ORG – Page 42 – Talk Bio

FDA Reinstates Generic Drug Policy Group After April Firings

3 months ago talkbio0Tagged Administrative action, Departure - action, development aspects, drug price, Generic Drugs, layoffs, Office, Policy, reinstatement, Transection (procedure), United States Food and Drug Administration

FDA; generic drugs; policy office; Division of Policy Development; reinstatement; layoffs; drug prices; administrative leave

Merck Wins FDA Approval for RSV Antibody Drug, Intensifying Market Competition

3 months ago talkbio0Tagged Approved, AstraZeneca, competition, Enflonsia, Infant, Market, Merck, Monoclonal Antibodies, Respiratory syncytial virus, sanofi, United States Food and Drug Administration

Merck; FDA approval; RSV; monoclonal antibody; infants; Enflonsia; competitive market; Sanofi; AstraZeneca

Insmed’s ‘Unprecedented’ Phase 2 PAH Results Propel Stock and Next-Phase Plans

3 months ago talkbio0Tagged Clinical Trials, Insmed, PAH, Phase 3 trial, Pulmonary arterial hypertension, surge, TPTE2 gene, treprostinil palmitil inhalation powder

Insmed; PAH; TPIP; Phase 2b; clinical trial; treprostinil palmitil inhalation powder; stock surge; pulmonary arterial hypertension; Phase 3 trial; biotech

Inside ASCO 2025: Big Data Drops and a Towering Campaign – Key News Highlights

3 months ago talkbio0Tagged 2025, Artificial Intelligence, ASCO, Big Data, campaigns, Cancer Research, Clinical Oncology, erbB-2 Receptor, Malignant neoplasm of breast, Malignant neoplasm of lung

ASCO 2025; cancer research; big data; campaigns; clinical oncology; artificial intelligence; HER2; lung cancer; breast cancer; therapeutic vaccines

Recursion and Genentech Announce Significant Staff Layoffs in 2025

3 months ago talkbio0Tagged Biotech Layoffs, Drug Industry, genentech, pipeline cutbacks, Recursion

Recursion Pharmaceuticals; Genentech; biotech layoffs; workforce reduction; pipeline cutbacks; biotech funding; pharmaceutical industry; 2025 layoffs

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

3 months ago talkbio0Tagged Biopharma, country-of-origin labeling, digital quality systems, forced labor compliance, green manufacturing, import rules, Manufacturing, regulatory, Serialization, Trump administration tariffs, United States Food and Drug Administration

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization

Antares Therapeutics Launches with $177M to Tackle ‘Undruggable’ Targets After Scorpion Spinout

3 months ago talkbio0Tagged Antares, biotech spinoff, Eli Lilly acquisition, Neoplasms, Precision Medicine, preclinical pipeline, Scorpions, targets

Antares Therapeutics; Scorpion Therapeutics; biotech spinoff; $177M Series A; undruggable targets; oncology; precision medicine; Eli Lilly acquisition; preclinical pipeline

FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

3 months ago talkbio0Tagged Biktarvy, CD4 + T-cell, Clinical Trials, Gilead Sciences, GS-1720, GS-4182, HIV, Lenacapavir, Lymphocyte Count measurement, safety signal, Study on Hold, United States Food and Drug Administration

FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir

Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results

3 months ago talkbio0Tagged Clinical Trials, Engaged to be married, Insmed, PAH, Phase 3 Clinical Trials, Pulmonary arterial hypertension, TPTE2 gene, treprostinil palmitil inhalation powder, United States Food and Drug Administration

Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement

All innuendo and conspiracy: RFK Jr.’s vaccine advisory overhaul undermines vaccine confidence, experts say

3 months ago talkbio0Tagged ACIP, advisory, conspiracy, overhaul, public health medicine (field), RFK Jr., Self Confidence, Vaccines

RFK Jr.; vaccine advisory; ACIP; public health; conspiracy; confidence; overhaul