Oncology

Phase 1/2 BRUIN Study of Pirtobrutinib

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Pirtobrutinib Monotherapy: A Promising Beacon of Efficacy and Safety in Relapsed/Refractory Follicular Lymphoma Patients

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Collagen Matrix FDA 510(k) approval for Fibrillar Collagen Wound Dressing; Roche’s cancer diagnostics ULTRA PLUS system launch; Insightec IDE Approval for Prostate Cancer; JustLight plc. trial of Sunflower Rx for Alzheimer’s disease; Thoraflex Hybrid Device Implantation in the United States; FDA 510(k) Clearance for the DABRA 2.0 Catheter

Pharma News for Sanofi, Bayer, Spero

AstraZeneca’s Imfinzi Shows Positive Results; Novartis Announces Results of Tislelizumab; FDA Grants Orphan Drug Designation to Evorpacept; EU Approves Sanofi’s Xenpozyme; Bayer’s Kerendia Approves in China; FDA Breakthrough Therapy Designation to Talquetamab; FDA Puts Clinical Hold on Sanofi’s Tolebrutinib; FDA Rejects Spero’s Tebipenem

MedTech News for LumiThera, 3Spine and Teleflex

LumiThera’s US LIGHTSITE III Trial; First Patient Enrolled in Vascular Closure Device Study of Teleflex; Varian’s Flash Technology Clinical Trial, FAST-02; 3Spine’s MOTUS Device; Illumina’s Research Test to Detect Tumor Genome; Acutus Medical’s AcQCross Qx System

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Ipsen to Buy Epizyme; BioMarin’s Gene Therapy for Hemophilia; AbbVie’s Qulipta for Chronic Migraine; FDA Approves Breyanzi for R/R LBCL; NDA Filed for Elacestrant in ER+/HER2- Breast Cancer; EU Approval to Enhertu for Breast Cancer; FDA Approves Novartis’ BRAF-positive Tumor Combination; GSK’s Hepatitis B Vaccine, Bepirovirsen

MedTech Updates for Ibex and Senseonics

CE Mark to Ibex’s Gastric Cancer Detection System; Senseonics’s Eversense E3 Continuous Glucose Monitoring System; NEUSPERA’s NUVELLA SYSTEM; Conformal Medical Initiates CONFORM Pivotal Trial; Meridian Launches New qPCR Master Mixes for Stool Samples; Sentinel Diagnostics Launches SENTiFIT 800

Nanomedicine Transforming Healthcare Market Dynamics

How is Nanomedicine Transforming the Dynamics of the Healthcare Industry?

Biogen terminates ALS Pact with Karyopharm; AbbVie’s Immunological Drug Skyrizi; NICE Backs Astellas’ Oral Therapy Evrenzo; Roche’s Crenezumab Fails in Clinical Trial; FDA Grants Fast Track Designation to Dianhydrogalactitol; Sierra Oncology Submits NDA for Momelotinib

Pharma News and Updates for GSK, Roche, and Owkin

GSK’s RSV Vaccine Clears Phase III Test in Adults; Roche’s Tecentriq for Adjuvant NSCLC; Owkin Bags $ 180 million from BMS; EU Approves Roche’s Mosunetuzumab; Dostarlimab Elicits Clinical Complete Response in dMMR Rectal Cancer; FDA Backs Bluebird’s CALD Gene Therapy; Takeda’s Dengue Fever Vaccine TAK-003; FDA Approves Dupilumab

MedTech News and Updates for LumiraDx, Grail, and Insulet

REVIAN RED System Delivers Positive Results, Insulet’s Omnipod Provides Notable Improvement in Type 1 Diabetes, FDA Clearance to Cardio Flow’s FreedomFlow Guidewire; LumiraDx’s Cardiovascular Testing Portfolio; GRAIL-AstraZeneca to Develop Diagnostic Tests; ETHICON Launches Next Generation ECHELON 3000 Stapler

Pharma News for CG Oncology, Amgen, Elevar, and GSK

CG Oncology Teams Up With Merck & BMS; Parse Biosciences Partners With Molecular Diagnostics Korea; Amgen’s Olpasiran; Elevar Therapeutics Announces Results of Rivoceranib; FDA Approves GSK’s Measles Vaccine; Sage & Biogen Reveals Postpartum Depression Trial Result

Pharma News and Updates for BMS, Mirati, Roche, Dermavant, Merck

Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda

MedTech News Analysis for Accleus and Labcorp

Accleus’s Toro-L Interbody Fusion System; Labcorp’s New Test for Skin Cancer; SERA Prognostics’s Preterm Test; Endotronix’s SIRONA 2 Clinical Trial; Anumana’s AI Algorithm to Detect ECG Pulmonary Hypertension; Illumina’s Pan-cancer Companion Diagnostic

Pharma News For Sanofi, Bayer, Innoviva

PTC Therapeutics’ Gene Therapy Upstaza; Sanofi and Regeneron’s Dupixent; Bayer CAR-T Collaboration with Atara; FDA Accepts Biohaven’s Zavegepant; AbbVie Files FDA Approval for ABBV-951; Innoviva to Acquire Entasis; FDA Orphan Drug Designation to XMT-2056; FDA Approves Azacitidine for Juvenile Myelomonocytic Leukemia

Pharma News and Update for Incyte and Aptose

AstraZeneca’s Farxiga; Incyte’s Jakavi; FDA Fast Track Status to HM43239 for R/R AML; Idorsia’s Insomnia Drug Quviviq; EU Approves Kymirah For Follicular Lymphoma; Perrigo Acquires HRA Pharma; Janssen Submits Marketing Authorisation Application to EMA

MedTech News and Updates for GE, Vivalink, and Vektor

GE and Medtronic’s Collaboration; Vivalink’s Multi-Vital Blood Pressure Patch; Foldax’s TRIA Biopolymer Surgical Aortic Heart Valve; Vektor Medical’s vMap Clinical Validation Study; iSono’s ATUS System; Mirvie’s Test to Identify Risk of Preeclampsia

Pharma News and Updates for AstraZeneca, Supernus, and BMS

VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq

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