expansion – Talk Bio

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

3 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

No Recent News on BetterHelp’s Quiet AI Expansion; Focus Remains on Insurance Growth

5 days ago talkbio0Tagged Acquisition, BetterHelp, expansion, Insurance, mental health, Revenue Decline, Teladoc

Teladoc; BetterHelp; insurance expansion; UpLift acquisition; mental health; revenue decline

FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

1 month ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

2 months ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

AstraZeneca Onshores Rare Disease Portfolio as Part of $50B US Investment Pledge

2 months ago talkbio0Tagged AstraZeneca, expansion, Infrequent, Investments, Maryland (geographic location), onshoring, pledge, portfolio, R&D, U.S., Virginia facility

AstraZeneca; rare disease portfolio; onshoring; US investment; biomanufacturing; $50 billion pledge; Virginia facility; Maryland investment; R&D expansion

Pfizer Reduces Stake in BioNTech; Candel Pauses Pancreatic Cancer Program

2 months ago talkbio0Tagged Acquisition, BioNTech, Comirnaty, expansion, Metsera, mRNA Vaccine, Pancreatic carcinoma, Pfizer, pipeline

Pfizer; BioNTech; stake reduction; Candel Therapeutics; pancreatic cancer; Comirnaty; mRNA vaccine; Metsera acquisition; pipeline expansion

Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease

3 months ago talkbio0Tagged Alzheimer 's disease, at-home injection, dosing, Eisai, expansion, Labels (device), Leqembi, Maintenance, sBLA, starting dose, status - In progress, Subcutaneous Autoinjector, supplemental biologics, United States Food and Drug Administration

Eisai; Leqembi; subcutaneous autoinjector; label expansion; Supplemental Biologics License Application (sBLA); FDA; maintenance dosing; starting dose; early Alzheimer’s disease; at-home injection; launch progress

Oura Health’s Healthcare Ambitions Materialize with $11 Billion Valuation and Expansion Plans

3 months ago talkbio0Tagged expansion, Generalized, Healthcare technology, Oura, Oura Ring, personalized health services, Preventive Health Services, Series E funding, valuation, wearables market

Oura; Oura Ring; healthcare technology; Series E funding; $11B valuation; AI health features; wearables market; global expansion; preventive health; personalized health services

Lilly Commits $1.2 Billion to Expand GLP-1 Pill Manufacturing Facility in Puerto Rico

3 months ago talkbio0Tagged Carolina, eli lilly, expansion, Investments, Manufacturing, Oral Medicine, orforglipron, pharmaceutical production, Product containing glucagon-like peptide 1 receptor agonist (product), Puerto Rico, supply chain, United States

Eli Lilly; Puerto Rico; GLP-1 receptor agonist; orforglipron; manufacturing expansion; oral medicines; investment; Carolina; pharmaceutical production; U.S. supply chain