Notizia - Recent Pharma, Healthcare and Biotech Happenings

medtech-news-for-organogenesis-livanova-hyperfine

FDA Grants Approval to Caris Life Sciences for MI Cancer Seek; Johnson & Johnson MedTech Secures FDA IDE Approval for OTTAVA; Organogenesis Shares Positive Interim Data from Second Phase 3 Study of ReNu; LivaNova’s OSPREY Trial Achieves Key Safety and Efficacy Milestones; Hyperfine Launches Advanced Portable MR Brain Imaging Swoop® System Across Europe; Nihon Kohden Strengthens Neurological Solutions Through Ad-Tech Medical Instrument Corporation Acquisition

Caris Life Sciences Received FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test On November 6, 2024, Caris Life Sciences, a leading next-generation AI TechBio company and precision medicine pioneer, announced that the U.S. Food and Drug Administration (FDA) approved MI Cancer Seek™ for use as a companion diagnostic (CDx) to identify cancer patients who might benefit from treatment with targeted therapies. The assay included one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek became the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based as...

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medtech-news-for-cordis-forma-medical-virpax

Cordis FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device; Forma Medical’s Optimal Plating System FDA Approval; Virpax’s Swine Model Pilot Study Positive Results; SetPoint Medical Positive Topline Results from Pioneering RESET-RA Study; Signature Orthopaedics Partnered with THINK Surgical; Nusano and PharmaLogic Formed Strategic Supply Agreement

pharma-news-for-eli-lilly-ideaya-roche-sanofi

Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

medtech-news-for-artivion-masimo-icecure

Artivion and Endospan Agreement; Masimo and Cleveland Clinic Collaboration; Academic Medical Center’s Sedation-Free TNE With the EvoEndo Endoscopy System; IceCure’s Next-Gen XSenseTM Cryoablation System FDA Approval; KORU Medical Systems’ Clearance for FreedomEdge® Infusion System; Reflow Medical’s First Patient in Coronary Sirolimus-Eluting Retrievable Scaffold System

pharma-news-for-eisai-merck-verona-astrazeneca

Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR EU CHMP Recommendation; Verona Pharma’s Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

medtech-news-for-alcon-globus-medical-ricoh-esaote

Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

pharma-news-for-alnylam-bms-daichii-sankyo-vertex

Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

medtech-news-for-boston-scientific-corporation-philips-akili-roche

Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

pharma-news-for-takeda-astrazeneca-johnson-and-johnson-bms

Takeda Showcase Phase III Results for Soticlestat; Imfinzi and Chemotherapy Combination Gains US Approval; Nipocalimab Shows Notable Efficacy in Phase II Study; Bristol Myers Squibb’s Augtyro FDA Approval; AstraZeneca’s Farxiga FDA Approval

medtech-news-for-asensus-surgical-allosource-abbott-foldax

Asensus Surgical Acquired by Karl Storz; Allosource® Launched Aceconnex®; Siemens Healthineers FDA Clearance for Chiller-Free Biograph Trinion PET/CT; Abbott Received FDA Clearance; Foldax® Reported Positive Clinical Results; Amber Implants Completed Enrolment of First-In-Human Clinical Trial

pharma-news-for-moderna-almirall-lilly-ipsen

Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval

medtech-news-for-stryker-qiagen-evolution-optiks-nexalin

Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics

pharma-news-for-moderna-scemblix-kite-astellas

Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso

medtech-news-for-nikon-teijin-spineart-ceretrieve

Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

pharma-news-for-astrazeneca-biogen-altrubio-gsk

AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation

medtech-news-for-laborie-carestream-implicity-angiodynamics

Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial

Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR EU CHMP Recommendation; Verona Pharma’s Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

Takeda Showcase Phase III Results for Soticlestat; Imfinzi and Chemotherapy Combination Gains US Approval; Nipocalimab Shows Notable Efficacy in Phase II Study; Bristol Myers Squibb’s Augtyro FDA Approval; AstraZeneca’s Farxiga FDA Approval

More Views & Analysis

Asensus Surgical Acquired by Karl Storz; Allosource® Launched Aceconnex®; Siemens Healthineers FDA Clearance for Chiller-Free Biograph Trinion PET/CT; Abbott Received FDA Clearance; Foldax® Reported Positive Clinical Results; Amber Implants Completed Enrolment of First-In-Human Clinical Trial

Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval

Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso

Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation

Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status

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