ORG – Page 12 – Talk Bio

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

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

4 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

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

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

4 weeks 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 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

Tourmaline Bio’s Heart Drug Pacibekitug Shows Promise Against Cardiovascular Inflammation, Targets Competition with Novo, CSL

4 weeks ago talkbio0Tagged Cardiovascular system, heart drug, Inflammation, interleukin-6, Markers (device), Nordisk, pacibekitug, Phase 2 trial, SMPX gene, tourmaline, United States Food and Drug Administration

Tourmaline Bio; heart drug; pacibekitug; cardiovascular inflammation; inflammation markers; Novo Nordisk; CSL; Phase 2 trial; FDA; IL-6

RegenXBio Secures Up to $250 Million by Monetizing Royalties from Zolgensma and Two Gene Therapies

4 weeks ago talkbio0Tagged gene therapy, HealthCare Royalty, milestone payments, non-dilutive financing, Regenxbio, RGX-111, RGX-121, royalty monetization, Zolgensma

RegenXBio; Zolgensma; gene therapy; royalty monetization; HealthCare Royalty; RGX-121; RGX-111; non-dilutive financing; biotech; milestone payments

Prime Medicine CEO Exits Amidst Layoffs and Restructuring as Sole Clinical Gene Therapy Shelved

4 weeks ago talkbio0Tagged CEO, Clinical Trials, Exit, gene therapy, layoffs, pipeline pivot, PM359, Prime Editing, Prime Medicine, restructuring

Prime Medicine; CEO exit; gene therapy; layoffs; restructuring; biotech; PM359; prime editing; clinical trial; pipeline pivot