talkbio – Page 7

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

2 weeks ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

Amgen’s Repatha Cholesterol-Lowering Shot Poised for Sales Boost After Landmark CV Prevention Trial Success

2 weeks ago talkbio0Tagged amgen, cardiovascular trial, cholesterol-lowering, Heart Diseases, LDL Cholesterol Lipoproteins, PCSK9 inhibitor, Primary Prevention, Repatha, Sales - occupational activity, VESALIUS-CV

Amgen; Repatha; cholesterol-lowering; PCSK9 inhibitor; cardiovascular trial; VESALIUS-CV; primary prevention; heart disease; sales; LDL cholesterol

Trump Administration and Pfizer Strike ‘Most Favored Nation’ Drug Price Deal

2 weeks ago talkbio0Tagged AmericasMedicines.com, Direct-to-Consumer, Drug Industry, drug price, Medicaid, Nation, Pfizer, PhRMA, Transplant Registry Unified Management Program, TrumpRx

Trump; Pfizer; most favored nation; drug prices; Medicaid; TrumpRx; direct-to-consumer; pharmaceutical industry; PhRMA; AmericasMedicines.com

Ansa Biotechnologies Raises $54.4M in Series B to Scale US DNA Synthesis Manufacturing

2 weeks ago talkbio0Tagged Ansa Biotechnologies, Biotechnology, Cerberus Ventures, DNA Replication, Manufacturing, Series B financing, synthetic construct, U.S.

Ansa Biotechnologies; Series B financing; DNA synthesis; Cerberus Ventures; US manufacturing; biotechnology; synthetic DNA; fundraising

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

2 weeks ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

Aerska Launches with $21M to Use Brain ‘Shuttles’ for RNAi Delivery in Neurological Diseases

2 weeks ago talkbio0Tagged Aerska, Alzheimer 's, antibody-oligonucleotide, Blood - brain barrier anatomy, brain shuttles, Gene Silencing, Immunostimulating conjugate (antigen), Irish (ethnic group), Neurological diseases, Parkinson 's, Precision Medicine, RNA Interference

Aerska; Irish biotech; RNA interference (RNAi); brain shuttles; blood-brain barrier; neurological diseases; Alzheimer’s; Parkinson’s; gene silencing; precision medicine; antibody-oligonucleotide conjugates

Halozyme to Acquire Elektrofi for $750 Million, Expanding Drug Delivery Capabilities

2 weeks ago talkbio0Tagged Acquisition, Biological Factors, Drug Delivery Systems, Elektrofi, Halozyme, Hypercon, microparticle technology, milestone payments, subcutaneous delivery

Halozyme Therapeutics; Elektrofi; acquisition; drug delivery; Hypercon; biologics; subcutaneous delivery; milestone payments; microparticle technology; Q4 2025