Biomedical Occupation or Discipline – Page 5

Lunit AI Predicts Immunotherapy Outcomes in Colorectal, Kidney, and Lung Cancer at ESMO 2025

2 months ago talkbio0Tagged Biological Markers, Colorectal Carcinoma, Immunotherapy, Lunit AI, Malignant neoplasm of kidney, Malignant neoplasm of lung, Pathology, SCOPE IO, treatment prediction

Lunit AI; SCOPE IO; immunotherapy; colorectal cancer; kidney cancer; lung cancer; biomarkers; ESMO 2025; treatment prediction; AI pathology

Johnson & Johnson to Separate Orthopaedics Business

2 months ago talkbio0Tagged DePuy Synthes, Diastasis, Johnson & Johnson, medtech, Orthopedics

Johnson & Johnson; Orthopaedics; DePuy Synthes; MedTech; Separation

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

2 months ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Ypsomed Invests $248 Million to Establish First U.S. Manufacturing Site in North Carolina

2 months ago talkbio0Tagged CHF, expansion, Facility (object), global growth strategy, Holly Springs, Manufacturing, medical technology, North Carolina, self-injection systems, Surgical construction, United States, Ypsomed

Ypsomed; manufacturing expansion; U.S. facility; Holly Springs; North Carolina; CHF 200 million; self-injection systems; job creation; global growth strategy; medical technology

Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium

2 months ago talkbio0Tagged adjuvant Tecentriq, Clinical Oncology, Clinical Trials, ESMO Congress, Molecular residual disease, muscle-invasive bladder cancer, Natera, Precision Medicine, Presidential Symposium, Signatera

Natera; ESMO Congress; IMvigor011 trial; Presidential Symposium; Signatera; molecular residual disease; muscle-invasive bladder cancer; adjuvant Tecentriq; precision medicine; clinical oncology

NanoPhoria Secures €83.5M Series A for Heart Failure Therapy; AstraZeneca and Algen Ink Up to $555M AI Drug Discovery Pact

2 months ago talkbio0Tagged AI drug discovery, Algen Biotechnologies, AstraZeneca, Clustered Regularly Interspaced Short Palindromic Repeats, Deal Value, gene modulation, Heart failure, Immunology, nano-in-micro delivery, NanoPhoria, NP-MP1, Series A

NanoPhoria; Series A; heart failure; NP-MP1; nano-in-micro delivery; AstraZeneca; Algen Biotechnologies; AI drug discovery; immunology; CRISPR; gene modulation; deal value

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

2 months ago talkbio0Tagged AbbVie, amgen, Application procedure, biology (field), drug applications, funding lapse, Government, J&J, Myers Squibb, Pfizer, pharmaceutical delays, shutdown, United States Food and Drug Administration, user fees

FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer

Ansa Biotechnologies Raises $54.4M in Series B to Scale US DNA Synthesis Manufacturing

2 months ago talkbio0Tagged Ansa Biotechnologies, Biotechnology, Cerberus Ventures, DNA Replication, Manufacturing, Series B financing, synthetic construct, U.S.

Ansa Biotechnologies; Series B financing; DNA synthesis; Cerberus Ventures; US manufacturing; biotechnology; synthetic DNA; fundraising

US Government Shutdown Threatens to Stress an Already Depleted FDA

2 months ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives

2 months ago talkbio0Tagged Approved, Bruton 's tyrosine kinase inhibitor, BTKi, chronic hives, Chronic Spontaneous Urticaria, competition, Immunology, Novartis, Oral Therapy, remibrutinib, Rhapsido, United States Food and Drug Administration

Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition