Disease or Syndrome – Page 6

Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

3 weeks ago talkbio0Tagged Biologics License Application, Clinical Trials, COVID19 (disease), Effectiveness, Influenza, Moderna, mRNA-1083, Prices, United States Food and Drug Administration, Vaccines, Vaccines, Combined

Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price

Vinay Prasad’s First Major Policy: Challenging Covid Vaccine ‘Dogma’ at FDA

4 weeks ago talkbio0Tagged Clinical Trials, COVID19 (disease), Policy, Prasad, public health medicine (field), Recommendation, Regulatory Framework, United States Food and Drug Administration, Vaccines, Vinay

Vinay Prasad; FDA; Covid-19 vaccines; policy change; clinical trials; vaccine recommendations; public health; regulatory framework

‘Go ahead and do it’: Top RFK Jr. Deputy Dares Drugmakers Over Threats to Pull Manufacturing Amid Price Pressure

4 weeks ago talkbio0Tagged Big Pharma, Calley Means, CHARGE Syndrome, Drug Industry, drug price, executive order, HHS, Manufacturing, Prices, RFK Jr., Roche (company), threat

RFK Jr.; drug pricing; Calley Means; HHS; pharmaceutical industry; manufacturing threats; Roche; executive order; price limits; Big Pharma

FDA Institutes Stricter, Targeted COVID Vaccine Policy, Moving Away from ‘One-Size-Fits-All’ Approach

4 weeks ago talkbio0Tagged Clinical Trials, COVID19 (disease), Elderly (population group), Eligibility Determination, high-risk groups, Policy, public health medicine (field), United States Food and Drug Administration, Vaccines

FDA; COVID-19; vaccine policy; vaccine eligibility; clinical trials; high-risk groups; elderly; policy change; public health

Korro Bio Lays Off 20% of Workforce to Extend Runway for Genetic Medicine Trials and Novo Nordisk Partnership

4 weeks ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, Genetic Medicine, Korro Bio, KRRO-110, layoffs, Nordisk, restructuring, RNA Editing

Korro Bio; layoffs; biotech; genetic medicine; RNA editing; KRRO-110; Novo Nordisk; clinical trial funding; restructuring; AATD

CRISPR Therapeutics Partners with Sirius for siRNA Therapies, Expanding Beyond Gene Editing

4 weeks ago talkbio0Tagged Anticoagulants, biotech partnerships, Cardiovascular Diseases, Clustered Regularly Interspaced Short Palindromic Repeats, Factor XI, Gene Modification, RNA, Small Interfering, Sirius, SRSD107, thrombotic disease

CRISPR Therapeutics; Sirius Therapeutics; siRNA; gene editing; SRSD107; cardiovascular diseases; thrombotic disease; biotech partnerships; Factor XI; anticoagulant therapies

FDA Approves Novavax COVID Vaccine After Delay, Limits Use to Smaller High-Risk Population

4 weeks ago talkbio0Tagged Approved, COVID19 (disease), Elderly (population group), Health conditions:-:Point in time:^Patient:-, Novavax, Nuvaxovid, protein-based vaccine, restricted population, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; Nuvaxovid; restricted population; protein-based vaccine; older adults; underlying health conditions

Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection

4 weeks ago talkbio0Tagged Aldose Reductase Inhibitor, Apply, Cautionary Warning, Classical galactosemia, clinical trial conduct, Govorestat, Infrequent, Rejection, United States Food and Drug Administration

Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter

BioMarin Acquires Inozyme Pharma for $270M, Gaining Phase 3 Rare Disease Therapy

4 weeks ago talkbio0Tagged Acquisition, BioMarin, Deficiency, ENPP1 gene, Enzyme Replacement Therapy, Infrequent, Inozyme, INZ-701, Pharma, Phase 3 clinical trial

BioMarin; Inozyme Pharma; acquisition; rare disease; INZ-701; ENPP1 Deficiency; enzyme replacement therapy; Phase 3 clinical trial

Novo Nordisk CEO Departs Amid Weight-Loss Drug Market Pressures; Flagship Biotech Appoints CEO from Scholar Rock

4 weeks ago talkbio0Tagged Appointments, biotech, CEO, Challenge, departure - ActRelationshipType, Eli Lilly competition, Flagship, Lars Fruergaard Jørgensen, Market, Nordisk, Obesity, Scholar Rock

Novo Nordisk; CEO departure; Lars Fruergaard Jørgensen; obesity drugs; weight-loss market; Eli Lilly competition; market challenges; Flagship Biotech; CEO appointment; Scholar Rock