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STAFF - BIOWORLD
Holland Johnson is the managing editor of BioWorld MedTech. He has more than 15 years of editorial and reporting experience, including the last 12 years in the newsletter industry covering medical technology, home health care and clinical advances in oncology and women's health. Prior to that, Johnson was a beat reporter for theAthens Observer.
NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. IN THE CLINIC FOR MAY 19, 2021 Company Product Description Indication Status Phase I Biomarin Pharmaceutical Inc., of San Rafael Valoctocogene roxaparvovec Gene therapy expressing Factor VIII Hemophilia A In the phase I/II study, after 5 years and 4 years of follow-up of the 6e13 vg/kg and 4e13 vg/kg cohorts, respectively, all participants in both cohorts remain off prophylactic factor VIII treatment; mean annualized bleed OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the OTHER NEWS TO NOTE FOR MAY 12, 2021 Other news to note for May 12, 2021. Atyr Pharma Inc., of San Diego, and its Hong Kong subsidiary, Pangu Biopharma Ltd., together with the Hong Kong University of Science and Technology (HKUST), said they have achieved the milestones set forth for the first year of a $750,000 grant received from the Hong Kong Government’s Innovation and UV LIGHT, RESPIRATORY CATHETER FOR COVID-19 FROM CEDARS Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV MDR COMPLIANCE PERIOD KICKS OFF WITH SWISS MISS ON MUTUAL The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse. WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer.STAFF - BIOWORLD
Holland Johnson is the managing editor of BioWorld MedTech. He has more than 15 years of editorial and reporting experience, including the last 12 years in the newsletter industry covering medical technology, home health care and clinical advances in oncology and women's health. Prior to that, Johnson was a beat reporter for theAthens Observer.
NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. IN THE CLINIC FOR MAY 19, 2021 Company Product Description Indication Status Phase I Biomarin Pharmaceutical Inc., of San Rafael Valoctocogene roxaparvovec Gene therapy expressing Factor VIII Hemophilia A In the phase I/II study, after 5 years and 4 years of follow-up of the 6e13 vg/kg and 4e13 vg/kg cohorts, respectively, all participants in both cohorts remain off prophylactic factor VIII treatment; mean annualized bleed OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the OTHER NEWS TO NOTE FOR MAY 12, 2021 Other news to note for May 12, 2021. Atyr Pharma Inc., of San Diego, and its Hong Kong subsidiary, Pangu Biopharma Ltd., together with the Hong Kong University of Science and Technology (HKUST), said they have achieved the milestones set forth for the first year of a $750,000 grant received from the Hong Kong Government’s Innovation and UV LIGHT, RESPIRATORY CATHETER FOR COVID-19 FROM CEDARS Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV MDR COMPLIANCE PERIOD KICKS OFF WITH SWISS MISS ON MUTUAL The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse. WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer. NOVAVAX’S COVID-19 VACCINE SHOWS 100% PROTECTION AGAINST Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains. SINGLE DOSE OF PFIZER VACCINE NOT STRONG ENOUGH AGAINST LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. A single dose of the vaccine also is not effective against the South Africa variant B.1.351, and most likely BIOWORLD. LINK TO HOMEPAGE. Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation, business, financing, regulation, science, product development, clinical trials and more OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of INCREASING NUMBER OF BIOPHARMA DRUGS TARGET COVID-19 AS One day earlier, San Francisco-based Vir Biotechnology Inc. signed a global development collaboration with Wuxi Biologics, of Shanghai, to produce human monoclonal antibodies to treat COVID-19. According to the World Health Organization, China has reported nearly 80,000 cases and more than 2,700 deaths. OTHER NEWS TO NOTE FOR MAY 12, 2021 Other news to note for May 12, 2021. Atyr Pharma Inc., of San Diego, and its Hong Kong subsidiary, Pangu Biopharma Ltd., together with the Hong Kong University of Science and Technology (HKUST), said they have achieved the milestones set forth for the first year of a $750,000 grant received from the Hong Kong Government’s Innovation and ITEMS TAGGED WITH 'COGNITIVE IMPAIRMENT' Researchers have demonstrated that enhancing myelin renewal in the brains of transgenic APP/PS1 mouse models of Alzheimer's disease (AD) can improve their task-related hippocampal activity SOMMETRICS SEEKS EUA FOR SLEEP AID TO REDUCE COVID-19 Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy. MEDTRONIC UNVEILS VIRTUAL GUIDE FOR SPINAL CORD Medtronic plc has launched Careguidepro, its first patient-focused digital tool for spinal cord stimulation. The mobile app and online portal enables providers to better manage patients’ pain relief with real-time feedback and data. Developed in partnership with Higgs Boson Health, the app and web-based platform serves as a virtual guide for patients navigating their spinal cord stimulation BIOWORLD: THE DAILY BIOPHARMACEUTICAL AND MEDICALBIOWORLDBIOWORLD MEDTECHBIOWORLD ASIABIOWORLD SCIENCEDATA SNAPSHOTSSPECIAL REPORTS COVID-19 R&D drives sector’s research spending in Q1. The top 100 public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, spent a total of almost $12 billion on R&D in More in BioWorld Asia. SINGLE DOSE OF PFIZER VACCINE NOT STRONG ENOUGH AGAINST LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. A single dose of the vaccine also is not effective against the South Africa variant B.1.351, and most likely DELAYING SECOND COVID-19 VACCINE DOSE INCREASES ANTIBODY LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium. Extending the second dose interval to 12 weeks increased the peak SARS NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. IN THE CLINIC FOR MAY 19, 2021 Company Product Description Indication Status Phase I Biomarin Pharmaceutical Inc., of San Rafael Valoctocogene roxaparvovec Gene therapy expressing Factor VIII Hemophilia A In the phase I/II study, after 5 years and 4 years of follow-up of the 6e13 vg/kg and 4e13 vg/kg cohorts, respectively, all participants in both cohorts remain off prophylactic factor VIII treatment; mean annualized bleed U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the FDA REVEALS DEPTH OF MANUFACTURING ISSUES AT EMERGENT FDA reveals depth of manufacturing issues at Emergent Biosolutions. In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson (J&J) is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer. MDR COMPLIANCE PERIOD KICKS OFF WITH SWISS MISS ON MUTUAL The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse. BIOWORLD: THE DAILY BIOPHARMACEUTICAL AND MEDICALBIOWORLDBIOWORLD MEDTECHBIOWORLD ASIABIOWORLD SCIENCEDATA SNAPSHOTSSPECIAL REPORTS COVID-19 R&D drives sector’s research spending in Q1. The top 100 public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, spent a total of almost $12 billion on R&D in More in BioWorld Asia. SINGLE DOSE OF PFIZER VACCINE NOT STRONG ENOUGH AGAINST LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. A single dose of the vaccine also is not effective against the South Africa variant B.1.351, and most likely DELAYING SECOND COVID-19 VACCINE DOSE INCREASES ANTIBODY LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium. Extending the second dose interval to 12 weeks increased the peak SARS NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. IN THE CLINIC FOR MAY 19, 2021 Company Product Description Indication Status Phase I Biomarin Pharmaceutical Inc., of San Rafael Valoctocogene roxaparvovec Gene therapy expressing Factor VIII Hemophilia A In the phase I/II study, after 5 years and 4 years of follow-up of the 6e13 vg/kg and 4e13 vg/kg cohorts, respectively, all participants in both cohorts remain off prophylactic factor VIII treatment; mean annualized bleed U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the FDA REVEALS DEPTH OF MANUFACTURING ISSUES AT EMERGENT FDA reveals depth of manufacturing issues at Emergent Biosolutions. In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson (J&J) is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer. MDR COMPLIANCE PERIOD KICKS OFF WITH SWISS MISS ON MUTUAL The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse. NOVAVAX’S COVID-19 VACCINE SHOWS 100% PROTECTION AGAINST Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains. CHINA‘S CNBG/SINOPHARM COVID-19 VACCINE IS 79% EFFECTIVE HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Volunteers who received the vaccine in the phase III experiment produced high-tier antibodies, with a neutralizing antibody positive conversion rate of 99.52% after two doses, the company said. U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of BIOWORLD. LINK TO HOMEPAGE. Breaking news and analysis of the global biotechnology, pharmaceutical, medical device and medical technology sectors. In-depth coverage of innovation, business, financing, regulation, science, product development, clinical trials and more UV LIGHT, RESPIRATORY CATHETER FOR COVID-19 FROM CEDARS Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV NO LAG FOR IOVANCE IN MELANOMA RACE; VERDICT PENDING TIL Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology (ASCO) turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy. FDA REVEALS DEPTH OF MANUFACTURING ISSUES AT EMERGENT In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson (J&J) is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. That approval could be awhile in coming. On April 21, a day after completing its onsite inspection of Emergent’s Bayview plant ITEMS TAGGED WITH 'COGNITIVE IMPAIRMENT' Researchers have demonstrated that enhancing myelin renewal in the brains of transgenic APP/PS1 mouse models of Alzheimer's disease (AD) can improve their task-related hippocampal activity TARGETING SENESCENT CELLS RESTORES KIDNEY FUNCTION Targeting senescent cells restores kidney function. Researchers at the Center for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh reported in the May 19, 2021, issue of Science Translational Medicine that the Bcl2/w/xL targeting senolytic compound, ABT-263 ( navitoclax) could reverse the age-related fibrosis YISHENG UNVEILS PIKA ADJUVANTED RECOMBINANT PROTEIN BEIJING – One more company is joining the global efforts in developing a vaccine for COVID-19. Beijing-based Yisheng Biopharma Co. Ltd. unveiled YS-SC2-010, which was developed through recombinant protein technology and its proprietary PIKA (polyinosinic-polycytidylic acid-based adjuvant) technology. The company is looking to take it overseas through partnership. NOVAVAX’S COVID-19 VACCINE SHOWS 100% PROTECTION AGAINSTAUTHOR: LEELANDENBERGER
Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains. SINGLE DOSE OF PFIZER VACCINE NOT STRONG ENOUGH AGAINST LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. A single dose of the vaccine also is not effective against the South Africa variant B.1.351, and most likely NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc.STAFF - BIOWORLD
Holland Johnson is the managing editor of BioWorld MedTech. He has more than 15 years of editorial and reporting experience, including the last 12 years in the newsletter industry covering medical technology, home health care and clinical advances in oncology and women's health. Prior to that, Johnson was a beat reporter for theAthens Observer.
OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York DELAYING SECOND COVID-19 VACCINE DOSE INCREASES ANTIBODY LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium. Extending the second dose interval to 12 weeks increased the peak SARS NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of UV LIGHT, RESPIRATORY CATHETER FOR COVID-19 FROM CEDARS Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer. NOVAVAX’S COVID-19 VACCINE SHOWS 100% PROTECTION AGAINSTAUTHOR: LEELANDENBERGER
Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains. SINGLE DOSE OF PFIZER VACCINE NOT STRONG ENOUGH AGAINST LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. A single dose of the vaccine also is not effective against the South Africa variant B.1.351, and most likely NEXT UP, NOVAVAX, AFTER APRIL’S VACCINE WOES AND Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc.STAFF - BIOWORLD
Holland Johnson is the managing editor of BioWorld MedTech. He has more than 15 years of editorial and reporting experience, including the last 12 years in the newsletter industry covering medical technology, home health care and clinical advances in oncology and women's health. Prior to that, Johnson was a beat reporter for theAthens Observer.
OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York DELAYING SECOND COVID-19 VACCINE DOSE INCREASES ANTIBODY LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium. Extending the second dose interval to 12 weeks increased the peak SARS NOVAVAX NOW PUSHES ANTICIPATED EUA FILING FROM JUNE TO THE Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the U.K.’S MIX-AND-MATCH TRIAL TO TEST SEVEN VACCINES FOR LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of UV LIGHT, RESPIRATORY CATHETER FOR COVID-19 FROM CEDARS Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV WAVEGUIDE DEBUTS PORTABLE NMR DEVICE Waveguide debuts portable NMR device. Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer. NOVAVAX’S COVID-19 VACCINE SHOWS 100% PROTECTION AGAINST Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains. OTHER NEWS TO NOTE FOR MAY 20, 2021 Other news to note for May 20, 2021. Plainview, N.Y.-based Acupath Laboratories Inc. reported its partnership with Test Today USA LLC to provide mobile COVID-19 testing nationwide. Working together, Acupath and Test Today USA will launch specimen collection sites throughout the Northeast, including the NYC metro area, Upstate New York MERS CORONAVIRUS STUDY GIVES INSIGHTS INTO ZOONOTIC 1 day ago · An international study led by virologists at The University of Hong Kong (HKU) has shown that geographically and genetically distinct Middle East respiratory syndrome coronaviruses (MERS-CoV) from Africa have lower replication competence in human and mouse lung than those from the ME. These findings, reported in the June 7, 2021, online edition of Proceedings of the National Academy of STRESS SENSOR DJ-1 CAN HEIGHTEN OR DAMPEN INFLAMMATION 52 minutes ago · Investigators at the Tokyo Metropolitan Institute of Medical Science (TMIMS) have identified the oxidative stress sensor DJ-1 as a previously unknown inflammatory molecule which is released from damaged neurons to activate macrophages in post-stroke neuroinflammation. The team reported its results in the May 20, 2021, online issue of PLoS Biology. ICYMI: WEEK IN REVIEW, JUNE 1-4, 2021 Here’s a quick review of our lead stories from June 1-4, 2021. Missed an issue? You can find all the back issues here. FDA approves Chimerix’s brincidofovir to treat smallpox Following years of testing against a lengthy roster of viral foes, Chimerix Inc.’s Tembexa (brincidofovir) has finally won FDA approval as a medical countermeasure against smallpox. PRECIPIO LAUNCHES HEMESCREEN ANEMIA PANEL Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause. According to the World Health Organization, an estimated 1.62 billion people – 24% of people MED-TECH FINANCINGS TAKE A BACK SEAT TO 2020 1 day ago · The amount of money raised by medical technology companies in 2021 has dropped by about 26% in comparison with the same timeframe last year, although amounts from IPOs and venture capital rounds have more than doubled. By this point in 2020, $31.48 billion was raised through 282 transactions, while 2021 has so far brought in $23.3 billion through 311 financings, a 10% higher volume. CLINICAL TRIAL MANAGER SETTLES INSIDER TRADING CHARGE Holly Hand, a New York-based senior project manager overseeing a clinical trial for Neuralstem Inc. (now Seneca Biopharma Inc.), agreed to pay $103,875 to resolve an SEC complaint of insider trading. According to the SEC, when Hand learned of negative efficacy results from the trial, she tipped Chad Calice, who then sold his Neuralstem stock and tipped his uncle. INTELLIGENT IMPLANTS SCORES FDA BREAKTHROUGH NOD FOR Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions. The Smartfuse system is designed to provide electrical stimulation directly to the ITEMS TAGGED WITH 'ZOONOTIC DISEASE' An international study led by virologists at The University of Hong Kong has shown that geographically and genetically distinct Middle East respiratory syndrome coronaviruses (MERS-CoV) from Africa have lower replication competence in human and mouse lung than those fromthe ME
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Top News - Tuesday, April 14, 2020 BioWorld BioWorld MedTechBioWorld Asia
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ALNYLAM’S $2B DEAL WITH BLACKSTONE DESIGNED TO ADVANCE RNAIDEVELOPMENT
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