DATE – Talk Bio

From JP Morgan to the Next Wave: What’s Driving Biotech in 2026

7 hours ago talkbio0Tagged 2026, Artificial Intelligence, Drug Discovery, Hematology (discipline), Investments, J.P. Morgan Healthcare Conference, M&A activity, Neoplasms, Neuropsychology, regulatory science, trends qualifier

J.P. Morgan Healthcare Conference; biotech trends 2026; M&A activity; oncology; neuropsychology; hematology; artificial intelligence; drug discovery; investment; regulatory science

Novartis to Acquire RNA Drugmaker Avidity Biosciences in $12 Billion Deal

15 hours ago talkbio0Tagged 2026, Acquisition, AOC, Avidity Biosciences, Closed, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Facioscapulohumeral, MYOTONIC DYSTROPHY 1, Neuromuscular Diseases, Novartis, Platform, RNA therapeutics, SpinCo ', xRNA

Novartis; Avidity Biosciences; acquisition; RNA therapeutics; neuromuscular diseases; Duchenne muscular dystrophy; myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy; AOC platform; SpinCo; biotech; xRNA strategy; 2026 closing

ESMO Spotlight: Flagship ADCs move into early-stage cancer to validate chemo-displacement ambitions

5 days ago talkbio0Tagged 2025, ADCs, Administration occupational activities, Antibody-Drug Conjugates, Biological Markers, chemo-displacement, Datopotamab deruxtecan, Datroway, Enhertu, ESMO, HER2-positive, Limited stage (cancer stage), Malignant neoplasm of breast, Toxicity aspects, trastuzumab, Triple Negative Breast Neoplasms

ESMO 2025; antibody-drug conjugates; ADCs; early-stage cancer; chemo-displacement; trastuzumab deruxtecan; ENHERTU; datopotamab deruxtecan; DATROWAY; breast cancer; HER2-positive; triple-negative breast cancer; biomarkers; toxicity management

FDA Staffing Data Reveal Historic Departures in Fiscal 2025

5 days ago talkbio0Tagged CBER, CDER, departures, Disruption, Drug Approval, fiscal, layoffs, Organization administrative structures, Regulatory Impact, United States Food and Drug Administration, Workforce - population group

FDA; staffing; departures; fiscal 2025; layoffs; regulatory impact; CDER; CBER; drug approval delays; organizational disruption

GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

6 days ago talkbio0Tagged Complicated, cUTIs, HBr, IDWeek, non-inferiority, oral carbapenem, Phase 3 PIVOT-PO trial, Regulatory Filing, SmithKline Beecham, Spero Therapeutics, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission

CatalYm Presents Long-Term Phase 1/2a Data for Visugromab at ESMO 2025

7 days ago talkbio0Tagged CatalYm, CPI-refractory tumors, ESMO, Growth Differentiation Factor 15, Visugromab

CatalYm; Visugromab; ESMO 2025; CPI-Refractory Tumors; GDF-15

Friday Five: ESMO Looms Large, Arcus’ TIGIT Revival, and J&J’s Myeloma Advances

2 weeks ago talkbio0Tagged 2025, Arcus Biosciences, domvanalimab, ESMO, gastroesophageal adenocarcinoma, immuno-oncology, J&J, Multiple Myeloma, oncology clinical trials, Substance with programmed cell death protein 1 inhibitor mechanism of action (substance), TIGIT antibody, zimberelimab

ESMO 2025; Arcus Biosciences; domvanalimab; TIGIT antibody; gastroesophageal adenocarcinoma; J&J; multiple myeloma; immuno-oncology; PD-1 inhibitor; zimberelimab; oncology clinical trials

Takeda Expands De Novo Protein Research with Second AI-Driven Collaboration with Nabla Bio

2 weeks ago talkbio0Tagged AI drug discovery, antibody design, biopharmaceutical innovation, De Novo, JAM, Joint Atomic Model, multi-year collaboration, Nabla Bio, Takeda, therapeutic protein

Takeda; Nabla Bio; de novo protein design; AI drug discovery; Joint Atomic Model (JAM); multi-year collaboration; protein therapeutics; antibody design; biopharmaceutical innovation

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

2 weeks ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

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

4 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