LOC – Talk Bio

Hua Medicine Advances Dorzagliatin Expansion Beyond China with Hong Kong NDA Acceptance

2 days ago talkbio0Tagged Asia, Southeastern, China, diabetes drug, dorzagliatin, expansion, glucokinase activator, Hong Kong NDA, Hua Medicine

Hua Medicine; dorzagliatin; diabetes drug; China expansion; Hong Kong NDA; Southeast Asia; glucokinase activator

MoonLake revives FDA push; biotech trio to debut in Hong Kong

2 weeks ago talkbio0Tagged * * Investor Day, Asia, Biological Factors, Blackfoot language, Capital, Hidradenitis Suppurativa, Hong Kong, HS drug approval pathway, immunotherapeutics, License Application, Market, MIRA trial, MoonLake, sonelokimab, Type B meeting, United States Food and Drug Administration, VELA-1 trial, VELA-2 trial

MoonLake Immunotherapeutics; Sonelokimab; Hidradenitis Suppurativa; FDA Type B meeting; Biologics License Application; BLA H2 2026; VELA-1 trial; VELA-2 trial; MIRA trial; HS drug approval pathway; investor day February 23 2026; Hong Kong biotech IPOs; Hong Kong listing; Asia biotech capital markets

US Commits $480-487 Million in Health Funding to Ivory Coast Under ‘America First’ Health Strategy

3 weeks ago talkbio0Tagged Americas, COAST, deals, Funding, global health security, Health, HIV, Ivory, Malaria, Tuberculosis, U.S.

US Ivory Coast health agreement; America First health deals; $487 million funding; HIV malaria tuberculosis; global health security

Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations

1 month ago talkbio0Tagged compounding pharmacy, East Windsor facility, Empower Pharmacy, Facility (object), Glucagon-Like Peptide 1, Inspection (procedure), layoffs, manufacturing shutdown, New Jersey operations, Outsourcing, Qualitative form, United States Food and Drug Administration, Workforce reduction

Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction

Wave Life Sciences RNA obesity shot shows fat loss with muscle preservation but trails Eli Lilly’s candidates

2 months ago talkbio0Tagged Adangme language, eli lilly, fat loss, INHBE, Injection of therapeutic agent, muscle preservation, Obesity, RNA obesity, Scientific Sessions, Wave Life Sciences, WVE-007

Wave Life Sciences; WVE-007; INHBE; RNA obesity drug; obesity shot; fat loss; muscle preservation; Eli Lilly; ADA Scientific Sessions

Biocon Biologics Secures Market Entry Date for Denosumab Biosimilars in Europe and Global Markets

2 months ago talkbio0Tagged Amgen settlement, Biocon Biologics, Biosimilars, biosimilars approval, bone health, Commission, denosumab, entry - ActRelationshipCheckpoint, Europe market, European (ethnic group), Evfraxy, Neoplasms, Vevzuo

Biocon Biologics; Denosumab biosimilars; Vevzuo; Evfraxy; Europe market entry; Amgen settlement; biosimilars approval; European Commission; bone health; oncology

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

2 months ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

BMS Jettisons Coronary Trial for J&J-Partnered Anticoagulant

2 months ago talkbio0Tagged Anticoagulants, BMS-986177, Clinical Trial Termination, coronary trial, Factor XIa inhibitor, Janssen, Myers Squibb

Bristol Myers Squibb; Johnson & Johnson; Janssen; anticoagulant; Factor XIa inhibitor; BMS-986177; coronary trial; clinical trial termination

FluoGuide Strengthens Leadership to Drive Clinical and Regulatory Advancements

3 months ago talkbio0Tagged board of directors, Camilla Harder Hartvig, Changing, Chief Operating Officer, Clinical Development, Donna Haire, FluoGuide, Leadership, precision cancer, regulatory approval

FluoGuide; leadership changes; Donna Haire; Chief Operating Officer; Camilla Harder Hartvig; Board of Directors; FG001; clinical development; regulatory approval; precision cancer surgery

Otsuka Acquires Asia-Pacific Rights to 4D Molecular Therapeutics’ Retinal Gene Therapy 4D-150 for $85 Million

3 months ago talkbio0Tagged 4D Molecular Therapeutics ', Asia-Pacific, gene therapy, Macular edema due to diabetes mellitus, Ophthalmology specialty, Otsuka, strategic partnership, Wet Age-Related Macular Degeneration

Otsuka; 4D Molecular Therapeutics; 4D-150; Asia-Pacific rights; gene therapy; wet age-related macular degeneration; diabetic macular edema; $85 million; strategic partnership; ophthalmology