Biomedical Occupation or Discipline – Page 4

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

1 month ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

RAPT Therapeutics Announces Proposed Public Offering of Common Stock

1 month ago talkbio0Tagged Biological Factors, conditions, Dilution technique, Gross (qualifier value), Immunology, Market, Pricing, public entity, RAPT

RAPT Therapeutics; public offering; common stock; underwritten offering; biopharmaceutical; immunology; market conditions; share dilution; offering pricing; gross proceeds

Alector’s GSK-partnered dementia drug latozinemab fails in late-stage trial

1 month ago talkbio0Tagged Alector, Clinical trial failure, Drug Development, Latozinemab, Phase 3 trial, Pick Disease of the Brain, Presenile dementia, Progranulins, SmithKline Beecham

Alector; GSK; latozinemab; dementia; frontotemporal dementia; Phase 3 trial; clinical trial failure; progranulin; drug development

Neuphoria Scraps Social Anxiety Drug After Trial Failure; Minerva Doubles Down on Schizophrenia Therapy

1 month ago talkbio0Tagged AFFIRM-1 phase 3 trial, BNC210, Clinical trial failure, Discontinuation (procedure), Merck, Neuphoria, Neuroscience discipline, Partnership, Phobia, Social, Post-Traumatic Stress Disorder, Programs - Publication Format, Schizophrenia

Neuphoria Therapeutics; BNC210; social anxiety disorder; AFFIRM-1 phase 3 trial; clinical trial failure; program discontinuation; PTSD; Merck partnership; Minerva Neurosciences; schizophrenia therapy

Diorasis Therapeutics Welcomes Dr. Dimitri Azar to Its Board of Directors

1 month ago talkbio0Tagged Biotechnology, board of directors, Clinical Development, Dimitri Azar, Diorasis, gene therapy, Glaucoma, Ophthalmology specialty, United States Food and Drug Administration

Diorasis Therapeutics; Dimitri Azar; Board of Directors; gene therapy; glaucoma; ophthalmology; biotechnology; FDA; clinical development

Connecticut Biotech Veradermics Secures $150M for Phase 3 Trials of Oral Rogaine

1 month ago talkbio0Tagged Biotechnology, Clinical Development, Clinical Trials, Connecticut biotech, Fund Raising, hair loss treatment, Oral cavity, Phase 3, Rogaine, Veradermics

Veradermics; Connecticut biotech; oral Rogaine; Phase 3 clinical trials; fundraising; hair loss treatment; biotechnology; clinical development

Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

2 months ago talkbio0Tagged Biological Science Disciplines, Canal Row Advisors, innovation, Leadership, Michael Rogers, Policy, public health medicine (field), reform, regulatory consulting, regulatory strategy, United States Food and Drug Administration

Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy

Gene Therapy Delivers Long-Term Immune Protection in Children With Rare Immune Disorders

2 months ago talkbio0Tagged Adenosine deaminase deficiency, Clinical Trials, Combined immunodeficiency disease, Congenital leukocyte adherence deficiency, Curative Therapy, gene therapy, immune protection, Leukocyte adhesion deficiency type 1, Long-term, Pediatric immunology, Rare Diseases, Severe (severity modifier)

gene therapy; long-term immune protection; ADA-SCID; severe combined immunodeficiency; LAD-I; leukocyte adhesion deficiency; rare disease; pediatric immunology; clinical trial; curative treatment

Former FDA Deputy Dr. Namandjé N. Bumpus to Lead Charles River’s New Scientific Advisory Board

2 months ago talkbio0Tagged alternative testing, Animal Welfare, biopharmaceutical innovation, Charles River Laboratories, Drug Development, Namandjé Bumpus, NAMs, New Approach Methodologies, Scientific Advisory Board, United States Food and Drug Administration

Namandjé Bumpus; Charles River Laboratories; Scientific Advisory Board; FDA; New Approach Methodologies; NAMs; alternative testing; drug development; animal welfare; biopharmaceutical innovation

Pelage Pharmaceuticals Raises $120M to Advance Hair Loss Regenerative Therapy to Phase 3 Trials

2 months ago talkbio0Tagged Alopecia, Androgenetic Alopecia, Pelage, Phase 3 clinical trial, PP405, Regenerative Medicine, Series B financing, Stem Cell Therapy

Pelage Pharmaceuticals; hair loss; regenerative medicine; PP405; Phase 3 clinical trial; Series B financing; stem cell therapy; androgenetic alopecia