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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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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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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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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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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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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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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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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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Cerner, Scanwell Health and Personal Genome Diagnostics Acquisition; Zynex’s Fluid Monitoring System, CM-1500; Sight Sciences’ TearCare System; Envista’s Nobel Biocare N1 Implant System

Oracle Corporation sets to acquire Cerner Corporation  On December 20, 2021, Oracle Corporation and Cerner Corporation entered into an agreement as per which Oracle will acquire Cerner through an all-cash tender offer for approximately USD 28.3 billion in equity value.  Larry Ellison, Chairman and C...

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Biogen-Eisai’s Aduhelm; Quidel acquires Ortho Clinical Diagnostics; Accutar Biotechnology’s AC0176; Boehringer’s Spesolimab

Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...

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