Biomedical Occupation or Discipline

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

21 hours 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

23 hours 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

1 week 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 weeks 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 weeks 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 weeks 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 weeks 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

AnaptysBio Announces Strategic Business Split to Create Two Public Companies, Sharpening Asset Focus

2 weeks ago talkbio0Tagged AnaptysBio, asset, biopharmaceutical development, business split, Immunology, Imsidolimab, Jemperli, public companies, restructuring, royalty management

AnaptysBio; business split; royalty management; biopharmaceutical development; Jemperli; imsidolimab; public companies; immunology treatments; asset value; restructuring

Novo Nordisk Terminates $598M Heart Failure Cell Therapy Collaboration with Heartseed Amid Major Restructuring

2 weeks ago talkbio0Tagged Biotechnology, Cardiospermum grandiflorum, Cell Therapy, Collaboration termination, Diabetes, Heart failure, HS-001, Maziar Mike Doustdar, Nordisk, Obesity, strategic restructuring

Novo Nordisk; Heartseed; heart failure; cell therapy; HS-001; collaboration termination; strategic restructuring; Maziar Mike Doustdar; diabetes; obesity; biotechnology

Sanofi Injects $625M Into Biotech Investment Arm to Accelerate Innovation

3 weeks ago talkbio0Tagged Cash, cell/gene therapy, digital health, expansion, Immunology, Infrequent, Infusion procedures, Investments, Neurology speciality, portfolio, sanofi, Sanofi Ventures, venture capital

Sanofi; Sanofi Ventures; biotech investment; $625M cash infusion; digital health; immunology; rare diseases; neurology; venture capital; cell/gene therapy; portfolio expansion