ENTITY – Page 8

Spotlight on LGBTQ+ Leaders Driving Change in Life Sciences

3 weeks ago talkbio0Tagged Biological Science Disciplines, Biopharma, Diversity, Fellows, GUTC, Health Workforce, Inclusion, Leadership, LGBTQ+ professionals, Monthly (qualifier value), philanthropy

LGBTQ+ professionals; life sciences; biopharma; leadership; Diversity and Inclusion; Health Workforce; GUTC Fellows; philanthropy; Pride Month

Pharma Companies Eye ‘First Sale’ Rule to Lessen Tariff Costs Amid New US Trade Measures

3 weeks ago talkbio0Tagged customs loophole, drug import duties, Drug Industry, first, minimis exemption, sale rule, tariff avoidance, trade compliance, Trump administration, U.S., US tariffs

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

Post-Hoc: AI bio needs to heed the overhyped history of CRISPR

3 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, overhype, reproductive health biotech

CRISPR; AI in biotech; overhype; gene editing; reproductive health biotech

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

3 weeks ago talkbio0Tagged Advisory Committees, enzalutamide, expansion, Inhibitor, Labels (device), Malignant neoplasm of prostate, mCRPC, PARP1 gene, Pfizer, talazoparib, Talzenna, unanimous vote, United States Food and Drug Administration

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

Eikon Therapeutics Implements Second Major Staff Reduction in Under Two Years

3 weeks ago talkbio0Tagged layoffs, research instrument development, Roger Perlmutter, Staff, Workforce reduction

Eikon Therapeutics; layoffs; biotech; staff cuts; funding cuts; research instrument development; workforce reduction; Roger Perlmutter

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

3 weeks 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

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

3 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

FDA Advisory Committee Splits Votes on Genentech and J&J Cancer Drugs

3 weeks 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

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

3 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

3 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