Phalguni Deswal
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Phalguni Deswal
@phalguniddw.bsky.social
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Editor - Drug and Device World
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MMI earns IDE approval from the US FDA for a groundbreaking robotic microsurgery trial targeting Alzheimer’s disease.

#News #Alzheimers #Surgery #Neurosurgery #Neurology #ClinicalTrial #FDAapproval #medicaldevice
FDA approves first robotic microsurgical study in Alzheimer’s
MMI earns FDA IDE approval for a groundbreaking robotic microsurgery trial targeting Alzheimer’s disease.
druganddeviceworld.com
November 7, 2025 at 10:55 AM
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Phenomix Sciences unveils new data at #Obesity"/hashtag/ObesityWeek2025" class="hover:underline text-blue-600 dark:text-sky-400 no-card-link">#ObesityWeek2025 showing its #MyPhenome test accurately predicts #GLP1 therapy response and obesity risk across diverse populations.

#News #PrecisionMedicine #ObesityResearch #HealthcareInnovation #Genomics #WeightLoss #Obesity
Phenomix expands evidence for GLP-1 response predicting MyPhenome test
New data show the MyPhenome test accurately predicts GLP-1 response and obesity risk across diverse populations.
druganddeviceworld.com
November 4, 2025 at 7:01 PM
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AAVantgarde Bio has raised $141M in Series B funding to advance gene therapies for Stargardt disease and Usher 1B syndrome — two inherited retinal diseases.

#News #Biotech #GeneTherapy #Ophthalmology #RareDiseases #LifeSciences #Stargardt #UsherSyndrome #HealthInnovation
AAVantgarde closes $141 million Series B for genetic disease therapies
The company plans to use the Series B funding to progress clinical trials for two genetic eye disorders, Stargardt disease and Usher 1B syndrome.
druganddeviceworld.com
November 4, 2025 at 6:16 PM
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Intensity Therapeutics's INT230-6, a tumor-injectable therapy, improved survival and showed abscopal effects in patients with advanced, refractory cancers.

#News #Cancer #Oncology #CancerResearch #IJTHS #CancerSurvival #ClinicalTrial
Intensity bolsters survival data for its intratumoral cancer therapy
The company’s stock shot up by approximately 394%, driven by the cancer therapy's strong overall survival and disease control results.
druganddeviceworld.com
November 4, 2025 at 5:32 PM
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🚀 CustoMED raises $6M to advance orthopedic surgery with AI-powered, 3D printed, patient-specific implants and tools. 🌍💡

#News #MedTech #AIinHealthcare #3DPrinting #OrthopedicSurgery #Innovation #HealthTech #StartupNews
CustoMED raises $6 million to expand AI-driven 3D printing for orthopedic surgery
Israeli medtech startup plans to use the funding to expand orthopedic applications, pursue global approvals, and scale manufacturing.
druganddeviceworld.com
October 29, 2025 at 5:15 PM
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Kymera Therapeutics has presented new preclinical data for its investigational drug, KT-579, an oral treatment designed to target a key driver of autoimmune diseases at ACT 2025 in Chicago.

#News #ClinicalResearch #autoimmune #lupus #SLE #arthritis #Sjögren's #ACR25
Kymera unveils preclinical data for oral autoimmune therapy
The Massachusetts-based company’s oral therapy KT-579 shows promise in preclinical models for lupus, rheumatoid arthritis, and Sjögren's syndrome.
druganddeviceworld.com
October 29, 2025 at 4:39 PM
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ten23 health and Neumirna Therapeutics have joined forces to advance NMT.001, an RNA-based therapy aimed at treating drug-resistant epilepsy.

#News #RNAtherapy #EpilepsyResearch #BiotechInnovation #ten23health #NeumirnaTherapeutics #Neurology #OligonucleotideTherapy #LifeSciences
ten23 health and Neumirna partner to advance RNA therapy for epilepsy
The collaboration seeks to advance NMT.001, an RNA-based therapy targeting microRNAs involved in drug-resistant epilepsy.
druganddeviceworld.com
October 28, 2025 at 4:24 PM
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Affibody's izokibep shows strong long-term results in psoriatic arthritis. New 52-week data from a Phase IIb/III trial presented at the ACR conference in Chicago

#News #PsoriaticArthritis #Rheumatology #ClinicalTrials #IL17 #Izokibep #ACR2025 #MedicalResearch
Affibody’s psoriatic arthritis therapy shows long-term promise
New 52-week data for izokibep in psoriatic arthritis show sustained efficacy and a favorable safety profile.
druganddeviceworld.com
October 27, 2025 at 5:16 PM
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News for prostate cancer patients in England and Wales — NICE has recommended Bayer’s Nubeqa plus ADT as a new NHS treatment option for men with hormone-sensitive metastatic prostate cancer.

#News #ProstateCancer #NICE #Bayer #Nubeqa #Darolutamide #CancerResearch #MensHealth #Oncology #NHS
Bayer scores UK NICE nod for Nubeqa in prostate cancer
NICE approves Bayer’s Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) for treating men with hormone-sensitive metastatic prostate cancer.
druganddeviceworld.com
October 27, 2025 at 4:49 PM
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A new Danish study shows cryoablation is just as effective as robotic surgery for kidney cancer — but 32% cheaper and with shorter hospital stays. 🌍💙❄️

#News #KidneyCancer #Cryoablation #HealthcareInnovation #MedicalResearch #CancerTreatment #BostonScientific
Boston Scientific study finds cryoablation more cost-effective than surgery
A Danish study finds cryoablation equally effective as robotic surgery for kidney cancer, but at 32% lower cost in patients with kidney cancer.
druganddeviceworld.com
October 27, 2025 at 9:58 AM
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Hyfe’s AI-powered Behavioral Cough Suppression Therapy reduced chronic cough frequency by over 40% and improved quality of life for 80% of participants.

#News #DigitalHealth #ClinicalResearch #AIHealthcare #ChronicCough #DigitalTherapeutics #HealthInnovation
Hyfe bolsters clinical data for chronic cough digital therapeutic
Hyfe’s AI-driven digital cough therapy reduced cough frequency by more than 40% in patients suffering from refractory and unexplained chronic cough.
druganddeviceworld.com
October 23, 2025 at 7:17 PM
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Telix Pharmaceuticals doses first patient in its SOLACE trial, testing a non-opioid radiopharmaceutical for advanced cancer pain.

#News #Oncoloy #ClinicalTrial #PainRelief #Research
Telix starts clinical trial for pain therapy for metastatic bone cancer
Telix Pharmaceuticals doses first patient in its SOLACE trial, testing a non-opioid radiopharmaceutical for advanced cancer pain.
druganddeviceworld.com
October 23, 2025 at 7:01 PM
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The FDA has approved a new use for Novo Nordisk's oral semaglutide, Rybelsus, expanding its label to reduce cardiovascular risk in high-risk adults with type 2 diabetes.

#News #diabetes #type2diabetes #Obesity #FDAapproval
FDA expands Novo Nordisk’s Rybelsus label to include cardiovascular risk reduction
The FDA has approved a new use for Novo Nordisk's oral semaglutide, expanding its label to reduce cardiovascular risk in high-risk adults with type 2 diabetes.
druganddeviceworld.com
October 22, 2025 at 5:11 PM
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Sanofi presents data from a Phase II clinical trial for an investigational targeted alpha therapy, AlphaMedix , as a treatment approach for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) at #ESMOef="/hashtag/ESMO25" class="hover:underline text-blue-600 dark:text-sky-400 no-card-link">#ESMO25.

#News #ESMO #CancerResearch #ClinicalTrial #cancer #oncology
ESMO 2025: Promising Phase II data for Sanofi’s alpha therapy
Investigational targeted alpha therapy AlphaMedix shows clinical activity in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
druganddeviceworld.com
October 21, 2025 at 4:33 PM
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Biotech firm I-Mab unveils global transformation, dual listing plan (US NASDAQ and Hong Kong Stock Exchange), and new focus under the NovaBridge Biosciences name.

#News #Rebrand #IPO #AMD #DME #CancerResearch
I-Mab to rebrand as NovaBridge Biosciences, pursue Hong Kong IPO
Biotech firm I-Mab unveils global transformation, dual listing plan, and new focus under the NovaBridge Biosciences name.
druganddeviceworld.com
October 21, 2025 at 1:54 PM
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Grifols plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.

#News #USAref="/hashtag/USAmanufacturing" class="hover:underline text-blue-600 dark:text-sky-400 no-card-link">#USAmanufacturing #manufacturing #onshoring #USA #Grifols #BloodTransusion
Grifols expands US diagnostic manufacturing with new San Diego facility
The company plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.
druganddeviceworld.com
October 21, 2025 at 1:37 PM
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Enterome’s OncoMimics immunotherapy EO2463 gains FDA Fast Track for follicular lymphoma, paving the way for Phase III trials in in the low-tumor-burden “watch-and-wait” setting.

#News #Lymphoma #FDAfasttrack #CancerResearch #Enterome #Oncology
Enterome’s lymphoma drug wins FDA fast track designation
The company is exploring EO2463’s efficacy in relapsed or refractory settings in a Phase I/II trial, with plans to start Phase III registrational trial in a “watch-and-wait” iNHL patient population
druganddeviceworld.com
October 21, 2025 at 1:16 PM
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AbbVie's New IBD data shows endoscopic healing in Crohn's predicts long-term success. Real-world evidence for UC treatment confirms rapid symptom relief. #News #CrohnsDisease #UlcerativeColitis #IBD #EndoscopicHealing
UEGW 2025: AbbVie bolsters IBD data for Rinvoq and Skyrizi
New data and lead investigators also reinforce the importance of treating beyond symptoms in Crohn's disease and ulcerative colitis.
druganddeviceworld.com
October 16, 2025 at 5:04 PM
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The US FDA granted the drug Breakthrough Therapy designation to Cidara Therapeutics’ its investigational influenza prophylactic, CD388, for the prevention of influenza A and B in high-risk adults and adolescents.

#News #FluTherapy #CD388
FDA grants breakthrough status to Cidara’s flu drug
Cidara Therapeutics' CD388, a long-acting influenza prophylactic, has previously received funding worth up to $339 million from the US BARDA.
druganddeviceworld.com
October 14, 2025 at 11:46 AM
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Synchrony Medical has announced the US launch of its LibAirty Airway Clearance System, a new at-home therapy designed to assist people living with chronic lung diseases such as chronic obstructive pulmonary disease (#COPD), #bronchiectasis, and cystic fibrosis.

#News #FDAapproval
Synchrony Medical launches LibAirty airway clearance system in the US
The FDA-cleared at-home system is designed to assist people living with chronic lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.
druganddeviceworld.com
October 14, 2025 at 11:26 AM
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The US FDA has approved an expanded indication for Teva Pharmaceuticals' Uzedy (risperidone) extended-release injectable suspension, authorizing its use for the maintenance treatment of bipolar I disorder (BD-I) in adults.
#News #Bipolar #Schizophrenia #FDAapproval
FDA expands Teva’s Uzedy approval to include bipolar I disorder
Teva’s long-acting subcutaneous formulation of Johnson and Johnson’s (J&J) Risperdal is already approved for schizophrenia.
druganddeviceworld.com
October 14, 2025 at 10:37 AM
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Grifols and Biotest have launched Yimmugo in the US. The FDA-approved intravenous immunoglobulin (IVIg) provides a new treatment option for individuals with primary immunodeficiencies (PID), expanding access to critical care.

#News #Yimmugo #Immunodeficiency #PID #RareDisease #FDAapproved
Grifols’ Biotest launches Yimmugo immunoglobulin therapy in US market
The US FDA approved the intravenous immunoglobulin (IVIg) therapy for the treatment of primary immunodeficiencies (PID) last year.
druganddeviceworld.com
October 10, 2025 at 7:05 PM
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Cidara Therapeutics secures up to $339M from BARDA to expand U.S. manufacturing and clinical development of CD388, its long-acting, non-vaccine influenza preventative designed to offer broad protection against all flu strains.
#News #BARDA #InfluenzaPrevention #CD388 #Biotech #PandemicPreparedness
Cidara secures $339m from BARDA for non-vaccine flu therapy
Cidara Therapeutics wins BARDA backing to expand US manufacturing and clinical development of its long-acting, non-vaccine influenza therapeutic, CD388.
druganddeviceworld.com
October 6, 2025 at 10:23 AM
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Resitu Medical's breast biopsy device, RESL09, receives US FDA 510(k) clearance. This minimally invasive tool for large tissue samples is a breakthrough for cancer diagnostics.

#News #BreastBiopsy #FDA #MedTech #Innovation #CancerDiagnostics #Diagnostics #Breastcancer
Resitu wins FDA clearance for breast biopsy device
Swedish MedTech firm has received US FDA 510(k) clearance for a handheld, single-use device designed for minimally invasive biopsy.
druganddeviceworld.com
October 2, 2025 at 4:26 PM
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🔬 New pooled Phase III data show Boehringer Ingelheim's nerandomilast may cut death risk in IPF & PPF by up to 59%.
#News #ERS2025 #PulmonaryFibrosis #IPF #PPF #ClinicalTrials #RespiratoryHealth
ERS 2025: Boehringer shared additional data for lung fibrosis therapy
Pooled Phase III data show nerandomilast may reduce death risk in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
druganddeviceworld.com
October 2, 2025 at 11:10 AM