Month: August 2020

Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA


Excerpt from the Press Release: SAN FRANCISCO & NEW YORK & MELBOURNE, Australia–(BUSINESS WIRE)–Synchron, a neurovascular bioelectronics medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, a fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a…

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Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2


Excerpt from the Press Release: SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today. Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes…

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Karyopharm’s Founder, Sharon Shacham, PhD, Selected as a Finalist for the EY Entrepreneur Of The Year® 2020 Award


Excerpt from the Press Release: NEWTON, Mass., Aug. 21, 2020 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, congratulates its founder, President and Chief Scientific Officer, Sharon Shacham, PhD, MBA, for being selected as a finalist in the EY Entrepreneur of the Year 2020 New England Awards Program. For more…

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This Black Doctors Group Is Making COVID-19 Testing More Accessible


Excerpt from the article: The coronavirus has hit Black communities across the U.S. so hard that the numbers have stopped doctors in their tracks. In Philadelphia, where 42% of the population is Black and 41% is white, Black people are nearly three times more likely than white people to have the coronavirus. An appalling 52% of COVID-19 deaths in…

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Silicon Valley Startup Exo Secures $40M in Series B+ Funding to Advance Handheld Medical Imaging


Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), a pioneering health information and devices company, closed a $40 million Series B+ funding round that will fund research and product development on a revolutionary handheld medical device and cloud-based workflow software platform. Medical imaging technology has lagged far behind the needs of today’s…

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ForDoz Pharma partners with Lupin on development of 2 complex injectable products


Excerpt from the Press Release: EAST WINDSOR, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) — ForDoz Pharma has entered into an agreement with Lupin, to market and distribute 2 complex injectable products in advanced development stage at ForDoz, in US and its territories. The products are in the Oncology and Anti-infective therapeutic areas which when approved,…

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Kaiser to launch Phase 3 testing of coronavirus vaccine in 1,400 California and Oregon adults


Excerpt from the Press Release: Kaiser Permanente has joined a Phase 3 clinical trial to test a coronavirus vaccine candidate currently in production by Pfizer and BioNTech, and will seek to enroll 1,400 adults aged 18-85 in California and Oregon to join in the study, a press release from the medical organization states. The aim…

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Ask Us Anything – Pharmacovigilance


This is our second meeting in our ongoing series titled “Ask us Anything – in Clincal Trials”. In this meeting we were fortunate to host our guests from JSS Research and their Pharmacovigilance team. We had a great time discussing the importance of Pharmacovigilance within the clinical trial process. If you’d like to catch the…

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Quidel’s Lyra® Direct SARS-CoV-2 Assay Receives Health Canada Authorization


Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Quidel Corporation (NASDAQ: QDEL) (“Quidel”),a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Health Canada authorization to market and sell the Lyra® Direct SARS-CoV-2 Assay in Canada. (IO315563, COVID-19 Medical Device Authorization for Importation or Sale; 07/20/2020)…

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Children’s Hospital of Philadelphia President and CEO Releases Special COVID-19 Podcast Series


Excerpt from the Article: PHILADELPHIA, Aug. 13, 2020 /PRNewswire/ — When the COVID-19 pandemic began earlier this year, doctors and researchers at Children’s Hospital of Philadelphia (CHOP) rapidly pivoted to focus on defeating the novel virus. Across the hospital, members of the CHOP team – from infectious disease researchers to population health experts – mobilized…

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