Manufactured Object – Page 4 – Talk Bio

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Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

2 months ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action

Endpoints 11: The Most Promising Biotech Companies to Watch in 2025 Revealed Live in Boston

2 months ago talkbio0Tagged biotech industry, City of Boston, Endpoints

Endpoints 11; biotech companies; Boston; biotech awards; biotech industry

Vertex, NHS England Finalize Reimbursement Deal for CF Drug Alyftrek

2 months ago talkbio0Tagged ALYFTREK, Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation, Health care facility, NHS England, Nitroglycerin/Sodium Citrate/Ethanol Solution, Reimbursement, triple therapy, UK

Vertex; NHS England; Alyftrek; cystic fibrosis; reimbursement agreement; triple therapy; CFTR gene mutation; NICE; UK healthcare

Trump Threatens 200% Tariffs on Pharma Imports, Proposes 1-Year Grace Period for Onshoring

2 months ago talkbio0Tagged 200, Biopharma, drug imports, grace, Investments, Menstruation, onshoring, Pharma, pharmaceutical tariffs, Policy, tariff, Transplant Registry Unified Management Program, U.S.

Trump; pharmaceutical tariffs; 200% tariff; grace period; pharma manufacturing; drug imports; US supply chain; onshoring; policy; biopharma investments

BioNTech Halts Cell Therapy Manufacturing at Maryland Site, Lays Off Dozens

3 months ago talkbio0Tagged BioNTech, BNT211, Cancer Therapeutic Procedure, CAR-T, Cell Therapy, Clinical Trials, Gaithersburg, layoffs, Manufacturing Facilities, Maryland (geographic location)

BioNTech; cell therapy; Maryland; layoffs; CAR-T; BNT211; Gaithersburg; manufacturing facility; cancer therapy; clinical trial

Lark Health Launches LarkVantage: AI-Powered Platform to Manage GLP-1 Costs

3 months ago talkbio0Tagged Administration occupational activities, Aortic Valve Insufficiency, authorization, cost management, Gibbs, Glucagon-Like Peptide 1, Health care facility, Health Planning, Lark Health, LarkVantage, Pharmacy Benefit Manager, utilization qualifier, Weight maintenance regimen

Lark Health; LarkVantage; GLP-1 cost management; AI healthcare; prior authorization; utilization management; PBM; health plans; weight management; Matthew Gibbs

Gilead Lays Off 36 Employees After Cancelling Oceanside, California Expansion

3 months ago talkbio0Tagged Biological Factors, biotech industry, California, co-location, expansion, Facility (object), Foster City, Gilead Sciences, layoffs, Oceanside

Gilead Sciences; layoffs; Oceanside; California; biologics; facility expansion; job cuts; biotech industry; co-location; Foster City

AstraZeneca and CSPC Enter $5.3B AI-Driven Drug Discovery Pact in China

3 months ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, AstraZeneca, China, Chronic disease, Dosage Forms, Drug Discovery, GZMH gene, Investments, oral therapies, Partnership, R&D, research

AstraZeneca; CSPC Pharmaceutical; AI research; drug discovery; chronic diseases; China; $5.3 billion; oral therapies; partnership; R&D investment

UCB Announces Major Investment to Expand US Biologics Manufacturing Capacity

3 months ago talkbio0Tagged Biological Factors, biomanufacturing, economic impact, expansion, Investments, Manufacturing, U.S., UCB

UCB; biologics manufacturing; US expansion; biomanufacturing; biopharmaceutical; investment; jobs; economic impact

FDA Reinstates Generic Drug Policy Group After April Firings

3 months ago talkbio0Tagged Administrative action, Departure - action, development aspects, drug price, Generic Drugs, layoffs, Office, Policy, reinstatement, Transection (procedure), United States Food and Drug Administration

FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave