July 2025 – Page 2

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

4 weeks ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints

4 weeks ago talkbio0Tagged ALS, Amyotrophic Lateral Sclerosis, Application procedure, Clinical Trials, Coya Therapeutics, Indonesian language, resource shortage, United States Food and Drug Administration

FDA; Coya Therapeutics; IND application; ALS; clinical trial delay; COYA 302; resource shortage

Jaypirca Demonstrates Superior Efficacy Over Imbruvica in BTK Inhibitor Clash for CLL/SLL

4 weeks ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, CLL-314, eli lilly, head-to-head trial, Imbruvica, Jaypirca, Progression-Free Survival

Jaypirca; Imbruvica; BTK inhibitor; chronic lymphocytic leukemia; small lymphocytic lymphoma; BRUIN CLL-314; overall response rate; progression-free survival; head-to-head trial; Eli Lilly

Merck Terminates Midstage Asset from $1.9B Pandion Acquisition over Lack of Clinical Benefit

4 weeks ago talkbio0Tagged asset termination, Benefit, biotech acquisition, Clinical Trials, lack of, Merck, Pandion

Merck; Pandion Therapeutics; asset termination; clinical trial; lack of benefit; biotech acquisition

Novo Nordisk Appoints New CEO and Reduces 2025 Sales Guidance

4 weeks ago talkbio0Tagged CEO, Changing, drug competition, growth outlook, guidance cut, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Sales - occupational activity, Transition Mutation

Novo Nordisk; CEO change; Maziar Mike Doustdar; 2025 sales guidance cut; growth outlook; leadership transition; obesity drug competition

ARTBIO Raises $132M Series B to Advance Alpha Radiotherapy Pipeline and Manufacturing with Pb212

4 weeks ago talkbio0Tagged AB001, alpha radioligand therapies, AlphaDirect technology, ARTBIO, Cancer Therapeutic Procedure, Clinical Trials, expansion, Manufacturing, Metastatic castration-resistant prostate cancer, PB212, Series B financing

ARTBIO; Series B financing; alpha radioligand therapies; Pb212; AlphaDirect technology; cancer treatment; manufacturing expansion; AB001; metastatic castration-resistant prostate cancer; clinical trials

Bausch Health to Acquire DURECT and Breakthrough Liver Disease Candidate Larsucosterol for $63M Upfront

4 weeks ago talkbio0Tagged Acquisition, Bausch Health, Breakthrough Therapy, Dosage Forms, DURECT, epigenetic modulator, Hepatitis, Alcoholic, Larsucosterol, Liver diseases, milestone payments, United States Food and Drug Administration

Bausch Health; DURECT; larsucosterol; liver disease; alcoholic hepatitis; epigenetic modulator; FDA Breakthrough Therapy; acquisition; pharmaceutical; milestone payments

AstraZeneca Beats Q2 Estimates on Strong Cancer Drug Sales

4 weeks ago talkbio0Tagged AstraZeneca, Cancer Drug Sales, Enhertu, financial results, Imfinzi, oncology portfolio, Q2 2025, Tagrisso

AstraZeneca; Q2 2025; cancer drug sales; oncology portfolio; Tagrisso; Imfinzi; Enhertu; financial results

Merck & Co. Targets $3B in Cost Savings Through Restructuring, Including Job Cuts

4 weeks ago talkbio0Tagged cost-cutting, Financial savings, Investments, Manufacturing, Merck & Co., R&D, restructuring, restructuring charges, Target

Merck & Co.; cost-cutting; $3 billion savings; restructuring; job cuts; 2027 target; restructuring charges; R&D; manufacturing investments

Novo Nordisk Names Insider Maziar Mike Doustdar as New CEO Amid Growth Challenges

4 weeks ago talkbio0Tagged Appointments, CEO, Drug Industry, drug market, growth outlook, international operations, Leadership Change, Maziar Mike Doustdar, Nordisk, Obesity

Novo Nordisk; Maziar Mike Doustdar; CEO appointment; leadership change; pharmaceutical industry; growth outlook; obesity drug market; international operations