July 2025 – Page 11

Veru Survey Highlights Muscle Loss Concerns Among GLP-1 Users as Lean Mass-Preserving Drug Advances

4 months ago talkbio0Tagged agonists, Diet, High-Protein, Elderly (population group), enobosarm, GLP-1 receptor, Lean Mass, muscle loss, Obesity, Surveys, Veru

Veru; GLP-1 receptor agonists; muscle loss; enobosarm; lean mass; obesity; survey; older adults; high-protein diet

Sino Biopharm Acquires Merck’s PD-1xVEGF Bispecific Partner LaNova for up to $951M

4 months ago talkbio0Tagged Acquisition, Antibodies, Bispecific, Biopharm, Cancer Therapeutic Procedure, isononanoyl oxybenzene sulfonate, LaNova Medicines, Merck, PD-1xVEGF

Sino Biopharm; LaNova Medicines; acquisition; Merck; PD-1xVEGF bispecific antibody; cancer therapy; Chinese pharma; $951 million deal

Advancements in Predicting Tumor Response and Expanding Therapy Eligibility Using Epigenomic Biomarkers

5 months ago talkbio0Tagged Biological Markers, Diagnostics, DNA Methylation, Epigenomics, personalized cancer therapy, Prediction, tumor response

epigenomic biomarkers; tumor response prediction; personalized cancer therapy; DNA methylation; AI-driven diagnostics

FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin

5 months ago talkbio0Tagged Drug Approval, fee structure, Mediation, PDUFA VIII, regulatory policy, United States Food and Drug Administration, user fees

FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations

LEO Pharma Acquires Exclusive Global Rights for Boehringer Ingelheim’s Psoriasis Drug Spevigo in €90 Million Deal

5 months ago talkbio0Tagged Boehringer Ingelheim, Drug licensing, Generalized pustular psoriasis, IL1RAP protein, human, Immunology, News [Publication Type], Partnership, Pharma, Psoriasis, spesolimab, Spevigo

LEO Pharma; Boehringer Ingelheim; Spevigo; spesolimab; psoriasis; GPP; drug licensing; immunology; IL-36 receptor; partnership; biotech news

Viome and Scripps Initiate AI-Powered At-Home RNA Test for Early Colon Cancer Risk Detection

5 months ago talkbio0Tagged AI-powered diagnostics, at-home colon cancer, Cancer Detection, Clinical Research, Colonic Polyps, Microbiome, RNA test, Screening for cancer, Scripps Research, Viome

Viome; Scripps Research; AI-powered diagnostics; RNA test; at-home colon cancer screening; colon polyps; clinical study; microbiome; early cancer detection

Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings

5 months ago talkbio0Tagged Clinical Trials, File (record), Narcolepsy, Narcolepsy type 1, orexin agonist, oveporexton, Phase 3 Clinical Trials, Takeda, United States Food and Drug Administration

Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results

WHO to Develop Guidelines for Gilead’s Twice-Yearly HIV PrEP Injection (Lenacapavir)

5 months ago talkbio0Tagged Approved, Gilead, Guidelines, HIV Prevention, Lenacapavir, PREP gene, twice-yearly injection, United States Food and Drug Administration, World Health Organization

WHO; Gilead; Lenacapavir; twice-yearly injection; PrEP; HIV prevention; guidelines; FDA approval

GSK’s ViiV Expands Licensing Deal to Increase Access to Long-Acting Injectable HIV Treatment

5 months ago talkbio0Tagged cabotegravir, Environmental pool, generic manufacturing, Global Health, HIV, licensing agreement, SmithKline Beecham, ViiV Healthcare

GSK; ViiV Healthcare; long-acting HIV treatment; cabotegravir; licensing agreement; Medicines Patent Pool; generic manufacturing; HIV; global health

FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues

5 months ago talkbio0Tagged Approved, gene therapy, manufacturing issues, Mucopolysaccharidosis Type IIIA, Regulatory Setback, Response Letter, Ultragenyx, United States Food and Drug Administration, UX111

FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay