ORG – Page 7 – Talk Bio

FDA Union Prepares for Negotiations as HHS Job Cuts Reshape Workforce

2 weeks ago talkbio0Tagged Advocacy, CHARGE Syndrome, employee layoffs, federal, Force, layoffs, Mediation, public health medicine (field), reduction in force, restructuring, Union, United States Food and Drug Administration

FDA layoffs, HHS restructuring, Union negotiations, Reduction in Force (RIF), Robert F. Kennedy Jr., FDA workforce reduction, HHS employee layoffs, Federal health agencies, Public health impact, Union advocacy

Amgen Secures Phase 3 Survival Data for Imdelltra in Small-Cell Lung Cancer, Strengthening Its Case for Full FDA Approval

2 weeks ago talkbio0Tagged amgen, Biological Factors, DLL3-targeting therapy, Imdelltra, Immunotherapy, Overall Survival, Phase 3 trial, SCLC, small-cell lung cancer

Imdelltra, Amgen, Small-cell lung cancer (SCLC), Phase 3 trial, Overall survival, DLL3-targeting therapy, Immunotherapy, Biopharmaceuticals

Verve’s 2nd swing at PCSK9 editing yields clean safety profile, teeing up Lilly opt-in decision

2 weeks ago talkbio0Tagged Safety, VERVE-102

VERVE-102, Safety

As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay

2 weeks ago talkbio0Tagged alternatives, Clinical Trials, gene therapy, Hemgenix, HYMPAVZI, Pfizer, SMPX gene

Hemgenix, SMPX gene, Pfizer, gene therapy, alternatives, HYMPAVZI, Clinical Trials

Tome Bio founders wrangle jumping genes to create new programmable gene insertion tool

2 weeks ago talkbio0Tagged Clustered Regularly Interspaced Short Palindromic Repeats, PGI, Retrotransposons, Technology

PGI, Technology, Retrotransposons, Clustered Regularly Interspaced Short Palindromic Repeats

Biotech and Pharma Job Cuts: Opthea and Pfizer Restructure Amid Industry Challenges

2 weeks ago talkbio0Tagged biotech, Clinical Trial Failures, Cost savings programs, Glycogen storage disease type II, Industry, Opthea layoffs, Pfizer, Pfizer staff, Pharma, restructuring

Opthea layoffs 2025 , Pfizer staff reduction , Biotech job cuts , Pharma restructuring , Clinical trial failures , Wet AMD treatment , Cost savings programs , Pfizer San Diego layoffs , Biotech industry challenges

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs

2 weeks ago talkbio0Tagged Biopharma regulatory issues, Budgets, delays, drug review, HHS layoffs, layoffs, Medical Devices, operational, PDUFA, regulatory, RFK Jr., United States Food and Drug Administration, user fee

FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions

Novartis to invest $23B in manufacturing so ‘all key medicines’ can be made in the US

2 weeks ago talkbio0Tagged Biological Factors, Investments, Manufacture, Novartis, production, United States

Novartis, United States, Investments, Manufacture, production, Biological Factors, Novartis

Navigating Challenges: Keros and Tempest Aim to Stabilize and Strategize for Growth

2 weeks ago talkbio0Tagged biopharmaceutical sector, Biotechnology, Clinical Trials, Corporate, financial, Infantile Neuroaxonal Dystrophy, Investments, restructuring, stockholder, strategic alternatives

Keros Therapeutics , Strategic alternatives , Financial challenges , Biopharmaceutical sector , Stockholder rights plan , Clinical trials , Tempest Therapeutics , Corporate restructuring , Biotechnology investments

Dexcom extends G7 sensor wear time to 15 days with latest FDA nod

2 weeks ago talkbio0Tagged Accurate (qualifier), Continuous glucose monitoring, day, Extension, MSH5 gene, sensor (device), United States Food and Drug Administration, wear time

United States Food and Drug Administration, sensor (device), Continuous glucose monitoring, MSH5 gene, Accurate (qualifier), Extension, wear time, day