Patient or Disabled Group – Page 10

Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy

1 year ago talkbio0Tagged Accelerated, Advocacy, Approved, Clinical Trials, DMD, Duchenne, Effectiveness, gene therapy, Muscular Dystrophy, Muscular Dystrophy, Duchenne, Regulation of biological process, Safety, United States Food and Drug Administration

FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.

The Closure of Walmart Health Highlights Significant Hurdles for Retail Health Innovators

1 year ago talkbio0Tagged accessibility, competition, disruptors, Engaged to be married, Health, Health care facility, innovation, Landscapes, Reparative closure, Walmart Health

Walmart Health, retail health, disruptors, challenges, closure, innovation, healthcare, accessibility, competition, patient engagement, healthcare landscape.

Cigna’s Evernorth Pushes for Increased Humira Biosimilar Adoption

2 years ago talkbio0Tagged AbbVie, Biosimilars, Cigna, Evernorth, Financial cost, Financial savings, Health care facility, Humira, Pharmaceutical Services

Cigna, Evernorth, Humira, biosimilars, healthcare, pharmacy services, cost savings, patient access, AbbVie

FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

2 years ago talkbio0Tagged Adolescent (age group), Adults/, Approved, Condoms, Male, COVID19 (disease), Emergency Use Authorization, Half-Life Extended Monoclonal Antibody, immune compromise, Immunocompromised Host, Invivyd, Moderate (severity modifier), Pemgarda, pemivibart, Pre-Exposure Prophylaxis, Prophylactic treatment, Severe (severity modifier), United States Food and Drug Administration, VYD222

Invivyd, Pemgarda (pemivibart; formerly VYD222), Half-Life Extended Monoclonal Antibody, COVID-19 Prophylactic, Immunocompromised Patients, Emergency Use Authorization (EUA), FDA Approval, Moderate to Severe Immune Compromise, Pre-exposure Prophylaxis (Prevention) of COVID-19 in Adults/ Adolescents

FDA Grants First Approval for Orchard Therapeutics’ Gene Therapy Lenmeldy in Treating Rare Pediatric Neuron Disease

2 years ago talkbio0Tagged Approved, Autologous Gene Therapy, Infantile/, Juvenile, Lenmeldy, Leukodystrophy, Metachromatic, Orchard, Pre-Symptomatic Late, Rare Pediatric Disease, United States Food and Drug Administration

Orchard Therapeutics, Lenmeldy, FDA Approval, Metachromatic Leukodystrophy (MLD), Rare Pediatric Disease, Autologous Gene Therapy, Pre-Symptomatic Late Infantile/ Early Juvenile Patients

AstraZeneca and GSK Join Boehringer Ingelheim in Capping Out-of-Pocket Inhaler Costs at $35 per Month

2 years ago talkbio0Tagged accessibility, AstraZeneca, GlaxoSmithKline/ Boehringer, Ingelheim, out-of-pocket costs/ cap/, Prices, U.S./ congressional

AstraZeneca/ GlaxoSmithKline/ Boehringer Ingelheim/ inhaler/ out-of-pocket costs/ cap/ $35/ asthma/ COPD/ price reduction/ drug pricing/ U.S./ congressional scrutiny/ patient affordability/ medication accessibility.

FDA Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment

2 years ago talkbio0Tagged Accelerated clearance, Adult, Antibody-Drug, Approved, Madrigal Pharmaceuticals, metabolic dysfunction-associated steatohepatitis, moderate-to-advanced liver fibrosis, Non-cirrhotic, resmetirom, Rezdiffra, United States Food and Drug Administration

FDA approval, Madrigal Pharmaceuticals, Rezdiffra (resmetirom), Metabolic dysfunction-associated steatohepatitis (MASH), Accelerated clearance, Adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis