Medical Device – Talk Bio

Halozyme to Acquire Elektrofi for $750 Million, Expanding Drug Delivery Capabilities

1 week ago talkbio0Tagged Acquisition, Biological Factors, Drug Delivery Systems, Elektrofi, Halozyme, Hypercon, microparticle technology, milestone payments, subcutaneous delivery

Halozyme Therapeutics; Elektrofi; acquisition; drug delivery; Hypercon; biologics; subcutaneous delivery; milestone payments; microparticle technology; Q4 2025

Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries

2 weeks ago talkbio0Tagged Evaluation, Manufacturing, Medical Devices, medtech industry, National Security, pharmaceutical imports, Sectioning technique, semiconductor tariffs, supply chain, tariffs, Transplant Registry Unified Management Program

Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices

Acadia Halts Development of Nasal Prader-Willi Drug After Phase 3 Failure

2 weeks ago talkbio0Tagged Acadia, carbetocin, Clinical trial failure, Compass, Hyperphagia, Nasal Spray, Prader-Willi Syndrome

Acadia Pharmaceuticals; carbetocin; Prader-Willi syndrome; Phase 3 trial; COMPASS PWS study; clinical trial failure; nasal spray; hyperphagia

J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

1 month ago talkbio0Tagged Approved, BCG-Unresponsive, Carcinoma, Drug Delivery Systems, gemcitabine intravesical system, in situ, Inlexzo, Johnson & Johnson, Malignant neoplasm of urinary bladder, New, Non-Muscle Invasive Bladder Neoplasms, SunRISe-1 trial, United States Food and Drug Administration

Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

1 month ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

2 months ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

Teva Execs Shrug Off Pharmaceutical Tariff Threat as Turnaround Strategy Rolls Forward

2 months ago talkbio0Tagged earnings, Francis, Growth, operating profit margin, pharmaceutical tariffs, Pivot Device, Richard, supply chain, tariff threat, Teva, turnaround strategy

Teva; tariff threat; pharmaceutical tariffs; turnaround strategy; supply chain; pivot to growth; earnings; innovative medicines; Richard Francis; operating profit margin

Tourmaline Bio’s Heart Drug Pacibekitug Shows Promise Against Cardiovascular Inflammation, Targets Competition with Novo, CSL

5 months ago talkbio0Tagged Cardiovascular system, heart drug, Inflammation, interleukin-6, Markers (device), Nordisk, pacibekitug, Phase 2 trial, SMPX gene, tourmaline, United States Food and Drug Administration

Tourmaline Bio; heart drug; pacibekitug; cardiovascular inflammation; inflammation markers; Novo Nordisk; CSL; Phase 2 trial; FDA; IL-6

Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost

5 months ago talkbio0Tagged Adoption, Alzheimer 's disease, Approved, AutoInjector, Biogen, dosing, Eisai, Hematologic Tests, launch, Leqembi, Maintenance, Market, subcutaneous, United States Food and Drug Administration

Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption

Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis

5 months ago talkbio0Tagged Approved, DTC Campaign, Empowerment, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, self-administration, Syringes, United States Food and Drug Administration, Vyvgart Hytrulo

Vyvgart Hytrulo, prefilled syringe, FDA approval, self-administration, generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), DTC campaign, patient empowerment