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AskBio Receives FDA Fast Track Designation for AB-1002 Investigational Gene Therapy Program in Congestive Heart Failure

AB-1002 is being studied for the treatment of adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms

United statesCanwen jiangChristian rommelCenters for diseaseDrug administrationAsklepios biopharmaceutical incBayer agAmerican heart associationHead of researchFast track programBayer pharmaceuticals divisionGlobal public health burden of heart failureAsklepios biopharmaceuticalFast track designationTrack designationChief development officer

AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

·         With a mortality rate of 20-30% for sepsis and 30-50% for septic shock in developed countries, sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths worldwide·        .

Bruxelles capitaleEva bauer juliaStephan wittePeter pickkersRichard jonesDepartment of intensive care medicineWorld health organizationRadboud centerMc servicesDrug administrationFast trackFast trackdesignationAccelerated approvalPriority reviewIntensive care medicineInfectious diseases

AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

With a mortality rate of 20-30% for sepsis and 30-50% for septic shock in developed countries, sepsis represents an enormous public health burden .

Bruxelles capitaleStephan witteRichard jonesEva bauer juliaPeter pickkersWorld health organizationRadboud centerDrug administrationDepartment of intensive care medicineMc servicesFast trackAccelerated approvalPriority reviewIntensive care medicineInfectious diseases

Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency

Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency
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United statesUnited arab emiratesInozyme pharmastefan rileyInozyme pharmaDouglasa trecoSmithsolve matt peraZulf mughalBiomarker dataexploratoryCompany or inozymeCorporate communicationsDrug administrationInozyme pharma incEuropean medicines agencyNatural history studiesthe companyInternational numberExchange commission

What We re Reading: Accelerated Approval Questions; Trump Position on Abortion Ban; Therapists Raising Fees

There is discrepancy between the FDA’s accelerated approval decisions and clinical benefits in cancer treatments; former President Donald Trump’s video statement avoids a clear stance on national abortion legislation; 40% of therapists say they will increase their fees this year.

Roev wadeDonald trumpCancer drugs granted accelerated approvalSupreme courtAssociated pressLimited benefitsCancer drugs granted acceleratedDefers abortion decisionTruth socialPresident donald trumpAccelerated approval