May 21, 2025 – Talk Bio

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FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

4 months ago talkbio0Tagged Clinical Trials, Invasive, Malignant neoplasm of urinary bladder, mitomycin, Non-Muscle, Oncologic Drugs Advisory Committee, Pharma, RCT, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen

FDA; UroGen Pharma; UGN-102; bladder cancer; Oncologic Drugs Advisory Committee; mitomycin; RCT; non–muscle invasive bladder cancer; clinical trials

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

4 months 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 Advisory Committee Splits Votes on Genentech and J&J Cancer Drugs

4 months ago talkbio0Tagged Advisory Committees, applicability, cancer drugs, Clinical Trials, Columvi, genentech, J&J, ODAC, STARGLO, United States Food and Drug Administration, Voting

FDA; advisory committee; Genentech; J&J; cancer drugs; Columvi; ODAC; clinical trials; diffuse large B-cell lymphoma; applicability; STARGLO; voting

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

4 months 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

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

4 months 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

Genentech Bets Again on Orionis With Potential $2B+ in Crowded Molecular Glue Space

4 months ago talkbio0Tagged Allo-Glue platform, Drug Discovery, genentech, Malignant Neoplasms, molecular glue, Neoplasms, Orionis Biosciences, Partnership, protein degraders

Genentech; Orionis Biosciences; molecular glue; oncology; drug discovery; cancer; partnership; biotech; protein degraders; Allo-Glue platform

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

4 months 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