PERSON – Page 5

Ousted ACIP Members Criticize RFK Jr.’s ‘Destabilizing’ Changes to U.S. Vaccine Policy

1 month ago talkbio0Tagged ACIP, CDC, Centers for Disease Control and Prevention (U.S.), Committee, Decision, Employment Termination, Policy, public health medicine (field), Recommendation, RFK Jr., Vaccines

ACIP; RFK Jr.; vaccine policy; CDC; committee dismissal; public health; vaccine recommendations; destabilizing decisions

FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

1 month ago talkbio0Tagged Andembry, Angioedemas, Hereditary, Approved, dosing, factor XIIa, garadacimab-gxii, Inhibitor, SMPX gene, Subcutaneous Injections, Takeda, Takhzyro, United States Food and Drug Administration

Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection

Lilly Makes All Zepbound Doses Available via Direct Pay Program

1 month ago talkbio0Tagged Availability of, Dosage, eli lilly, LillyDirect, Obesity, pharmacy platform, Zepbound

Zepbound; Eli Lilly; direct pay; LillyDirect; tirzepatide; obesity medication; dose availability; pharmacy platform

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

1 month ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment

Bristol Myers Squibb Hires Goldman Sachs Biotech Analyst Chris Shibutani as Chief Strategy Officer

1 month ago talkbio0Tagged Big Pharma, Chris Shibutani, Corporate, external partnerships, Goldman Sachs, Long-Term Strategy, Myers, squibb

Bristol Myers Squibb; Chris Shibutani; Goldman Sachs; Chief Strategy Officer; long-term strategy; biotech analyst; Big Pharma; external partnerships; corporate strategy

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

1 month ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

FDA Launches AI Tool to Accelerate and Transform Drug Review Processes

1 month ago talkbio0Tagged AI tool, application assessment, Automation, drug review, Elsa, Generative AI, regulatory science, United States Food and Drug Administration

FDA; AI tool; drug review; rapid review; generative AI; regulatory science; Elsa; automation; application assessment

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

1 month ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor

FDA Leaders Anticipate Imminent Drug Approval Decisions

2 months ago talkbio0Tagged approvals, Drug Approval, Leadership, PDUFA, regulatory decision, United States Food and Drug Administration

FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

2 months ago talkbio0Tagged Biopharma, country-of-origin labeling, digital quality systems, forced labor compliance, green manufacturing, import rules, Manufacturing, regulatory, Serialization, Trump administration tariffs, United States Food and Drug Administration

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization