Professional or Occupational Group

Rakovina Therapeutics Announces Q3 2025 Financial Results and Corporate Update

1 week ago talkbio0Tagged AI-powered, ATR Inhibitor, Clinical Nurse Specialists, Conferences, corporate milestones, development expenses, Ditiocarb, Drug Discovery, Eligibility Determination, financial results, Investments, NanoPalm joint-venture, net loss, Penetration, Q3, Rakovina, research

Rakovina Therapeutics; Q3 2025; financial results; net loss; research and development expenses; AI-powered drug discovery; ATR inhibitor; CNS penetration; corporate milestones; NanoPalm joint-venture; investment conference; DTC eligibility

White House Requests Resignation of Top FDA Aide, Prompting Tensions with Commissioner Makary

2 weeks ago talkbio0Tagged CHARGE Syndrome, controversy, internal tensions, management technique, Marty Makary, resignation, Sanjula Jain-Nagpal, United States Food and Drug Administration, White House, Workforce - population group

FDA; White House; Marty Makary; Sanjula Jain-Nagpal; resignation; HHS; staffing controversy; Robert F. Kennedy Jr.; management style; internal tensions

Edgewise Therapeutics Appoints Christopher Martin to its Board of Directors

3 weeks ago talkbio0Tagged Acquisition, Becker Muscular Dystrophy, board of directors, cardiovascular asset, Christopher Martin, commercial, Edgewise Therapeutics, executives, Leadership, Merck, Verona Pharma

Edgewise Therapeutics; Christopher Martin; Board of Directors; biotech executive; commercial leadership; Becker muscular dystrophy; cardiovascular asset; Verona Pharma; Merck acquisition

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

3 weeks ago talkbio0Tagged acceptance, ARROS-1 trial, Breakthrough Therapy, Clinical Nurse Specialists, Identifier, New Drug Application, Non-Small Cell Lung Carcinoma, Nuvalent, orphan drug designation, PDUFA, Penetration, pre-treated, Protein-tyrosine kinase inhibitor, ROS1-positive, United States Food and Drug Administration, zidesamtinib

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

Cylinder Health Appoints New Head of Gut-Brain Health and Expands Clinical Advisory Board

4 weeks ago talkbio0Tagged Clinical Advisory Board, Cylinder Health, Digital digestive health, Employee, GI care, Grace Niu, Gut-Brain Health, Hamed Khalili

Cylinder Health; Gut-Brain Health; Clinical Advisory Board; Grace Niu; Dr. Hamed Khalili; Digital digestive health; GI care; Employee health

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

4 weeks 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

Novo Execs Face Skeptical Analysts Amid Metsera Buyout Drama

1 month ago talkbio0Tagged Acquisition, analysts, Antitrust, Buyout, CEO Mike, lawsuit, Metsera, Novo Nordisk, Obesity, Pfizer

Novo Nordisk; Metsera; acquisition; Pfizer; buyout; obesity drugs; analysts; lawsuit; antitrust; CEO Mike Doustdar

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

1 month 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

Cigna Announces End to Drug Rebates for Many Health Plans Beginning in 2027

1 month ago talkbio0Tagged brand-name prescriptions, Cigna, drug price, drug rebates, Evernorth, Express Scripts, manager, Pharmaceutical Services, pharmacy reimbursement, Trump administration, upfront discounts

Cigna; drug rebates; pharmacy benefit manager; Evernorth; Express Scripts; upfront discounts; brand-name prescriptions; pharmacy reimbursement; Trump administration; drug pricing

Alkermes Acquires Avadel Pharmaceuticals for $2.1B, Gaining Sleep Drug LUMRYZ and Setting Strategic Evolution

2 months ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, Biological Factors, LUMRYZ, Narcolepsy, portfolio, premium, Rare Diseases, Sleep medicine specialist, strategic

Alkermes; Avadel Pharmaceuticals; acquisition; LUMRYZ; narcolepsy; sleep medicine; strategic portfolio; biopharmaceuticals; rare disease; deal premium