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TEZSPIRE (tezepelumab) Approved in the US for Severe Asthma
12/17/2021
AstraZeneca and Amgen’s TEZSPIRE (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
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KAHR to Host Key Opinion Leader Webinar on the Potential of CD47 Therapeutics for the Treatment of Solid Tumor and Hematologic Malignancies
11/23/2021
KAHR, a cancer immunotherapy company developing novel multifunctional immune-recruitment proteins, today announced it will host a virtual key opinion leader (KOL) webinar on the potential of CD47 therapeutics for the treatment of solid tumor and hematologic malignancies on Thursday, December 2, 2021, from 4:30 pm to 5:30 pm ET.
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Clinical Catch-Up: October 11-15
10/18/2021
It was yet another busy week for clinical trial announcements. Take a look. -
Ascendis Pharma A/S Announces U.S. Commercial Launch of SKYTROFA® (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for Pediatric Growth Hormone Deficiency
10/15/2021
Ascendis Pharma A/S (Nasdaq: ASND), today announced the U.S. commercial launch of SKYTROFA (lonapegsomatropin-tcgd), its once-weekly treatment for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
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Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting
10/9/2021
Adverum Biotechnologies, Inc. is presenting data from the INFINITY clinical trial of ADVM-022 in patients with diabetic macular edema during the American Society of Retina Specialists 39th Annual Scientific Meeting and will be presenting an encore presentation of long-term data from the OPTIC trial of ADVM-022 for wet AMD on Monday, October 11, 2021 at 8:50 am CT.
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Amunix Presents Preclinical Data on Its XPAT T Cell Engager Platform at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics
10/7/2021
Amunix Pharmaceuticals, Inc. (Amunix), today announced that preclinical data from its lead program, AMX-818 (HER2-XPAT), were presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics.
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RIBOMIC Announces Presentation of Masked Preliminary Interim Data from Phase 2 Trials of RBM-007 for Wet Age-Related Macular Degeneration at the Retina Society 2021 Meeting
9/30/2021
RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics (TOKYO:4591), today announced the presentation of preliminary interim results from the ongoing two Phase 2 studies, TOFU and the RAMEN extension study in patients with Wet Age-Related Macular Degeneration (wAMD) by Dr. Raj Maturi at the 54th Annual Scientific Meeting of the Retina Society, Chicago, USA.
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Candel Therapeutics Completes Enrollment in Phase 3 Clinical Trial of CAN-2409 in Combination with Valacyclovir for the Treatment of Intermediate-High Risk Localized Prostate Cancer
9/7/2021
Candel Therapeutics, Inc. (“Candel”) (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that it has completed patient enrollment for its pivotal phase 3 study of CAN-2409 immunotherapy in patients with intermediate-high risk localized prostate cancer.
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Glaukos Announces Submission of Supplemental Pre-Market Approval Application for iStent infinite™
9/3/2021
Glaukos Corporation (NYSE: GKOS), today announced that it has submitted a supplemental pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the iStent infinite™ Trabecular Micro-Bypass System.
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KAHR Announces FDA Clearance of IND Application for Phase 1b Trial of its Lead Anti-CD47 Candidate in Blood Cancers
9/2/2021
KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for KAHR's Phase 1b clinical trial of DSP107, a first-in-class CD47x41BB targeting fusion protein, in acute myeloid leukemia and myelodysplastic syndrome.
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ImmunoGenesis Announces Positive Preclinical Glioblastoma and Pancreatic Cancer Data for STimulator of INterferon Genes (STING) Agonist Published in Two Scientific Journals
8/31/2021
ImmunoGenesis Inc.,announces the publication of positive data for its STimulator of INterferon Genes (STING) agonist in the treatment of canines with previously diagnosed glioblastoma (GBM), the second most common type of canine brain cancer that shares very close similarities to its human counterpart, in Clinical Cancer Research, a journal of the American Association for Cancer Research.
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Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency
8/25/2021
Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, today announced that the U.S. Food and Drug Administration (FDA) has approved SKYTROFA
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Just as it was beginning to appear safe to return to maskless, pre-pandemic life, the Delta variant of the SARS-CoV-2 virus emerged. It is fast-spreading, more likely to lead to hospitalizations, and accounts for most of the breakout infections among fully vaccinated individuals.
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While modern-day science has provided the world with highly effective vaccines to fight the COVID-19 pandemic, researchers have had less luck finding effective treatment options for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).
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Adverum Provides Update on ADVM-022 and the INFINITY Trial in Patients with Diabetic Macular Edema
7/22/2021
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today provided an update on the ADVM-022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema (DME) and the OPTIC clinical trial in patients with wet age-related macular degeneration (wet AMD)
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American Diabetes Association Presents Latest COVID-19 Findings With Five Comprehensive Panel Symposia At The 81st Scientific Sessions
6/24/2021
The American Diabetes Association® (ADA) is kicking off the virtual 81st Scientific Sessions tomorrow and will feature five COVID-19 Symposia, highlighting cutting-edge science and the latest diabetes developments learned during the initial phases of the pandemic.
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Amunix Appoints Industry Veteran, Frank Watanabe, to its Board of Directors
6/23/2021
Amunix Pharmaceuticals, Inc. announced that it has expanded its board of directors with the appointment of Frank Watanabe, CEO of Arcutis and a biopharmaceutical executive with extensive leadership, strategy, operations and financing experience.
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KAHR Announces $46.5 Million Financing to Advance its Multifunctional Immunotherapeutic Pipeline
6/16/2021
KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, announced the first closing of an investment round raising $46.5 million.
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Samsung Biologics and KAHR Medical Announce Development and Manufacturing Agreement for Cancer Immunotherapy Drug Candidate
6/2/2021
Samsung Biologics, the world's leading contract development and manufacturing organization, signed a strategic partnership with KAHR Medical Ltd., a cancer immunotherapy company developing novel multifunctional immune-recruitment proteins.