Business, energy, technology, markets and global industry news from Business News Today
Pharma & Biotech

Orphalan starts Phase 3 once-daily trientine trial against D-penicillamine in Wilson disease

Orphalan has launched the global Phase 3 TRADITiONAL study comparing an investigational once-daily trientine tetrahydrochloride formulation with D-penicillamine over 48 weeks.

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Pharma & Biotech

Efti gets a new development path as Immutep investigates manufacturing link to Phase III setback

Immutep finds manufacturing differences after TACTI-004 and refocuses efti on head and neck cancer and sarcoma. See what comes next.

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Medical Devices & Diagnostics

FDA clears expanded LUMA Vision VERAFEYE platform for real-time cardiac mapping and catheter guidance

LUMA Vision has secured additional FDA clearance for VERAFEYE, integrating real-time 2D and 3D cardiac anatomy, catheter tracking and procedural guidance ahead of a planned 2027 U.S. launch.

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Pharma & Biotech

FDA clears Alebund AP308 IND for first-in-human IgA nephropathy study

The FDA has cleared Alebund Pharmaceuticals’ AP308 IND, allowing a first-in-human study of an engineered IgA protease designed to remove pathogenic IgA and immune complexes in IgA nephropathy.

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Pharma & Biotech

Only about 40% of extensive-stage SCLC patients reach second-line therapy. Amgen and AstraZeneca are moving Imdelltra earlier

Amgen’s Phase 3 DeLLphi-305 trial met its primary overall survival endpoint with Imdelltra plus Imfinzi as first-line maintenance in extensive-stage small cell lung cancer.

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Pharma & Biotech

FDA accepts Nanoscope MOGENRY BLA for gene-agnostic treatment of severe retinitis pigmentosa

The FDA has accepted Nanoscope Therapeutics’ BLA for MOGENRY, an optogenetic therapy designed to restore useful vision in severe retinitis pigmentosa regardless of the underlying mutation.

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Medical Devices & Diagnostics

Corcym implants first TriMemo tricuspid ring. Can surgical repair keep pace with transcatheter therapy?

Cleveland Clinic has completed the first human implantation of Corcym’s TriMemo annuloplasty ring, moving a purpose-built Nitinol platform into tricuspid repair as cardiac surgery faces growing competition from transcatheter structural-heart therapies.

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Medical Devices & Diagnostics

Abbott wins FDA approval for dual-energy TactiFlex Duo. Does AFib ablation need two tools in one?

Abbott’s TactiFlex Duo combines pulsed field ablation and radiofrequency energy in one contact-force catheter, giving electrophysiologists a way to move between tissue-selective PFA and conventional thermal ablation without changing platforms during an AFib procedure.

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Pharma & Biotech

Bristol Myers Squibb’s arlo-cel clears pivotal myeloma endpoints after BCMA therapy

Arlocabtagene autoleucel met response and complete-response endpoints in patients already exposed to immunomodulators, proteasome inhibitors, anti-CD38 treatment and BCMA therapy, positioning GPRC5D as a possible next CAR T target after increasingly crowded myeloma treatment sequences.

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Pharma & Biotech

Pharvaris cuts HAE attacks 83% with oral deucrictibant XR. Can it challenge injections?

Once-daily deucrictibant XR reduced hereditary angioedema attacks by 83% across the Phase 3 CHAPTER-3 population, giving Pharvaris a potential oral prophylaxis product alongside its separately developed immediate-release rescue formulation.

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