Temporal Concept – Page 8

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

4 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Merus Phase 2 Data: Analysts See Strong Survival in Head & Neck Cancer, ‘Home Run’ Hopes Emerge

4 months ago talkbio0Tagged Cancer of Neck, Clinical Trials, Head, Keytruda, Merus, Overall Survival, pembrolizumab, Petosemtamab, Phase 2, Reaction, scenario

Merus; petosemtamab; Phase 2; overall survival; head and neck cancer; Pembrolizumab; Keytruda; clinical trial; analyst reaction; home run scenario

Exit Strategy: Biopharma Professionals Consider Opportunities Outside Industry and US

4 months ago talkbio0Tagged Biological Science Disciplines, Biopharma, biopharma survey, biotech careers, Drug Industry, employment, Industry, Market, Transition Mutation, trends qualifier, U.S.

biopharma talent; job market trends; industry transition; employment outside US; biopharma survey 2025; life sciences employment; biotech careers; pharmaceutical industry

Spotlight on LGBTQ+ Leaders Driving Change in Life Sciences

4 months ago talkbio0Tagged Biological Science Disciplines, Biopharma, Diversity, Fellows, GUTC, Health Workforce, Inclusion, Leadership, LGBTQ+ professionals, Monthly (qualifier value), philanthropy

LGBTQ+ professionals; life sciences; biopharma; leadership; Diversity and Inclusion; Health Workforce; GUTC Fellows; philanthropy; Pride Month

Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection

4 months ago talkbio0Tagged Aldose Reductase Inhibitor, Apply, Cautionary Warning, Classical galactosemia, clinical trial conduct, Govorestat, Infrequent, Rejection, United States Food and Drug Administration

Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter

BioMarin Acquires Inozyme Pharma for $270M, Gaining Phase 3 Rare Disease Therapy

4 months ago talkbio0Tagged Acquisition, BioMarin, Deficiency, ENPP1 gene, Enzyme Replacement Therapy, Infrequent, Inozyme, INZ-701, Pharma, Phase 3 clinical trial

BioMarin; Inozyme Pharma; acquisition; rare disease; INZ-701; ENPP1 Deficiency; enzyme replacement therapy; Phase 3 clinical trial

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

4 months ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease

Sanofi Commits $20 Billion to US Expansion Amid Industry-Wide Investment Surge

4 months ago talkbio0Tagged drug production, Industry, Investments, pharmaceutical manufacturing, R&D, sanofi, supply chain, Surgical construction, trends qualifier, U.S.

Sanofi; US investment; pharmaceutical manufacturing; R&D; drug production; job creation; supply chain; industry trends

Merck’s Keytruda Achieves Industry-First Success in Preventing Head and Neck Cancer Recurrence: AACR 2025 Highlights

4 months ago talkbio0Tagged AACR, Cancer of Neck, Clinical Trials, Event-Free Survival, Head, KEYNOTE-689 trial, Keytruda, locally advanced head, Merck, pembrolizumab, perioperative, recurrence prevention, Squamous cell carcinoma, United States Food and Drug Administration

Keytruda; Merck; AACR 2025; head and neck cancer; resectable locally advanced head and neck squamous cell carcinoma; event-free survival; KEYNOTE-689 trial; perioperative pembrolizumab; recurrence prevention; clinical trial; FDA

Azafaros Raises €132M in Series B to Fund Phase 3 Trials for Brain-Penetrant Drug

4 months ago talkbio0Tagged Azafaros, Brain-Penetrant Drug, Capital, Clinical Trials, Forbion, Growth, Jeito, Lysosomal Storage Diseases, neuro-metabolic diseases, Neurodegenerative Disorders, nizubaglustat, Phase 3, Series B funding

Azafaros; Series B funding; nizubaglustat; brain-penetrant drug; lysosomal storage disorders; rare neuro-metabolic diseases; phase 3 clinical trials; Jeito Capital; Forbion Growth; neurodegenerative diseases