research – Talk Bio

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

3 days ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights

5 days ago talkbio0Tagged Capitalization, clinical-stage biopharma, development aspects, exophthalmos producing substance, financial results, Impaired, Market, net loss, Nkarta, Operating expenses, Q3, research

Nkarta; Q3 2025 financial results; net loss; operating expenses; EPS; research and development; impairment; market capitalization; clinical-stage biopharma; corporate highlights

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

1 week ago talkbio0Tagged BEACON-IPF, cash reserves, Clinical Trials, development expenses, financial results, net loss, oncology program, Oxford Finance, Pliant Therapeutics, PLN-101095, Q3, research

Pliant Therapeutics; Q3 2025 financial results; PLN-101095; oncology program; BEACON-IPF trial; net loss; research and development expenses; cash reserves; Oxford Finance loan repayment

Roche Pays $55M Upfront to Manifold Bio in $2B+ Deal for AI-Guided Next-Gen Brain Shuttles

2 weeks ago talkbio0Tagged AI drug discovery, BBB, Blood - brain barrier anatomy, Manifold Bio, milestones, Neurological diseases, research, Roche (company), shuttles, therapeutic payloads, upfront payment

Roche; Manifold Bio; blood-brain barrier; BBB shuttles; neurological diseases; AI drug discovery; research deal; upfront payment; milestones; therapeutic payloads

‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

2 weeks ago talkbio0Tagged agency turmoil, Center for Drug Evaluation, Center for Drug Evaluation and Research, George Tidmarsh, Kevin Tang, Leadership, personal conduct probe, Regulatory Authority, research, resignation, United States Food and Drug Administration

FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority

Vinay Prasad Returns to the FDA With Fewer Titles and a Lower Profile

3 months ago talkbio0Tagged Center for Biologics Evaluation and Research, gene therapy, Lower Profile, Prasad, research, Return to (contextual qualifier) (qualifier value), Titles, United States Food and Drug Administration, vaccine regulation, Vinay

Vinay Prasad; FDA; return; Center for Biologics Evaluation and Research (CBER); fewer titles; lower profile; gene therapy; vaccine regulation

Data Lakes & FAIR Principles: Making Scientific Data Accessible and Actionable

3 months ago talkbio0Tagged accessible, Data Lakes, Data Management, Fair Language Proficiency, Findable, Interoperable, Principles, research, Scientific Data

Data Lakes; FAIR Principles; Scientific Data; Findable; Accessible; Interoperable; Reusable; Research Data Management

AstraZeneca and CSPC Enter $5.3B AI-Driven Drug Discovery Pact in China

5 months ago talkbio0Tagged Artificial Intelligence, AstraZeneca, China, Chronic disease, Dosage Forms, Drug Discovery, GZMH gene, Investments, oral therapies, Partnership, R&D, research

AstraZeneca; CSPC Pharmaceutical; AI research; drug discovery; chronic diseases; China; $5.3 billion; oral therapies; partnership; R&D investment

Sanofi Announces $20 Billion US Investment Over Five Years

6 months ago talkbio0Tagged Big Pharma, development aspects, domestic partnerships, Drug Industry, Investments, Manufacturing, research, sanofi, Surgical construction, tariffs, U.S.

Sanofi; $20 billion investment; US pharmaceutical industry; manufacturing; research and development; tariffs; job creation; Big Pharma; domestic partnerships

Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

6 months ago talkbio0Tagged Biosafety, Clinical Trials, Collaboration, Efficiency, Ethics Committees, Research, Homo sapiens, IBC, multi-institutional research, regulatory, research, streamlined review

Clinical trials, IRB, IBC, collaboration, streamlined review, multi-institutional research, regulatory efficiency, research acceleration, biosafety, human subject protection