Notizia - Recent Pharma, Healthcare and Biotech Happenings

MedTech News GI Dynamics, EndoStream Medical, Ibex, Sunrise

GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite

First Patient Enrolled in I-STEP Clinical Study of EndoBarrier in India On February 13, 2023, GI Dynamics Inc., a medical device company, announced the enrollment of the first candidate in the I-STEP clinical trial in India. The trial aimed to assess the safety and effectiveness of the EndoBarrier® System for glycaemic improvement in patients with type 2 diabetes and obesity that is not effectively controlled. I-STEP is a multi-centered, randomized, controlled, pivotal trial of the EndoBarrier® System in India. Around 100 candidates are expected to enroll in the trial and throughout the 24-month research period, patients treated with EndoBarrier will recei...

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Alcon to acquire Ivantis; Philips to takeover Cardiologs; Flunked cancer drug progresses in I-O in pancreatic cancer models; Indigo system CAT RX catheter meets primary endpoint in trial

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Smith+Nephew’s LEGION CONCELOC; Renew Bioscience’s Cerezen; Perimeter Medical’s ATLAS AI Project; SAGA Diagnostics-AZ’s Deal; Magnus Receives Breakthrough Device Designation; ReValve’s Transeptal Mitral Valve Replacement

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Magnus Medical’s tech gets breakthrough status; Prolacta develops tests for pathogens detection; Renovia gets breakthrough designation for leva system; Hinge Health secures $600M funding

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FDA 510k clearance to Naviswiss’s Naviplan; FDA approved to TYRVAYA; Centinel Spine’s STALIF Integrated Interbody System; Smith+Nephew’s IODOSORB; AlloSource’s AlloMend Extra-Large ADM; SpinaFX and StarFish’s strategic commercialisation contract

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Ocular Therapeutix’s insert fails in phase 2; Click Therapeutics raises $52M funding; Roche introduces AVENIO Tumour Tissue CGP Kit; Blue Wolf Capital to acquire CIVCO Radiotherapy

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Hologic to acquire Bolder Surgical; Breakthrough Device Designation to Biological Dynamics; Luminopia declares FDA approval; HistoSonics secures Breakthrough Device Designation; Phillips-Medisize expands worldwide; PolyNovo launches NovoSorb BTM tech

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Biogen’s ALS drug Tofersen (BIIB067); Phathom’s erosive esophagitis drug trial; Vertex’s islet cell therapy; Natera launches lung DNA test

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Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;

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Brickell to Submit New Drug Application to FDA; Twin Health Raises $140M; BMS’ Deucravacitinib; Lando Biopharma’s LABP-104 gets Approval; NIH Grant of $ 3 M to Amydis; FDA Grant to GenSight’ GS030

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Amber Implants VCFix spinal system; iotaMotion’s iotaSOFT Insertion System; Boston Scientific acquires Baylis; ReCor’s Paradise Ultrasound Renal Denervation; Boston Scientific’s Ranger Drug-Coated Balloon; Natera’s Prospera

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Pfizer tightens DMD trial criteria over safety concerns; Kytopen raises $30M; Eli Lilly taps Reify’s Care Access; Vensana Capital raises $325M

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RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval

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UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

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Boston Scientific pays $336M; Boehringer Ingelheim acquires Abexxa Biologics; Oncology, RNA biotech 858 Therapeutics inks $60M Series A; Novartis acquires Arctos Medical

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Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain

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FDA’s New Drug Application to ALS Drug; Approval to BeiGene’s Brukinsa; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite

Alcon to acquire Ivantis; Philips to takeover Cardiologs; Flunked cancer drug progresses in I-O in pancreatic cancer models; Indigo system CAT RX catheter meets primary endpoint in trial

Smith+Nephew’s LEGION CONCELOC; Renew Bioscience’s Cerezen; Perimeter Medical’s ATLAS AI Project; SAGA Diagnostics-AZ’s Deal; Magnus Receives Breakthrough Device Designation; ReValve’s Transeptal Mitral Valve Replacement

Magnus Medical’s tech gets breakthrough status; Prolacta develops tests for pathogens detection; Renovia gets breakthrough designation for leva system; Hinge Health secures $600M funding

FDA 510k clearance to Naviswiss’s Naviplan; FDA approved to TYRVAYA; Centinel Spine’s STALIF Integrated Interbody System; Smith+Nephew’s IODOSORB; AlloSource’s AlloMend Extra-Large ADM; SpinaFX and StarFish’s strategic commercialisation contract

Ocular Therapeutix’s insert fails in phase 2; Click Therapeutics raises $52M funding; Roche introduces AVENIO Tumour Tissue CGP Kit; Blue Wolf Capital to acquire CIVCO Radiotherapy

Hologic to acquire Bolder Surgical; Breakthrough Device Designation to Biological Dynamics; Luminopia declares FDA approval; HistoSonics secures Breakthrough Device Designation; Phillips-Medisize expands worldwide; PolyNovo launches NovoSorb BTM tech

Biogen’s ALS drug Tofersen (BIIB067); Phathom’s erosive esophagitis drug trial; Vertex’s islet cell therapy; Natera launches lung DNA test

Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;

More Views & Analysis

Brickell to Submit New Drug Application to FDA; Twin Health Raises $140M; BMS’ Deucravacitinib; Lando Biopharma’s LABP-104 gets Approval; NIH Grant of $ 3 M to Amydis; FDA Grant to GenSight’ GS030

Amber Implants VCFix spinal system; iotaMotion’s iotaSOFT Insertion System; Boston Scientific acquires Baylis; ReCor’s Paradise Ultrasound Renal Denervation; Boston Scientific’s Ranger Drug-Coated Balloon; Natera’s Prospera

Pfizer tightens DMD trial criteria over safety concerns; Kytopen raises $30M; Eli Lilly taps Reify’s Care Access; Vensana Capital raises $325M

RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval

UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

Boston Scientific pays $336M; Boehringer Ingelheim acquires Abexxa Biologics; Oncology, RNA biotech 858 Therapeutics inks $60M Series A; Novartis acquires Arctos Medical

Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain

FDA’s New Drug Application to ALS Drug; Approval to BeiGene’s Brukinsa; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises

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