Regulation

Pharmaceuticals
Biologics

Canada's CDA-AMC backs conditional reimbursement for Yorvipath

Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
Pharmaceuticals
Biologics
Cell & Gene Therapy

Eledon files IND for islet cell transplant trial as Phase 3 nears

Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
Pharmaceuticals
Biologics

Latigo Biotherapeutics raises $397m IPO to fund non-opioid pain pipeline

The Thousand Oaks biotech floated on Nasdaq in August 2026 and published NEJM data on its lead NaV 1.8 inhibitor onzotrigine in acute pain.
The Thousand Oaks biotech floated on Nasdaq in August 2026 and published NEJM data on its lead NaV 1.8 inhibitor onzotrigine in acute pain.
Pharmaceuticals
Biologics

Newron completes ENIGMA-TRS 1 screening with 12-week data due Q1 2027

Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Medical Devices

ONWARD Medical starts EIGER implant study for spinal cord injury

The Eindhoven neurotechnology company has performed the first ARC-IM implant in its EIGER feasibility study, which will enrol up to 12 participants across subacute
The Eindhoven neurotechnology company has performed the first ARC-IM implant in its EIGER feasibility study, which will enrol up to 12 participants across subacute
Pharmaceuticals
Medical Devices
Diagnostics

PRF Technologies clears IND for OcuRing-K Phase II cataract trial

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
Pharmaceuticals
Genomics

Stoke and Biogen present 4-year zorevunersen data at EEC

Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Medical Devices
Biologics

Tensive gets €20m EIB loan for bioresorbable breast implant

The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
Biologics
Regulatory Science

Vaxcyte hires CMO and CLO as VAX-31 readout moves to October

Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
Pharmaceuticals
Regulatory Science

Inventiva completes patient visits in NATiV3 MASH Phase 3 trial

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Biologics
Pharmaceuticals

Lecanemab subcutaneous autoinjector approved in China for early AD

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
Medical Devices

Nyxoah ACCCESS study hits safety and efficacy endpoints in CCC patients

Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
Pharmaceuticals
Genomics

Ultragenyx Phase 3 Aspire trial fails in Angelman syndrome

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Medical Devices

Medtronic raises FY27 guidance after 13.7% Q1 revenue growth

Medtronic posted Q1 revenue of $9.8bn, beating its own guidance midpoint, and lifted its full-year organic growth outlook to 7.25–7.75%.
Medtronic posted Q1 revenue of $9.8bn, beating its own guidance midpoint, and lifted its full-year organic growth outlook to 7.25–7.75%.
Medical Devices
Diagnostics

Alpha Tau completes 48-patient IMPACT pancreatic cancer enrolment

Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
Pharmaceuticals
Biologics

Boehringer Ingelheim launches SCOVELLA for equine laminitis in GB

Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Diagnostics
Medical Devices
Regulatory Science

Intelligent Bio Solutions hits 98% accuracy ahead of 510(k) filing

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
Diagnostics
Genomics
Pharmaceuticals

Kala Bio signs LOI to distribute Virotek ophthalmic genetic tests

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
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