Notizia - Recent Pharma, Healthcare and Biotech Happenings

MedTech News for Cepheid, Anika, EMVision

THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter

TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System. A wireless robotic handpiece that is part of the TMINI system helps surgeons perform total knee replacements. The TMINI robotic handpiece automatically corrects the surgeon's hand movement to locate bone pins along with precisely defining planes while executing a three-dimensional surgical plan based on a CT scan. TMINI is simple to use and takes the place of many of th...

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Pharma News and Update for Incyte and Aptose

AstraZeneca’s Farxiga; Incyte’s Jakavi; FDA Fast Track Status to HM43239 for R/R AML; Idorsia’s Insomnia Drug Quviviq; EU Approves Kymirah For Follicular Lymphoma; Perrigo Acquires HRA Pharma; Janssen Submits Marketing Authorisation Application to EMA

MedTech News and Updates for GE, Vivalink, and Vektor

GE and Medtronic’s Collaboration; Vivalink’s Multi-Vital Blood Pressure Patch; Foldax’s TRIA Biopolymer Surgical Aortic Heart Valve; Vektor Medical’s vMap Clinical Validation Study; iSono’s ATUS System; Mirvie’s Test to Identify Risk of Preeclampsia

Pharma News and Updates for AstraZeneca, Supernus, and BMS

VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq

Latest MedTech News and Update for MEDIT and Fresenius

MEDIT’s i700 Intraoral Scanner; Phantom Neuro and Blackrock’s Next-Generation Assistive Devices; Fresenius Medical’s Versi PD Cycler System; Franklin Mountain’s Dual Lumen Catheter for Cardiac Applications; Bioretec’s Bioresorbable Implant; Vectorious’s VECTOR-HF II Study

Pharma News and Updates for Coherus, Keymed, Roche, Vicore, Cassiopea

Coherus Biosciences’ Toripalimab; Keymed’s CMG901; Biogen Alzheimer’s Drug Aduhelm; Vicore’s Digital Therapeutics Study; Cassiopea’s Acne Treatment Winlevi; Samsung Biologics Acquires Samsung Bioepis; Roche’s Giredestrant; Ashai Kasei Acquires Bionova

MedTech News and Updates for Penumbra, Axonics, Stimwave, SonoScape

Penumbra’s Indigo System; Axonics’s F15 Recharge-free SNS; Stimwave’s FREEDOM-1 Clinical Trial; Virtual Incision’s MIRA Platform; SonoScape’s HD-550 Endoscopy system; SMART Medical’s G-EYE Colonoscope Series

Pharma News and Updates for GSK, BriaCell, Gilead, Lilly, Merck, Halozyme

GSK Acquires Sierra Oncology; BriaCell’s Targeted Breast Cancer Immunotherapy; Merck’s Tepmetko; Gilead’s Magrolimab for MDS and AML; Eli Lilly’s Retevmo; Merck’s Pneumococcal Vaccine; FDA Approves Bevacizumab Biosimilar; Halozyme to Acquire Antares Pharma

MedTech News for Alcon, I-VASC, Paige, Truvic, and Alucent

Alcon’s Dry Eye Treatment Device; I-VASC Secures Series A Funding; Paige’s AI Medical Device Software; TRUVIC’s Prodigy Thrombectomy System; Alucent’s Natural Vascular Scaffolding Technology; Guardant Presents Data Supporting Efficacy of Blood Test in Detecting Multiple Cancers

Pharma News and Updates BioXcel, Eton, Gilead, Pfizer, Alembic, Telix

BioXcel’s Agitation Drug Igalmi; FDA Approves Cysteine Hydrochloride Injection; Gilead’s Trodelvy; Alembic Pharma’s Topical Anesthetic Cream; Pfizer Acquires ReViral; Telix Buys Lilly’s Failed Cancer Drug Lartruvo

MedTech News Aidoc, Cook Medical, Corvia, Bioventus, GE, Imeka

Aidoc’s Pneumothorax; Cook Medical’s Zenith Thoraco+ Endovascular System; GRAFIX Membrane Study; Corvia’s REDUCE LAP-HF II Trial Results; GE Healthcare and Imeka’s Collaboration; Bioventus to Acquire CartiHeal

Pharma News and Updates Precigen, Biogen, Cerevance, Sanofi, Clovis

Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval

MedTech News for Ypsomed Fresenius Kabi Sientra Synchron HLT

Ypsomed-CamDiab’s Collaboration; Vela Diagnostics’s NGS-Based Pan-Cancer Panels; Fresenius’s SMOFlipid Lipid Injectable Emulsion; Sientra Gained Regulatory Nod to Market Breast Implants; Synchron’s Endovascular BCI Stentrode Device; HLT’s TAVR Clinical Studies

Pharma News and Updates for Sanofi ViiV Argenx Novartis UCB Kyowa

Sanofi’s Rare Disease Drug Xenpozyme’ Approval; FDA Approves Novartis’ Pluvicto; AstraZeneca’s Imfinzi Trial Result; FDA’s Green Signal to Argenx’ Vyvgart; ViiV Healthcare and J&J’s HIV Treatment Cabenuva; UCB’s FINTEPLA Approval; Cullinan’s Update for CLN-081; MEI Pharma & Kyowa’s Zandelisib Approval

MedTech News for Smithfield, Cynosure, bioMérieux, Artio Medical, HeartPoint, ObvioHealth

Smithfield BioScience and BioCircuit’s Nerve Tape Device; Cynosure-Jeisys Medical’s Partnership; bioMérieux’s VITEK® MS PRIME new MALDI-TOF Mass Spectrometry Identification System; Artio Medical’s Gold Embolization Device; Heartpoint Global’s Implant System; ObvioHealth’s Virtual Urogynecology Clinical Trial

Pharma News and Updates for BMS, Biogen, Merck, Moderna, and Takeda

Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor

MedTech News and Updates for NeuroLogica, Cordis, OSF Ventures, Rockley Photonics, Medtronic, NovaSight and Cardiawave

NeuroLogica’s OmniTom Elite; Cordis’s S.M.A.R.T. RADIANZ Vascular Stent System; Rockley Photonics and Medtronic’s Collaboration; NovaSight’s Amblyopia Treatment Device; Cardiawave’s VALVOSOFT; OSF Ventures invests in wireless seizure detection sensor

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter

AstraZeneca’s Farxiga; Incyte’s Jakavi; FDA Fast Track Status to HM43239 for R/R AML; Idorsia’s Insomnia Drug Quviviq; EU Approves Kymirah For Follicular Lymphoma; Perrigo Acquires HRA Pharma; Janssen Submits Marketing Authorisation Application to EMA

GE and Medtronic’s Collaboration; Vivalink’s Multi-Vital Blood Pressure Patch; Foldax’s TRIA Biopolymer Surgical Aortic Heart Valve; Vektor Medical’s vMap Clinical Validation Study; iSono’s ATUS System; Mirvie’s Test to Identify Risk of Preeclampsia

VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq

MEDIT’s i700 Intraoral Scanner; Phantom Neuro and Blackrock’s Next-Generation Assistive Devices; Fresenius Medical’s Versi PD Cycler System; Franklin Mountain’s Dual Lumen Catheter for Cardiac Applications; Bioretec’s Bioresorbable Implant; Vectorious’s VECTOR-HF II Study

Coherus Biosciences’ Toripalimab; Keymed’s CMG901; Biogen Alzheimer’s Drug Aduhelm; Vicore’s Digital Therapeutics Study; Cassiopea’s Acne Treatment Winlevi; Samsung Biologics Acquires Samsung Bioepis; Roche’s Giredestrant; Ashai Kasei Acquires Bionova

Penumbra’s Indigo System; Axonics’s F15 Recharge-free SNS; Stimwave’s FREEDOM-1 Clinical Trial; Virtual Incision’s MIRA Platform; SonoScape’s HD-550 Endoscopy system; SMART Medical’s G-EYE Colonoscope Series

GSK Acquires Sierra Oncology; BriaCell’s Targeted Breast Cancer Immunotherapy; Merck’s Tepmetko; Gilead’s Magrolimab for MDS and AML; Eli Lilly’s Retevmo; Merck’s Pneumococcal Vaccine; FDA Approves Bevacizumab Biosimilar; Halozyme to Acquire Antares Pharma

Alcon’s Dry Eye Treatment Device; I-VASC Secures Series A Funding; Paige’s AI Medical Device Software; TRUVIC’s Prodigy Thrombectomy System; Alucent’s Natural Vascular Scaffolding Technology; Guardant Presents Data Supporting Efficacy of Blood Test in Detecting Multiple Cancers

More Views & Analysis

BioXcel’s Agitation Drug Igalmi; FDA Approves Cysteine Hydrochloride Injection; Gilead’s Trodelvy; Alembic Pharma’s Topical Anesthetic Cream; Pfizer Acquires ReViral; Telix Buys Lilly’s Failed Cancer Drug Lartruvo

Aidoc’s Pneumothorax; Cook Medical’s Zenith Thoraco+ Endovascular System; GRAFIX Membrane Study; Corvia’s REDUCE LAP-HF II Trial Results; GE Healthcare and Imeka’s Collaboration; Bioventus to Acquire CartiHeal

Ypsomed-CamDiab’s Collaboration; Vela Diagnostics’s NGS-Based Pan-Cancer Panels; Fresenius’s SMOFlipid Lipid Injectable Emulsion; Sientra Gained Regulatory Nod to Market Breast Implants; Synchron’s Endovascular BCI Stentrode Device; HLT’s TAVR Clinical Studies

Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor

NeuroLogica’s OmniTom Elite; Cordis’s S.M.A.R.T. RADIANZ Vascular Stent System; Rockley Photonics and Medtronic’s Collaboration; NovaSight’s Amblyopia Treatment Device; Cardiawave’s VALVOSOFT; OSF Ventures invests in wireless seizure detection sensor

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