Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by Occlutech’s Flex II PFO Occluder to the…

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17 ส.ค. 64

MedAlliance announces Completion of Enrolment in PRISTINE Clinical Trial with SELUTION SLR™ Sirolimus Drug Eluting Balloon

MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded “Breakthrough Device Designation” by the FDA. PRISTINE is a Prospective Registry to Investigate the Safety and efficacy of Treatment with SELUTION SLR Sirolimus […]

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13 ส.ค. 64

Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

Single booster dose at 6 months of NVX-CoV2373 increased wild-type neutralizing antibodies more than 4-fold versus primary vaccination series Six-fold increase in cross-reactive functional antibodies to Delta variant compared to primary vaccination series Analysis of sera from primary vaccination series also showed cross-reactive functional antibodies to Alpha, Beta and Delta variants, all of which increased […]

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6 ส.ค. 64

Novavax and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax’ Recombinant Nanoparticle COVID-19 Vaccine

– Novavax and Serum Institute of India file regulatory submissions to the Drugs Controller General of India and to regulatory agencies in Indonesia and Philippines for Novavax’ recombinant nanoparticle COVID-19 vaccine – Filing for World Health Organization Emergency Use Listing expected in August 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for […]

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6 ส.ค. 64

CartiHeal Announces Pivotal Study Results Demonstrate Agili-C™ Superiority to Microfracture and Debridement for the Treatment of Cartilage and Osteochondral Defects

According to a Two-Year Randomized and Controlled Multinational IDE Study CartiHeal Ltd, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, which was granted Breakthrough Device Designation by the FDA last year, announced today two-year results of the pivotal IDE Study. The Agili-C™ clinical study was conducted […]

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4 ส.ค. 64

GenScript Joins Forces with Allozymes by Providing Smart Libraries Construction for Precision Protein Engineering

GenScript Biotech Corporation (Stock Code: 1548.HK) today announced a collaboration with Allozymes, a synthetic biology company transforming ingredient manufacturing by unlocking protein engineering potential through groundbreaking technologies. In this partnership, GenScript will provide the mutant libraries construction to Allozymes for their downstream applications across various industries including pharmaceuticals, cosmetics and food &…

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3 ส.ค. 64

Glenmark inks agreement with Canadian biotech SaNOtize to commercialize Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets

Nitric oxide has antimicrobial properties with direct proven effect on SARS-CoV-2 Nitric Oxide Nasal Spray (NONS) has been tested in healthy volunteers and patients as part of UK and Canada clinical trials1 Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company and Canadian biotech firm SaNOtize Research & Development Corp. today announced an exclusive long term […]

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3 ส.ค. 64

Highlights From The Alzheimer’s Association International Conference 2021

Research presented at the Alzheimer’s Association International Conference® (AAIC®) 2021 suggests COVID-19 is associated with long-term cognitive dysfunction and acceleration of Alzheimer’s disease pathology and symptoms. These studies were among several pieces of groundbreaking research featured at AAIC 2021. “These new data point to disturbing trends showing COVID-19 infections leading to lasting cognitive impairment and even…

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30 ก.ค. 64

EDM Council Report Uncovers Major Evolution in Data Management Practices within Pharma / Life Sciences

Latest benchmark report from EDMC, OSTHUS, PwC Strategy& includes intel from 7 of top 10 Pharma companies globally EDM Council, the cross-industry trade association for data management and analytics, along with OSTHUS and Strategy&, PwC’s global strategy consulting business, have released the 2021 EDM Council Global Data Management Benchmark Survey for the Pharma / Life […]

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30 ก.ค. 64
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