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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.
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 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 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 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.
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 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 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 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. 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, has been investigating the 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 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. 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 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 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 U.S. FDA ENCOURAGING COVID-19 TEST DEVELOPERS TO FILE 510 The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are 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 SARSSTAFF - 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. 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 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 FDA REVEALS DEPTH OF MANUFACTURING ISSUES AT EMERGENTAUTHOR: MARISEREBROV
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 SARSSTAFF - 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. 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 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 FDA REVEALS DEPTH OF MANUFACTURING ISSUES AT EMERGENTAUTHOR: MARISEREBROV
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.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.
PROSTATE CANCERS ILLUSTRATE EQUITY’S PREREQUISITES AT ASCO At the 2021 virtual annual meeting of the American Society for Clinical Oncology (ASCO), results of the VISION trial testing the addition of Novartis AG’s radiopharmaceutical Lutetium-177-PSMA-617 (Lutetium-PSMA) to individualized standard-of-care regimens in metastatic castration-resistant prostate cancer improved both overall survival and radiographic progression-free survival. STRESS SENSOR DJ-1 CAN HEIGHTEN OR DAMPEN INFLAMMATION 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. 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 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. 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 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. 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 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 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 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.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. 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 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 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. 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. 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. 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.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. 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 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 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. 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. 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. BIOWORLD: THE DAILY BIOPHARMACEUTICAL AND MEDICAL 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. 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. BIOWORLD MEDTECH: THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist 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 SCOHIA SECURES ENTRY INTO GREATER CHINA MARKET WITH 8 hours ago · Scohia Pharma Inc. has secured an agreement with Huadong Medicine Co. Ltd., enabling the former to tap the greater China market for SCO-094, its GLP-1R and GIPR dual agonist. The agreement sees Fujisawa, Japan-based Schohia partner with Huadong subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. to develop, manufacture and commercialize SCO-094 for treating diabetes, FIRST DEPLOYABLE COVID-19 DETECTION SYSTEM TARGETS SCHOOL With the U.S. launch of the first deployable airborne COVID-19 detection system, Bioflyte Inc. is working to provide effective ways to sample the air and deliver results within an hour. The Sentinel integrated solution aims to prevent widespread infection in schools and workplaces. Bioflyte had some competition prior to launching its new system earlier this month, but the combined features 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 APPOINTMENTS AND ADVANCEMENTS FOR JUNE 7, 2021 Burlingame, Calif.-based Cala Health Inc. has expanded its executive team with Steve Higa as vice president, manufacturing and quality, and Greg Schulte, as vice president, hardware. Gynesonics Inc., of Redwood City, Calif., appointed David Pacitti to chair its board of directors. Newton, Mass.-based Onduo LLC has appointed Erich Huang to be chief science and innovation officer. OTHER NEWS TO NOTE + 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* Sign In
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Top News - Tuesday, March 10, 2020 BioWorldBioWorld MedTechBioWorld AsiaBIOWORLD
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COMPETITION APLENTY AS NOVARTIS’ ISTURISA IS FDA-APPROVED TO TREATCUSHING’S DISEASE
With the FDA approval of Novartis AG’s Isturisa (osilodrostat), an oral treatment for adults with Cushing’s disease, Recordati SpA, of Milan, is planning its U.S. market...*
WHO RELEASES COVID-19 ROADMAP; FUNDING EFFORTS IN PROGRESS*
BIOPHARMA EQUITIES CAUGHT IN VORTEX OF OIL CRASH AND CORONAVIRUS FEARS*
KALA SENDS UP ‘FLARE’ IN DED; PHASE III POSITIVE, BRISK STRIDE TONDA RE-TRY
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RESEARCHERS PHONING IT IN AT ALL-VIRTUAL 2020 CROI MEETING*
TODAY'S NEWS IN BRIEF*
HARBOUR, MOUNT SINAI PARTNER TO DEVELOP MABS TARGETING CANCER, IMMUNOLOGY AND CORONAVIRUS*
TWO-YEAR DATA BUOY HANSA’S IMLIFIDASE MAA AS CHMP DECISION LOOMS*
HURDLES TO ROBUST U.S. BIOSIMILAR MARKET IN THE EYE OF THE BEHOLDER*
WEEK IN REVIEW FOR MARCH 2-6, 2020: FINANCIAL MARKETS IN FREEFALLMore in BioWorld
BIOWORLD MEDTECH
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INSIGHTEC AIMS FOR $150M IN SERIES F ROUND Tirat Carmel, Israel-based Insightec Ltd. has inked a deal for a series F financing of up to $150 million led by Koch Disruptive Technologies (KDT), a subsidiary of Koch...*
ENVISION INTEGRATES AI-POWERED SOFTWARE TECH INTO GOOGLE GLASS*
TODAY'S NEWS IN BRIEF*
BMS PARTNERS WITH VOLUNTIS TO DEVELOP ONCOLOGY DIGITAL THERAPEUTICS*
ZIPTECK DEVELOPS NOVEL ORTHOPEDIC FIXATION DEVICE*
BIOWORLD MEDTECH’S CARDIOLOGY EXTRA FOR MARCH 9, 2020*
ADVAMED’S VAN METER: ‘TIME IS NOW TO ACT’ ON LDT REGULATORYREFORM
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FDA GRANTS BREAKTHROUGH NOD FOR NEUROSTAR IN BIPOLAR DEPRESSION*
NEWPRO3D HELPING GERMAN COMPANY EXPAND INTO ADDITIVE MANUFACTURING OFMEDICAL DEVICES
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IBEX SECURES CE-IVD MARK FOR AI-POWERED DECISION SUPPORT SYSTEM FORCANCER
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THINK OF MORE THAN JUST SPEED IN THE COVID-19 VACCINE RACE, EXPERTSSAY
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced Feb. 24 that it has shipped the first vials of its mRNA vaccine against COVID-19 for a...*
DON’T REPURPOSE, BUT DEVELOP BETTER DRUGS, EXPERTS SAY*
COULD GSK REJECT BENEFIT COVID-19 PATIENTS?*
INCREASING NUMBER OF BIOPHARMA DRUGS TARGET COVID-19 AS VIRUS SPREADS*
NEWS IN BRIEF
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COVID-19: EU LAUNCHES RESPONSE TEAM TO COORDINATE EFFORTS*
SINGAPORE’S TESSA GAINS U.S. RMAT DESIGNATION FOR CD30 CAR T, EXPANDS MANUFACTURING EFFORTS*
IMMUTEP REPORTS POSITIVE INTERIM PHASE II RESULTS IN KEYTRUDA COMBOBASKET TRIAL
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WITH BREXIT SPLIT, AUSTRALIA READY WITH BACK-UP PLAN FOR DRUGS AND DEVICES FOLLOWING TRANSITION*
MBD AND AZOTHBIO PARTNER FOR RARE CANCER DRUG USING AI MODELINGTECHNOLOGY
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