News & Updates
Excerpt from the Press Release: SOLANA BEACH, Calif., March 02, 2022 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, announced that the Company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for…
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Dexcom CGM to be evaluated for performance in the hospital and for the potential of more effective glycemic management and improved patient outcomes in the hospital setting Breakthrough Device Designation from the FDA is a critical milestone for in-patient Dexcom CGM use This designation provides a more efficient and streamlined review pathway so innovative Dexcom…
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Dragonfly receives a milestone payment from Bristol Myers Squibb for progression of its Phase 1 DF6002-001 study with a PK profile and peripheral PD consistent with preclinical models Excerpt from the Press Release: WALTHAM, Mass., March 1, 2022 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly”) today announced the achievement of a Phase 1 clinical development milestone for the…
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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: SUNNYVALE, Calif., March 01, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to…
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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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–Final data and potential for $25m milestone anticipated in H1 2023– Excerpt from the Press Release: SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today announced the completion of enrollment in the Phase 2 HERA clinical study…
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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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