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It’s time for my mid-week regulatory and clinic updates. Here are the top headlines I found this week across Medical Devices and Biotech. 🔔The FDA has given a green light to an at-home test that checks for both COVID-19 and the flu—a first for the agency, outside of the additional authorities that it received during the coronavirus pandemic. Previous over-the-counter combination tests had been granted Emergency Use Authorizations. The Rapid Check test from Healgen received a de novo clearance through the FDA’s traditional product review pathways. 🔔Medtronic has been notifying users of its MiniMed insulin pumps to be aware of potentially shortened battery lives and to heed the devices’ low-power warnings and alerts. Now, the FDA has elevated the efforts into a Class I recall, the agency’s most serious category, following reports of dangerously high blood sugar levels. 🔔Ten years after first collecting an FDA approval, it’s time for version number two. Exact Sciences has received an agency green light for Cologuard Plus, the next generation of its mainstay, at-home screening test for colorectal cancer. 🔔Siemens Healthineers has received a new go-ahead from the FDA for what the company describes as its first completely redesigned mammography platform in over a decade. 🔔Sage Therapeutics has seen another clinical trial go up in smoke. The biotech called time on its plans to develop dalzanemdor in Alzheimer’s disease after seeing midphase data, adding to an earlier Parkinson’s flop and leaving the team looking to an upcoming readout in Huntington’s to rescue the prospect. 🔔The sun has set on Johnson & Johnson’s SunRISe-2 study. J&J called a halt to the phase 3 bladder cancer trial after an interim look at the data showed the TAR-200 candidate was no better than chemoradiation. 🔔A phase 3 trial of Scholar Rock’s spinal muscular atrophy (SMA) candidate has hit its primary endpoint, sparking a 200%-plus premarket surge in the biotech’s stock price. Investors went wild despite the higher dose falling short of the targeted efficacy and Scholar Rock making no mention of a key secondary goal.  #medicaldevices #biotech #drugdiscovery #fda

📣 FDA Issues Draft Guidance on Tissue Biopsies in Clinical Trials BioChain is committed to advancing translational research and precision medicine by providing high-quality biospecimens and solutions that meet the latest regulatory and scientific standards. The FDA’s recently issued draft guidance on tissue biopsies in clinical trials marks a pivotal step toward greater consistency, quality, and patient safety in clinical research. Key Highlights of the Draft Guidance: 1. Detailed recommendations for the collection, handling, and analysis of tissue biopsies in the clinical trial setting. 2. Emphasis on minimizing variability in biopsy procedures across studies to ensure reproducibility and reliability of results. 3. Enhanced focus on safeguarding patient safety and ensuring ethical considerations in biopsy collection. Join the Discussion: We invite our colleagues to share their insights on the implications of this guidance for their research workflows. How might these recommendations shape the future of tissue-based clinical research? At BioChain, we are proud to support the scientific community by delivering solutions that adhere to the highest standards of quality and reliability, enabling breakthroughs in biomarker discovery and therapeutic innovation. Read the press release here: https://bit.ly/3WjnkvL #FDA #ClinicalTrials #TissueBiopsies #PrecisionMedicine #RegulatoryGuidance #BioChain

If you’ve worked with human clinical samples, you know the challenge inconsistent specimen collection and handling processes pose to rigor and reproducibility when paired with cutting edge assays (all assays really). If implemented effectively, this is good news.

#ICYMI our EVP, Chief Medical Officer Jorge A. Quiroz MD, MBA, was recently interviewed by NeurologyLive to discuss our Phase 2 study assessing NMD670, a neuromuscular transmission enhancer, for patients with spinal muscular atrophy (#SMA). The Phase 2 clinical trial (NCT05794139) is a randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the efficacy, safety, and tolerability of twice-a-day oral dosing of NMD670 for 21 days in ambulatory adult patients with SMA Type 3. The study is an international multicenter study including sites in North America and Europe. Watch the full interview here: https://lnkd.in/e_kjgcHN #NMDPharma #Biotech #Innovation #NeuromuscularDisease #SMA #SpinalMuscularAtrophy #ClinicalResearch

Good afternoon, folks. It’s time for my mid-week regulatory and clinic updates. Here are the top headlines I found this week across Medical Devices and Biotech. ➡️ GE HealthCare has secured the FDA’s approval for an injectable, radioactive imaging agent that gives clinicians a clearer picture into blocked arteries in the heart and any damage to cardiac tissue. ➡️ The FDA has granted a de novo clearance to Pi-Cardia’s ShortCut device, designed to open up previously implanted heart valves and clear a path for blood to flow into the coronary arteries, allowing patients to undergo a successive transcatheter aortic valve replacement procedure. ➡️ Synchron’s brain-computer interface tech meets safety goal. Synchron also reported evidence the device worked in the six-patient trial, with the conversion of brain signals to motor outputs allowing people to perform digital tasks. ➡️ Cereno Scientific’s hypertension drug was shown to improve the risk score of 43% of patients in a phase 2 study. Of the 21 participants with pulmonary arterial hypertension (PAH), nine demonstrated an improved risk score—a measurement of the risk of death from the condition—after 12 weeks of treatment with Cereno’s histone deacetylase (HDAC) inhibitor, dubbed CS1. ➡️ On the same day that some Parkinson’s disease drugs are being called into question, AbbVie has announced that its late-stage monotherapy candidate has significantly reduced the burden of the disease in patients compared to placebo ➡️ IntraBio Wins FDA Nod for Ultra-Rare Neurodegenerative Disease on Heels of Competitor’s Approval. IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa. ➡️ Surmodics announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this range. #medicaldevices #healthcare #biotech #drugdiscovery #fda #clinicalnews

Insilico Medicine announced positive topline results from the Phase 2a trial of ISM001-055, the novel drug candidate developed in-house using generative AI to target TNIK (Traf2- and NCK- interacting kinase) for the treatment of idiopathic pulmonary fibrosis (IPF). The results demonstrate that ISM001-055 is safe, well-tolerated, exhibits a favorable pharmacokinetics (PK) profile, and has encouraging clinical efficacy as measured by improvement in forced vital capacity (FVC) at 12 weeks. "I am very impressed by the positive results observed in IPF patients treated with ISM001-055, particularly the encouraging improvement in FVC. It not only reflects ISM001-055's potential to slow disease progression but also suggests its capability to stop or even reverse it," said Zuojun Xu, M.D., Professor of Peking Union Medical College and the principal investigator in the Phase 2a trial of ISM001-055 in IPF patients. #IPFTreatment #ClinicalTrials #PharmaInnovation #BiotechBreakthrough #PulmonaryFibrosis #AIinDrugDiscovery #DrugDevelopment #Pharmacokinetics #TNIKInhibitor #MedicalResearch #HealthTech #LifeSciences #PositiveResults #TransformingHealthcare #QimingPortfolio #QimingHealthcare Read More: https://lnkd.in/gZzC4a-D

Clinical Trials Drive Medical Advances! Read more about why you should consider participating in a clinical trial near you. #ClinicalResearch #GlobalCRO #CRO #ClinicalTrials #Biotech #ClinicalProjectManagement #GlobalContractResearchOrganization #PatientRecruitmentServices #PharmaceuticalResearch #ContractResearchOrganization #ClinicalTrialManagement #DrugDevelopment #DecentralizedClinicalTrials #APAC #MiddleEast #Africa #Oncology #Thoracic #HepatocellularCarcinoma #MedTech #PopulationScience #HealthEquity #ThoracicClinicalTrials #HealthLiteracy #InclusiveClinicalResearch #GlobalCommunity https://lnkd.in/gWqjpsiQ

💔 Neuro-Oncology Patients Face Financial Strain from Vorasidenib Treatment 💔 The introduction of vorasidenib, a groundbreaking IDH inhibitor for gliomas, brings hope but also significant financial challenges. With an annual cost exceeding $150,000, many patients are grappling with the harsh realities of medical debt and income loss. 🌍 Global Disparities in Drug Pricing While the U.S. follows a market-driven pricing model, countries like the UK and Germany utilize negotiated pricing strategies to enhance patient access and manage costs. This stark contrast highlights critical disparities in healthcare economics. 📉 Impact on Patient Outcomes The financial burden can lead to lower treatment adherence and even abandonment, ultimately affecting patient quality of life and outcomes. To ensure equitable access to this promising treatment: - We must refine drug approval processes. - Implement robust patient assistance programs. - Balance innovation with affordability. As we navigate this evolving landscape in neuro-oncology, let’s prioritize both clinical efficacy AND economic sustainability for all patients! 👉 Click the link for more insights! #DrugPricing #HealthEconomics #HealthcareAccess #NeuroOncology #PatientCare #Pharma #PricingandReimbursement #Publications #RegulatoryAgencies #Vorasidenib #MarketAccess #MarketAccessToday

🚀 Exciting News! 🚀 We are thrilled to announce the publication of our latest research article titled "Efficient Nebulization and Pulmonary Biodistribution of Polymeric Nanocarriers in an Acute Lung Injury Preclinical Model" in Small Science in collaboration with INSTITUT DE CIÈNCIA DE MATERIALS DE BARCELONA (ICMAB-CSIC) and Aerogen. 💡 Our findings underscore the potential of PLGA nanocapsules as a powerful tool for noninvasive pulmonary delivery, offering new avenues for addressing Acute Respiratory Distress Syndrome (ARDS) and other pulmonary conditions. 🔗 Read the full article here: https://lnkd.in/dKyyTU7x 💙 A huge thank you to our dedicated team and collaborators who made this research possible. We look forward to continuing our work in advancing nanomedicine for respiratory health! #Nanomedicine #LungHealth #ARDS #Pharmaceuticals #DrugDelivery #ScientificResearch #Publication #SmallScience