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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 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 1 day 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. 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. 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. 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 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. 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 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 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. 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. 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 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. 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 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 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.
RECORD PACE CONTINUES AS 2021 FINANCINGS RIVAL LAST YEAR Although 2020 is the highest money-making year on record for the biopharma industry, a direct comparison of the first five months indicates that the amount raised so far in 2021 is 22% ahead of last year, while the number of financings climbed 26%. The beginnings of the COVID-19 pandemic likely slowed activity during the early months of 2020, as 64% of the year’s $134.5 billion total was MERCK LANDS $1.2B SARS-COV-2 ANTIVIRAL SUPPLY DEAL WITH U 22 hours ago · Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback 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. 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. 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 JUNE 9, 2021 1 day ago · Able Medical Devices Inc., of Marquette, Mich., reported the recent launch of its Valkyrie thoracic fixation system, a single-use, radiolucent plating system designed to span the osteotomy and close the sternum after open heart surgery. New York-based Deerfield Healthcare Technology Acquisitions Corp. (DFHT), a special purpose acquisition company sponsored by Deerfield STRESS SENSOR DJ-1 CAN HEIGHTEN OR DAMPEN INFLAMMATION 1 day 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. FINANCINGS FOR JUNE 8, 2021 Cygenica Pvt. Ltd., of Pune, India, and Cork, Ireland, raised $1.4 million in a seed round led by SOSV. Other investors included the Voyager Health-Tech fund, David Rowan and angel investors Sharaf Yamani and Sami Mikati. The investment will be used to accelerate the development of its drug delivery technology for genome editing, which addresses the problem of delivering large-molecule 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
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. 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. 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 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. 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 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 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. 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. 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 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. 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 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 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.
MERCK LANDS $1.2B SARS-COV-2 ANTIVIRAL SUPPLY DEAL WITH U 11 hours ago · Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback 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. RECORD PACE CONTINUES AS 2021 FINANCINGS RIVAL LAST YEAR 1 day ago · Although 2020 is the highest money-making year on record for the biopharma industry, a direct comparison of the first five months indicates that the amount raised so far in 2021 is 22% ahead of last year, while the number of financings climbed 26%. The beginnings of the COVID-19 pandemic likely slowed activity during the early months of 2020, as 64% of the year’s $134.5 billion total was 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 STRESS SENSOR DJ-1 CAN HEIGHTEN OR DAMPEN INFLAMMATION 19 hours 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. OTHER NEWS TO NOTE FOR JUNE 8, 2021 Annovis Bio Inc., of Berwyn, Pa. announced preliminary data demonstrating ANVS-401 protects certain nerve cells from dying after being infected by gingipains, the virulence factors of Porphyromonas gingivalis (P. gingivalis), which have been identified as pathogenic effectors in Alzheimer’s disease. Annovis demonstrated that P. gingivalis and its associated proteases infect and MEDTRACE RAISES $30M TO EXPAND ITS 15O-WATER PLATFORM FOR Medtrace Pharma A/S raised $30 million in a series B round to ramp its platform for production, infusion and analysis of 15O-water in medical imaging. Swiss-based Swisscanto Invest, along with fund managers ATP and Bankinvest group from Denmark, are the lead investors. “We can now ramp our European and U.S. expansions plans in myocardial perfusion imaging and in other indications in need of 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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COOPERATIVE RESEARCH EFFORT TAKING AIM AT GENETICS AFFECTING COVID-19INFECTION
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