDA-approved gene therapy program for pediatric sickle cell disease patients through a partnership with Downey Medical Center and City of Hope.
  • The program will serve approximately 220 children aged 12 and above currently treated by Kaiser Permanente, with the first patient scheduled for treatment this summer.
  • The gene therapy process involves extracting stem cells from the patient's blood, modifying them in a laboratory, and reinfusing them to provide a cure without requiring donor matching.
  • This treatment addresses a critical unmet need, as sickle cell disease affects approximately 100,000 Americans and reduces life expectancy by more than 20 years compared to the national average.

Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)

NCT03263559CompletedPhase 2
Medical College of Wisconsin
Posted 10/3/2017

Bavarian Nordic Sells Priority Review Voucher for $160 Million Following Chikungunya Vaccine Approval

Drug ApprovalFDA Approval
  • Bavarian Nordic announced the sale of its Priority Review Voucher for $160 million, awarded following FDA approval of its chikungunya vaccine VIMKUNYA in February 2025.
  • The transaction is expected to close in Q3 2025 and will positively impact the company's EBITDA, with the National Institutes of Health receiving 20% of proceeds under a licensing agreement.
  • The sale reflects an uptick in PRV values in 2025, with recent transactions ranging from $150-160 million compared to the historical average of around $100 million.
  • Priority Review Vouchers reduce FDA drug review times from ten months to six months and are awarded for treatments addressing neglected tropical diseases, rare pediatric conditions, or material threat medical countermeasures.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.