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Following Discussion with the FDA, Karyopharm Plans to Initiate a New Placebo-Controlled Randomized Study of Selinexor in the Advanced or Recurrent Endometrial Cancer p53 Wild-Type Population to Support a Future sNDA Submission as the Current Topline Data from the SIENDO Study are Unlikely to Support an sNDA Approval Karyopharm is Encouraged by the SIENDO p53…
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Excerpt from the Press Release: REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in the U.S. have successfully completed first cases with its new…
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Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a collaboration and co-marketing partnership with Jumpcode Genomics that validates Jumpcode’s CRISPRclean technology on Element’s AVITI System. The partnership has already demonstrated the value of pairing the technologies, promising improved data quality and cost…
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Excerpt from the Press Release: BEIJING, SHANGHAI and BOSTON, Feb. 23, 2022 /PRNewswire/ — Jacobio Pharmaceuticals (1167.HK) announced that its KRAS G12C inhibitor JAB-21822 completed the first patient dosing in combination therapy with Cetuximab at Peking University Cancer Hospital recently. JAB-21822 in combination with cetuximab for the treatment of KRAS G12C-mutated advanced colorectal cancer. Colorectal cancer is the second most common tumor…
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CMS establishes new Level II HCPCS code for Prescription Digital Behavioral Therapy, FDA Cleared, per Course of Treatment to describe prescription digital therapeutics (PDTs) including Pear’s PDTs for the treatment of substance use disorder (reSET®), opioid use disorder (reSET-O®), and chronic insomnia (Somryst®), respectively The new code marks an important access and reimbursement milestone for providers, payers,…
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– Roche continues to increase access to accurate, timely and reliable diagnostics in the fight against COVID-19 by expanding the COVID-19 PCR portfolio on the cobas 5800 System – These tests are for the qualitative detection of SARS-CoV-2 and the qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus – As…
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A recent study found that Viz ANEURYSM had a 94 percent accuracy rate of diagnosing subarachnoid hemorrhages on computed tomography angiography (CTA). Excerpt from the Press Release: Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the…
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Ability to serially monitor treatment response, identify key biomarkers and customize assay aids clinical research efforts to improve treatment for metastatic cancers involving brain and spinal cord Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Feb. 22, 2022– Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, highlighted the ability of its CNSide™ cerebrospinal…
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— Company Expects to Announce Topline Results from the Phase 1/2 Study by the End of 2022 — — Proof-of-Concept Study Will Evaluate the Safety, Tolerability and Immunogenicity of VAX-24 — — VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine Designed to Deliver Broad-Spectrum Protection — Excerpt from the Press Release: SAN CARLOS, Calif., Feb. 23, 2022…
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Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than…
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