News & Updates

Profound Medical Receives FDA HDE Approval for Sonalleve®

12/01/2020

Excerpt from the Press Release: TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX: PRN) (“Profound” or the “Company”) announced today that Sonalleve® has received U.S. Food and Drug Administration (“FDA”) approval under a Humanitarian Device Exemption (“HDE”) for the treatment of osteoid osteoma. Osteoid osteoma is a non-cancerous bone tumor that…

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Celltrion concludes enrolment in global Covid-19 antibody trial

12/01/2020

Excerpt from the Press Release: Celltrion Group has completed enrolment of 327 patients with mild-to-moderate SARS-CoV-2 infection symptoms to evaluate anti-Covid-19 monoclonal antibody treatment candidate CT-P59 in the global Phase II clinical trial. Celltrion Group has completed enrolment of 327 patients with mild-to-moderate SARS-CoV-2 infection symptoms to evaluate anti-Covid-19 monoclonal antibody treatment candidate CT-P59 in…

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Envisioning a Transformed Clinical Trials Enterprise for 2030 – Session 3

11/30/2020

March 24, 2021 @ 11:00 am – 3:00 pm EDT The National Academies’ Forum on Drug Discovery, Development, and Translation will host a virtual public workshop on Mar 24, 2021 as part of a web series forum of events to discuss critical policy for advancement of biopharmaceutical innovation nationally and globally. This virtual public workshop…

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Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for Neuro-Oncology Annual Meeting

11/27/2020

Excerpt from the Press Release: BOSTON, Nov. 19, 2020 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) today announced the presentation of new clinical data from three ongoing trials of Ad-RTS-hIL-12 plus veledimex (Controlled IL-12) for the treatment of recurrent glioblastoma (rGBM) and diffuse intrinsic pontine glioma (DIPG) at the 2020 Society…

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Adagio Therapeutics COVID-19 Antibody Demonstrates Best-in-Class Breadth and Potency Against a Range of Coronaviruses that Pose Human Threat

11/26/2020

Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Adagio Therapeutics, Inc., today pre-published in vitro and in vivo data demonstrating its lead antibody candidate, ADG2, shows similar or higher potency against SARS-CoV-2 compared to monoclonal antibodies (mAbs) in clinical development, while also uniquely offering broad neutralization against a range of sarbecoviruses that pose a threat to…

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Tough yet flexible: Biologically inspired adhesive may improve fetal surgery

11/25/2020

Excerpt from the Article: In children with spina bifida, the neural tube that forms the spinal cord and brain doesn’t close during early prenatal development. That leaves the nerves of the spinal cord exposed to potential damage from fetal movement and the surrounding amniotic fluid. While surgeons can repair spina bifida soon after birth, the…

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Mammography AI Tool Cleared This Year Improves Breast Cancer Detection

11/25/2020

Excerpt from the Article: Adding artificial intelligence (AI) to mammography interpretation can help radiologists catch more cancers, according to a new study using a tool awarded U.S. Food & Drug Administration 510(k) clearance earlier this year. Currently, the body of literature around the effectiveness of AI with mammography is small because the use of the…

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Fluidigm COVID-19 Community Connect Program Builds a Network of Testing Partners to Increase Access of Saliva-Based SARS-CoV-2 Testing for Communities

11/25/2020

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced COVID-19 Community Connect, a program to link federal, state and local governmental entities, public health agencies, academic institutions, workforces, individuals and…

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BioMarin and Deep Genomics to Collaborate on Advancing Programs Identified Using Artificial Intelligence

11/24/2020

Excerpt from the Press Release: SAN RAFAEL, Calif. and TORONTO, Nov. 17, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) and Deep Genomics today announced that the companies have entered into a preclinical collaboration that will use Deep Genomics’ artificial intelligence drug discovery platform (The AI Workbench) to identify oligonucleotide drug candidates in four rare disease indications…

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The FDA’s Digital Health Center Of Excellence: Why It Matters And What It Means To You

11/23/2020

Excerpt from the Article: Last month, the US Food and Drug Administration (FDA) launched the Digital Health Center of Excellence (DHCoE), bolstering the shift toward digital that the healthcare industry has already been embracing. Investment in digital health is at an all-time high. The market cap created from nine IPOs in 2019 from companies in…

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