October 2025 – Page 5

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

1 week ago talkbio0Tagged AbbVie, amgen, Application procedure, biology (field), drug applications, funding lapse, Government, J&J, Myers Squibb, Pfizer, pharmaceutical delays, shutdown, United States Food and Drug Administration, user fees

FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer

Behind-the-Scenes Details of 89bio’s $2.4B Deal with Roche

1 week ago talkbio0Tagged biotech acquisition, Conditional, Deal Structure, Liver diseases, MASH, milestone payments, pegozafermin, Roche (company)

Roche; 89bio; pegozafermin; MASH; liver disease; contingent value rights; biotech acquisition; pharmaceuticals; deal structure; milestone payments

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

1 week 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

1 week 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

1 week 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

1 week 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

1 week 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

1 week 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

1 week 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

Curtain Closes on Takeda’s Cell Therapy Efforts

1 week ago talkbio0Tagged Biological Factors, Cell Therapy, Gamma/Delta T-Lymphocyte, Impaired, research discontinuation, strategic shift, Takeda

Takeda; cell therapy; research discontinuation; impairment loss; gamma delta T-cell; strategic shift; biopharmaceuticals