news
Feb 08, 2022
Biogen’s Aduhelm; FDA Approves Sanofi’s Enjaymo; NHS & Orchard Signs a Deal; Bristol’s Breyanzi & Abecma; Pharming’s Leniolisib; Eli Lilly’s Verzenio Trial; UCB’ Zilucoplan Trials Result; Eli Lilly’s Alzheimer’s Drug Donanemab
Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...
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Feb 03, 2022
Insulet’s Omnipod 5 Automated Insulin Delivery System; Alivecor’s KardiaMobile Card; BD Board Approved the Spinoff of embecta; Medtronic’s Hugo Surgery Robot; Artivion’s On-X® Mitral Heart Valve PROACT; OmnySense’s Smart Thermometer Clinical Trial
Insulet Received FDA Clearance for its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control On January 28, 2022, Insulet Corporation, a market leader in developing tubeless insulin pumps with its product, Omnipod®, received the FDA approval for its Omnipod® 5 Automated Insu...
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Feb 01, 2022
Immunocore’s Kimmtrak; Samsung Acquires Biogen’s Biosimilar Unit; Novavax’s COVID-19 Vaccine; CHMP Approves Dupixent (dupilumab); Glenmark’s High Blood Pressure Treatment; Roche’s Faricimab; GBT’s Voxelotor
Immunocore Receives FDA Approval for the First Uveal Melanoma Treatment, As Well As the First T-cell Receptor Therapeutics Uveal Melanoma, an aggressive eye cancer, has proven to be a tough nut to crack for researchers seeking a cure. However, with the approval of a new treatment, those with the disorder will ha...
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Jan 27, 2022
Fluidx Medical’s GPX Embolic Device; Cardiovascular Systems & OrbusNeich’s Scoreflex Scoring Balloon; BENDIT’s BENDIT21 Neuro Catheter; Cook Medical Drug-eluting Stent; Zimmer Biomet’s Spinoff; Smith+Nephew’s PICO 7 and PICO 14 System
GPX Embolic Device Success in Challenging Tumor Case On January 20, 2022, In a multi-center clinical study, Fluidx Medical's GPX Embolic Device was utilized to efficiently devascularize a massive tumor with several feeding vessels. The GPX Embolic Device is a cutting-edge embolic device that allows for easy prep...
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Jan 25, 2022
Merck’s Gefapixant; Pfizer’s Somatrogon; Gilead’s Viklury; AbbVie’s Skyrizi; Gilead’s Zydelig Approvals; Lantern’s LP-184; Polpharma to Acquire Advent
Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, rela...
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Jan 20, 2022
Suneva Medical-Viveon Health merger update; Smith+Nephew acquires Engage Surgical; Abiomed’s preCARDIA technology; Medtronic’s DTM Spinal Cord Stimulation; Endo Tools Therapeutics’s Endomina System; Diadem’s AlzoSure predict prognostic blood test
Suneva Medical Inc. inked a merger agreement with Viveon Health On January 12, 2022, Suneva Medical Inc., a leading regenerative aesthetics company, and Viveon Health Acquisition Corp., a particular purpose acquisition company, entered into a definitive merger agreement to establish a new regenerative aesthetics...
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Jan 18, 2022
Algernon’s NP-120 (ifenprodil); Pieris’s cinrebafusp alfa (PRS-343) clinical trial; Gaumard Scientific’s multidisciplinary patient simulator HAL S5301; Hekka Labs’s decentralized healthcare ecosystem
Algernon receives positive FDA feedback on Phase IIb chronic cough trial The US Food and Drug Administration (FDA) has given positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) for chronic cough treatment. A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenp...
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Jan 11, 2022
Noxxon’s NOX-A12 clinical trial; Exact Sciences buys PreventionGenetics; Nuvalent’s clinical trails for NVL-520; Stryker acquires Vocera Communications
Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...
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Jan 06, 2022
Siemens Healthineers’s COVID-19 Antigen Self-Test; Paragon’s R3ACT Stabilization System; Pulnovo Medical’s PADN-CFDA trial; Endotronix’s PROACTIVE-HF trial; Abbott’s Proclaim XR SCS System; RTI Surgical spins off businesses
Siemens Healthineers received Emergency Use Authorization for CLINITEST® Rapid COVID-19 Antigen Self-Test by the FDA On December 29, 2021, Siemens Healthineers was granted Emergency Use Authorization (EUA) for its CLINITEST Rapid COVID-19 Antigen Self-Test by the United States Food and Drug Administration ...
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Jan 04, 2022
Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys
FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...
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