regulatory uncertainty

Getting to Yes: How Deal-Making Fuels Biotech Growth – 2025 Updates

1 month ago talkbio0Tagged Acquisitions, BATNA, biotech dealmaking, Licensing, mergers, patent cliffs, pharmaceutical negotiations, pipeline gaps, regulatory uncertainty, reputation, valuation, venture capital

biotech dealmaking; mergers and acquisitions; licensing; venture capital; BATNA; pharmaceutical negotiations; reputation; pipeline gaps; patent cliffs; valuation; regulatory uncertainty

DTC vs. DTP: Regulatory Uncertainty & Access Challenges Drive New Go-to-Market Models (2025 Update)

3 months ago talkbio0Tagged Access, Artificial Intelligence, Diphtheria-Tetanus-Pertussis Vaccine, Direct-to-Consumer, direct-to-patient, Ditiocarb, DTP, formulary restrictions, go-to-market models, OOP costs, pharmaceutical marketing, regulatory uncertainty, Rx abandonment, Telemedicine, United States Food and Drug Administration

DTC (Direct-to-Consumer); DTP (Direct-to-Patient); regulatory uncertainty; access challenges; pharmaceutical marketing; go-to-market models; FDA; Rx abandonment; formulary restrictions; OOP costs; telehealth; AI in marketing

ASCO25 Primer: Navigating Cancer R&D Amid Regulatory Uncertainty

5 months ago talkbio0Tagged ASCO25, Cancer Research, Changing, Diagnostics, expert, Immunotherapy, Neoplasms, perspectives, Policy, Precision Medicine, regulatory uncertainty

ASCO25; cancer research; oncology; regulatory uncertainty; immunotherapy; precision medicine; diagnostics; expert perspectives; policy changes

FDA Shakeup: Peter Marks’ Resignation Rattles Biotech Industry

7 months ago talkbio0Tagged Peter Marks, regulatory uncertainty, resignation, stocks, United States Food and Drug Administration

Peter Marks, FDA resignation, biotech stocks, regulatory uncertainty, drug approvals

“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”

2 years ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Antisense Therapy, Approved, Clinical Trials, masitinib, Patient advocacy, regulatory uncertainty, Relyvrio, risk-benefit analysis, United States Food and Drug Administration

ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy