talkbio – Page 20

first sale rule; pharmaceutical industry; US tariffs; customs loophole; drug import duties; tariff avoidance; trade compliance; Trump administration; de minimis exemption

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

2 months 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

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

2 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

2 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

2 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

2 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