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BIOCENTURY - HOW COVID VACCINES MIGHT BE CAUSING BLOOD Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the adverse event is related to the vaccine modality and, if so, what the impact will be on ongoing and future adenoviral vector vaccine development. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVID The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; four tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. Two use TCID50 (median tissue culture infectious dose) per mL, and have very close values at 0.009 and 0.01 TCID50/mL. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL Apr 10, 2021 | 3:01 AM GMT. T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. BioCentury’s analysis of the. BIOCENTURY - HARMONIZING LIMITS OF DETECTION FOR FDA More than 20 diagnostic tests received emergency use authorization (EUA) by FDA for COVID-19 testing between February and April. Because banked patient samples were scarce, manufacturers largely reported each test’s limit of detection (LoD) — the lowest amount of a target that the test can detect at least 95% of the time — based onMARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION ASCO preview: TIGIT’s dual role in immunity could position it to lead among next-gen checkpoints. Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. Genentech is poised to present Phase II data that positions TIGIT as the firstBIOCENTURY
130+ Presentations from European and Asian biotechs handpicked by BioCentury. 1x1 virtual partnering using EBD's PartneringOne System. European biotech executive report from Insights Partner, McKinsey & Co. Opportunities for digital networking. BROADENING THE BRIDGE TO INNOVATION What are the latest trends shaping the biopharma industry in China? Based on interviews with biopharma C-suite from China and the West, the exclusive Running on the China Bridge to Innovation by McKinsey & Company was commissioned for the 6th BioCentury-BayHelix China Healthcare Summit (Nov. 18-20, 2019, Shanghai). BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS BioCentury - Biotech Industry News, Data and Analysis. Biocentury. A trusted and essential partner. to the biopharmaceutical. industry, providing 28 years. of in-depth research, analysis. and data on innovation. and excellence —. from biology to the patient. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP By C. Simone Fishburn, Editor In Chief. Mar 6, 2021 | 2:35 AM GMT. Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to market is reaching a trot, if not yet a gallop. Despite the hurdles, the regulatorybreakthroughs
BIOCENTURY - HOW COVID VACCINES MIGHT BE CAUSING BLOOD Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the adverse event is related to the vaccine modality and, if so, what the impact will be on ongoing and future adenoviral vector vaccine development. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVID The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; four tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. Two use TCID50 (median tissue culture infectious dose) per mL, and have very close values at 0.009 and 0.01 TCID50/mL. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL Apr 10, 2021 | 3:01 AM GMT. T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. BioCentury’s analysis of the. BIOCENTURY - HARMONIZING LIMITS OF DETECTION FOR FDA More than 20 diagnostic tests received emergency use authorization (EUA) by FDA for COVID-19 testing between February and April. Because banked patient samples were scarce, manufacturers largely reported each test’s limit of detection (LoD) — the lowest amount of a target that the test can detect at least 95% of the time — based onMARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION ASCO preview: TIGIT’s dual role in immunity could position it to lead among next-gen checkpoints. Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. Genentech is poised to present Phase II data that positions TIGIT as the firstBIOCENTURY
130+ Presentations from European and Asian biotechs handpicked by BioCentury. 1x1 virtual partnering using EBD's PartneringOne System. European biotech executive report from Insights Partner, McKinsey & Co. Opportunities for digital networking. BROADENING THE BRIDGE TO INNOVATION What are the latest trends shaping the biopharma industry in China? Based on interviews with biopharma C-suite from China and the West, the exclusive Running on the China Bridge to Innovation by McKinsey & Company was commissioned for the 6th BioCentury-BayHelix China Healthcare Summit (Nov. 18-20, 2019, Shanghai). BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication. Companies and investigators with compounds to add should submit the details using the Research Gateway. To report updates to products already listed inthe Resource Center
BIOCENTURY - FINANCE April 15 Quick Takes: Co-founded by Springer and Kruse, GPCR play Tectonic raises $80M; plus AltruBio, Rapha, Benchling, BioAge, Amgen. Tectonic Therapeutic Inc. debuted with an $80 million series A round co-led by Vida Ventures, T.A. Springer, and Polaris Partners BIOCENTURY - BIOCENTURY MANAGEMENT Karen is Co-Founder and Chairman of BioCentury Inc. and was Editor in Chief from October 1992 to August 2015. She is a director at Ovid Therapeutics Inc., which is developing drugs for orphan diseases of the brain, and at Codiak Biosciences Inc., which is engineeringexosomes
CONTACT BIOCENTURY
1235 Radio Road, Ste. 100 Redwood City, CA 94065-1217 Ph: +1 650-595-5333 Fx: +1 650-595-5589 BIOCENTURY - EDITORIAL & RESEARCH TEAM To send a press release or to contact the editorial department, email news@biocentury.com.. Editors SIMONE FISHBURN, PH.D., VICE PRESIDENT & EDITOR IN CHIEF. Simone serves as Vice President and Editor in Chief, bringing experience from both industry and academia in translational science, where she focused for over 15 years on the scientific, commercial and strategic considerations for BIOCENTURY - JUNE 8 QUICK TAKES: FDA APPROVES PREVNAR 20 CDC’s Advisory Committee on Immunization Practices (ACIP) will meet in October to discuss and update recommendations on adult immunizations with pneumococcal vaccines including Prevnar 20 from Pfizer Inc. (NYSE:PFE) after its approval late Tuesday. According to the company, it’s the first approval of a conjugate vaccine that helps protect against BIOCENTURY - NEURO DEAL FLOW: PHARMAS PINNING HOPES ON NEW BioCentury & Getty Images Deals Neuro deal flow: pharmas pinning hopes on new modalities, delivery technologies The last three years of deals prioritize new modalities against known targets and CNS entry over discovery of new targets BIOCENTURY - BIO’S MCMURRY-HEATH TOPS WHITE HOUSE FDA BIO’s McMurry-Heath tops White House FDA commissioner list. McMurry-Heath aligned with several issues in Biden agenda, but has stance on IP that could be controversial with Democrats. BIO CEO Michelle McMurry-Heath is aligned with several issues at the heart of the Biden administration’s agenda, but she has industry ties and astance on IP
BIOCENTURY - LARONDE: PROGRAMMABLE, MODULAR CIRCULAR RNA Laronde: programmable, modular circular RNA therapies. Emerging Company Profile: Flagship launches Laronde with $50M and versatile platform for RNA delivery. Flagship company Laronde is developing a circular RNA therapy platform that is longer-lasting than linear mRNA and avoids the immunogencity of viral vector gene therapies. BIOCENTURY - DE-RISKING RISK REDUCTION Slow and inconsistent reimbursement practices coupled with a lack of data on health or economic outcomes at launch often slows uptake of new, high-priced molecular diagnostics and sequencing-based tests. BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS BioCentury - Biotech Industry News, Data and Analysis. Biocentury. A trusted and essential partner. to the biopharmaceutical. industry, providing 28 years. of in-depth research, analysis. and data on innovation. and excellence —. from biology to the patient. BIOCENTURY - COVID-19 THERAPIES AND VACCINES: CLINICAL BioCentury is tracking vaccines and therapeutics being studied for COVID-19. The list contains compounds that are approved in any territory, or that have entered clinical trials for COVID-19 or any other indication. Companies and investigators with compounds to add should submit the details using the Research Gateway. BIOCENTURY - HOW COVID VACCINES MIGHT BE CAUSING BLOOD Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the adverse event is related to the vaccine modality and, if so, what the impact will be on ongoing and future adenoviral vector vaccine development. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP By C. Simone Fishburn, Editor In Chief. Mar 6, 2021 | 2:35 AM GMT. Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to market is reaching a trot, if not yet a gallop. Despite the hurdles, the regulatorybreakthroughs
BIOCENTURY - SINOVAC COVID-19 VACCINE YIELDS NEUTRALIZING Sinovac’s disclosure over the weekend of early clinical data from its COVID-19 vaccine makes it the third company to demonstrate production of neutralizing antibodies in humans, behind Moderna andCanSino.
BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVID The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; four tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. Two use TCID50 (median tissue culture infectious dose) per mL, and have very close values at 0.009 and 0.01 TCID50/mL. BIOCENTURY - HARMONIZING LIMITS OF DETECTION FOR FDA More than 20 diagnostic tests received emergency use authorization (EUA) by FDA for COVID-19 testing between February and April. Because banked patient samples were scarce, manufacturers largely reported each test’s limit of detection (LoD) — the lowest amount of a target that the test can detect at least 95% of the time — based onMARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION ASCO preview: TIGIT’s dual role in immunity could position it to lead among next-gen checkpoints. Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. Genentech is poised to present Phase II data that positions TIGIT as the firstBIOCENTURY
130+ Presentations from European and Asian biotechs handpicked by BioCentury. 1x1 virtual partnering using EBD's PartneringOne System. European biotech executive report from Insights Partner, McKinsey & Co. Opportunities for digital networking. BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS BioCentury - Biotech Industry News, Data and Analysis. Biocentury. A trusted and essential partner. to the biopharmaceutical. industry, providing 28 years. of in-depth research, analysis. and data on innovation. and excellence —. from biology to the patient. BIOCENTURY - COVID-19 THERAPIES AND VACCINES: CLINICAL BioCentury is tracking vaccines and therapeutics being studied for COVID-19. The list contains compounds that are approved in any territory, or that have entered clinical trials for COVID-19 or any other indication. Companies and investigators with compounds to add should submit the details using the Research Gateway. BIOCENTURY - HOW COVID VACCINES MIGHT BE CAUSING BLOOD Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the adverse event is related to the vaccine modality and, if so, what the impact will be on ongoing and future adenoviral vector vaccine development. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP By C. Simone Fishburn, Editor In Chief. Mar 6, 2021 | 2:35 AM GMT. Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to market is reaching a trot, if not yet a gallop. Despite the hurdles, the regulatorybreakthroughs
BIOCENTURY - SINOVAC COVID-19 VACCINE YIELDS NEUTRALIZING Sinovac’s disclosure over the weekend of early clinical data from its COVID-19 vaccine makes it the third company to demonstrate production of neutralizing antibodies in humans, behind Moderna andCanSino.
BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVID The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; four tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. Two use TCID50 (median tissue culture infectious dose) per mL, and have very close values at 0.009 and 0.01 TCID50/mL. BIOCENTURY - HARMONIZING LIMITS OF DETECTION FOR FDA More than 20 diagnostic tests received emergency use authorization (EUA) by FDA for COVID-19 testing between February and April. Because banked patient samples were scarce, manufacturers largely reported each test’s limit of detection (LoD) — the lowest amount of a target that the test can detect at least 95% of the time — based onMARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION ASCO preview: TIGIT’s dual role in immunity could position it to lead among next-gen checkpoints. Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. Genentech is poised to present Phase II data that positions TIGIT as the firstBIOCENTURY
130+ Presentations from European and Asian biotechs handpicked by BioCentury. 1x1 virtual partnering using EBD's PartneringOne System. European biotech executive report from Insights Partner, McKinsey & Co. Opportunities for digital networking. BIOCENTURY - COVID-19 THERAPIES AND VACCINES: CLINICAL BioCentury is tracking vaccines and therapeutics being studied for COVID-19. The list contains compounds that are approved in any territory, or that have entered clinical trials for COVID-19 or any other indication. Companies and investigators with compounds to add should submit the details using the Research Gateway. BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication. Companies and investigators with compounds to add should submit the details using the Research Gateway. To report updates to products already listed inthe Resource Center
BIOCENTURY - BIOCENTURY MANAGEMENT Karen is Co-Founder and Chairman of BioCentury Inc. and was Editor in Chief from October 1992 to August 2015. She is a director at Ovid Therapeutics Inc., which is developing drugs for orphan diseases of the brain, and at Codiak Biosciences Inc., which is engineeringexosomes
BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSIS International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding. BIOCENTURY - ADUCANUMAB APPROVAL SETS PRECEDENT FOR FDA’s accelerated approval of Biogen’s aducanumab to treat Alzheimer’s creates a path for approvals based on surrogate endpoints of other neurodegenerative disease therapies. BIOCENTURY - NOVAVAX ANNOUNCES HIGH NEUTRALIZING ANTIBODY A COVID-19 candidate vaccine from Novavax has produced the highest reported levels of neutralizing titers in non-human primate studies. “We are seeing neutralizing titers in the 10,000 range in non-human primates,” Gregory Glenn, president of R&D at Novavax Inc. (NASDAQ:NVAX), said Tuesday in a presentation to the BIO annualmeeting.
BCIQ - BIOCENTURY
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - FDA’S ADUCANUMAB DECISION WILL ERODE PUBLIC In granting accelerated approval to aducanumab from Biogen, FDA has weakened the bonds of trust that are its greatest strength. The action doesn’t mean FDA will approve drugs based on post hoc statistical manipulations, that it will be swayed by politically potent patient groups, or that it will treat advisory committee deliberations as decoration for decisions that have already been made BIOCENTURY - BIOGEN UNSWAYED BY ICER ASSESSMENT IN Biogen’s list price for aducanumab would only be cost-effective for a drug that completely halted dementia progression, according to ICER, adding controversy to the already contentious debate BIOCENTURY - LARONDE: PROGRAMMABLE, MODULAR CIRCULAR RNA Laronde: programmable, modular circular RNA therapies. Emerging Company Profile: Flagship launches Laronde with $50M and versatile platform for RNA delivery. Flagship company Laronde is developing a circular RNA therapy platform that is longer-lasting than linear mRNA and avoids the immunogencity of viral vector gene therapies. BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding. BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication.MARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - WILL BIOCON’S COVID-19 ANTI-INFLAMMATORY With an Indian EUA for Alzumab, Biocon is now planning to run larger studies and collect real-world data that can demonstrate the CD6 inhibitor can effectively dampen the cytokine storm observed in severe COVID-19 patients, a feat IL-6 inhibitors have yet to demonstrate. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVIDFDA LIMIT OF DETECTIONLIMIT OF DETECTION VS METHOD DETECTION LIMITDETECTION LIMIT CALCULATEDETECTION LIMIT VS QUANTITATION LIMITMETHOD DETECTION LIMITLIMIT OF DETECTION DETERMINATION An assay's LoD is the lowest amount of the target that the test can detect at least 95% of the time. A lower LoD indicates a moresensitive test.
BIOCENTURY - PUSHING LIMITS OF DETECTION FOR THE NEW More than 25 diagnostic tests have received Emergency Use Authorization (EUA) by FDA for COVID-19 testing in the last two months. The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; five tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. BIOCENTURY - REPRINTS & PERMISSIONS We welcome IR/PR professionals or organizational representatives to order reprints for distribution in investor kits, for conferences, and for recruiting – or any other purpose where the credibility of BioCentury articles is invaluable. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP BioCentury & Getty Images Product Development The pace of new modality approvals is picking up Close to 30 new modality drugs approved in the last five years, and about 50 in BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL BioCentury & Getty Images Product Development Bispecific constructs move beyond T cell engagers at AACR Next-generation immune cell engagers and bispecific checkpoints gain ground on T cell engagers atAACR21
BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding. BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication.MARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - WILL BIOCON’S COVID-19 ANTI-INFLAMMATORY With an Indian EUA for Alzumab, Biocon is now planning to run larger studies and collect real-world data that can demonstrate the CD6 inhibitor can effectively dampen the cytokine storm observed in severe COVID-19 patients, a feat IL-6 inhibitors have yet to demonstrate. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVIDFDA LIMIT OF DETECTIONLIMIT OF DETECTION VS METHOD DETECTION LIMITDETECTION LIMIT CALCULATEDETECTION LIMIT VS QUANTITATION LIMITMETHOD DETECTION LIMITLIMIT OF DETECTION DETERMINATION An assay's LoD is the lowest amount of the target that the test can detect at least 95% of the time. A lower LoD indicates a moresensitive test.
BIOCENTURY - PUSHING LIMITS OF DETECTION FOR THE NEW More than 25 diagnostic tests have received Emergency Use Authorization (EUA) by FDA for COVID-19 testing in the last two months. The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; five tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. BIOCENTURY - REPRINTS & PERMISSIONS We welcome IR/PR professionals or organizational representatives to order reprints for distribution in investor kits, for conferences, and for recruiting – or any other purpose where the credibility of BioCentury articles is invaluable. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP BioCentury & Getty Images Product Development The pace of new modality approvals is picking up Close to 30 new modality drugs approved in the last five years, and about 50 in BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL BioCentury & Getty Images Product Development Bispecific constructs move beyond T cell engagers at AACR Next-generation immune cell engagers and bispecific checkpoints gain ground on T cell engagers atAACR21
BIOCENTURY - COVID-19 RESOURCE CENTER Regulation Why FDA may raise the bar for COVID vaccine authorizations . FDA announced Tuesday that it may limit its review of emergency use authorization requests for COVID-19 vaccines to those developed by sponsors that have been working closely with the agency. BIOCENTURY - COMPANY OVERVIEW BioCentury gives biopharma executives, investors and institutions the power to make business-critical decisions through independent, deep-dive analysis; high-quality data; and industry-leading business intelligence, and global events. BIOCENTURY - FINANCE International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding.CONTACT BIOCENTURY
1235 Radio Road, Ste. 100 Redwood City, CA 94065-1217 Ph: +1 650-595-5333 Fx: +1 650-595-5589 BIOCENTURY - EDITORIAL & RESEARCH TEAM To send a press release or to contact the editorial department, email news@biocentury.com.. Editors SIMONE FISHBURN, PH.D., VICE PRESIDENT & EDITOR IN CHIEF. Simone serves as Vice President and Editor in Chief, bringing experience from both industry and academia in translational science, where she focused for over 15 years on the scientific, commercial and strategic considerations for BIOCENTURY - WHO MEETING HIGHLIGHTS CORRELATES OF A Wednesday meeting hosted by WHO seeking to clarify the next steps in defining correlates of protection for next-generation COVID-19 vaccines underscored the need to determine if prediction thresholds can be harmonized across modalities and whether serum markers are valid predictors of efficacy for vaccines aiming for strong mucosalimmunity.
BIOCENTURY - MAY 25 QUICK TAKES: MODERNA TO SUBMIT Moderna Inc. (NASDAQ:MRNA) will be the next company to bring a COVID-19 vaccine forward for authorization in adolescents, with plansto submit data from
BIOCENTURY - GOING BEYOND GENETIC MEDICINES FOR MUSCULAR BioCentury & Getty Images Targets & Mechanisms Going beyond genetic medicines for muscular dystrophy Muscular dystrophy programs in the clinic cover not only a range of muscle mechanisms but also anti-fibrotic and anti-inflammation ones BIOCENTURY - WHY FDA, BIOGEN SHOULD BE UNUSUALLY BioCentury & Getty Images Editor’s Commentary Why FDA, Biogen should be unusually transparent with aducanumab data: an Editor’s Commentary The best way to convince the public that FDA made the right decision — whatever decision it makes — is for FDA and Biogen to lay all their cards on the table. BIOCENTURY - HOW TWO NEW FORESITE DEALS BUILD ON THE FIRM Two new deals by Foresite build on a theme that began with its investment in Relay, illustrating how the firm is thinking about applying computing and visualization technologies to protein dynamics, BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding. BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication.MARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - WILL BIOCON’S COVID-19 ANTI-INFLAMMATORY With an Indian EUA for Alzumab, Biocon is now planning to run larger studies and collect real-world data that can demonstrate the CD6 inhibitor can effectively dampen the cytokine storm observed in severe COVID-19 patients, a feat IL-6 inhibitors have yet to demonstrate. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVIDFDA LIMIT OF DETECTIONLIMIT OF DETECTION VS METHOD DETECTION LIMITDETECTION LIMIT CALCULATEDETECTION LIMIT VS QUANTITATION LIMITMETHOD DETECTION LIMITLIMIT OF DETECTION DETERMINATION An assay's LoD is the lowest amount of the target that the test can detect at least 95% of the time. A lower LoD indicates a moresensitive test.
BIOCENTURY - PUSHING LIMITS OF DETECTION FOR THE NEW More than 25 diagnostic tests have received Emergency Use Authorization (EUA) by FDA for COVID-19 testing in the last two months. The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; five tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. BIOCENTURY - REPRINTS & PERMISSIONS We welcome IR/PR professionals or organizational representatives to order reprints for distribution in investor kits, for conferences, and for recruiting – or any other purpose where the credibility of BioCentury articles is invaluable. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP BioCentury & Getty Images Product Development The pace of new modality approvals is picking up Close to 30 new modality drugs approved in the last five years, and about 50 in BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL BioCentury & Getty Images Product Development Bispecific constructs move beyond T cell engagers at AACR Next-generation immune cell engagers and bispecific checkpoints gain ground on T cell engagers atAACR21
BIOCENTURY - BIOTECH INDUSTRY NEWS, DATA AND ANALYSISARTICLESCURRENT EDITIONSSEARCH ARCHIVESBCIQCONFERENCESWHITE PAPERS International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding. BIOCENTURY - COVID-19 VACCINES AND THERAPIES: PRECLINICAL BioCentury is tracking vaccines and therapeutics for COVID-19. The list below contains compounds that have not advanced beyond preclinical development for any indication.MARKETING - BCIQ
For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and BIOCENTURY - WILL BIOCON’S COVID-19 ANTI-INFLAMMATORY With an Indian EUA for Alzumab, Biocon is now planning to run larger studies and collect real-world data that can demonstrate the CD6 inhibitor can effectively dampen the cytokine storm observed in severe COVID-19 patients, a feat IL-6 inhibitors have yet to demonstrate. BIOCENTURY - LIMITS OF DETECTION FOR FDA-AUTHORIZED COVIDFDA LIMIT OF DETECTIONLIMIT OF DETECTION VS METHOD DETECTION LIMITDETECTION LIMIT CALCULATEDETECTION LIMIT VS QUANTITATION LIMITMETHOD DETECTION LIMITLIMIT OF DETECTION DETERMINATION An assay's LoD is the lowest amount of the target that the test can detect at least 95% of the time. A lower LoD indicates a moresensitive test.
BIOCENTURY - PUSHING LIMITS OF DETECTION FOR THE NEW More than 25 diagnostic tests have received Emergency Use Authorization (EUA) by FDA for COVID-19 testing in the last two months. The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; five tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. BIOCENTURY - REPRINTS & PERMISSIONS We welcome IR/PR professionals or organizational representatives to order reprints for distribution in investor kits, for conferences, and for recruiting – or any other purpose where the credibility of BioCentury articles is invaluable. BIOCENTURY - THE PACE OF NEW MODALITY APPROVALS IS PICKING UP BioCentury & Getty Images Product Development The pace of new modality approvals is picking up Close to 30 new modality drugs approved in the last five years, and about 50 in BIOCENTURY - TIGIT BREAKS THROUGH AS NEXT-GENERATION Next-generation checkpoint inhibitors will take the limelight at the 2020 virtual ASCO meeting, with all eyes on TIGIT as the first to back up the noise with data. BIOCENTURY - BISPECIFIC CONSTRUCTS MOVE BEYOND T CELL BioCentury & Getty Images Product Development Bispecific constructs move beyond T cell engagers at AACR Next-generation immune cell engagers and bispecific checkpoints gain ground on T cell engagers atAACR21
BIOCENTURY - COVID-19 RESOURCE CENTER Regulation Why FDA may raise the bar for COVID vaccine authorizations . FDA announced Tuesday that it may limit its review of emergency use authorization requests for COVID-19 vaccines to those developed by sponsors that have been working closely with the agency. BIOCENTURY - COMPANY OVERVIEW BioCentury gives biopharma executives, investors and institutions the power to make business-critical decisions through independent, deep-dive analysis; high-quality data; and industry-leading business intelligence, and global events. BIOCENTURY - FINANCE International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding.CONTACT BIOCENTURY
1235 Radio Road, Ste. 100 Redwood City, CA 94065-1217 Ph: +1 650-595-5333 Fx: +1 650-595-5589 BIOCENTURY - EDITORIAL & RESEARCH TEAM To send a press release or to contact the editorial department, email news@biocentury.com.. Editors SIMONE FISHBURN, PH.D., VICE PRESIDENT & EDITOR IN CHIEF. Simone serves as Vice President and Editor in Chief, bringing experience from both industry and academia in translational science, where she focused for over 15 years on the scientific, commercial and strategic considerations for BIOCENTURY - WHO MEETING HIGHLIGHTS CORRELATES OF A Wednesday meeting hosted by WHO seeking to clarify the next steps in defining correlates of protection for next-generation COVID-19 vaccines underscored the need to determine if prediction thresholds can be harmonized across modalities and whether serum markers are valid predictors of efficacy for vaccines aiming for strong mucosalimmunity.
BIOCENTURY - MAY 25 QUICK TAKES: MODERNA TO SUBMIT Moderna Inc. (NASDAQ:MRNA) will be the next company to bring a COVID-19 vaccine forward for authorization in adolescents, with plansto submit data from
BIOCENTURY - GOING BEYOND GENETIC MEDICINES FOR MUSCULAR BioCentury & Getty Images Targets & Mechanisms Going beyond genetic medicines for muscular dystrophy Muscular dystrophy programs in the clinic cover not only a range of muscle mechanisms but also anti-fibrotic and anti-inflammation ones BIOCENTURY - WHY FDA, BIOGEN SHOULD BE UNUSUALLY BioCentury & Getty Images Editor’s Commentary Why FDA, Biogen should be unusually transparent with aducanumab data: an Editor’s Commentary The best way to convince the public that FDA made the right decision — whatever decision it makes — is for FDA and Biogen to lay all their cards on the table. BIOCENTURY - HOW TWO NEW FORESITE DEALS BUILD ON THE FIRM Two new deals by Foresite build on a theme that began with its investment in Relay, illustrating how the firm is thinking about applying computing and visualization technologies to protein dynamics, Back to School: How biopharma can reboot drug development. _ACCESS EXCLUSIVE ANALYSIS HERE_* Articles
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Product Development
COULD AN APPROVAL OF BIOGEN’S ALZHEIMER’S THERAPY STILL BE ANOPTION?
For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishinglyRead More
Politics, Policy & Law FATE OF TRUMP’S 11TH HOUR DRUG PRICE RULES UNCERTAIN If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administrationFriday
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Product Development
HOW FORMA IS WORKING TO SHOW THE SICKLE CELL COMMUNITY IT’S IN FORTHE LONG HAUL
As early clinical evidence for its sickle cell disease candidate grows, Forma is prioritizing building relationships with the patient community, with a focus on long-term policy goals and COVID-19Read More
Finance
SR ONE’S NEWFOUND FREEDOM ALLOWS FIRM TO INCREASE FOCUS ON COMPANYCREATION
SR One’s spinout from GSK gives the newly independent VC the ability to scale up what has been a top-tier investment firm over the past decade, along with the freedom to take larger stakes inRead More
Product Development
PHASE III COVID-19 VACCINE DATA KICK-START NEXT PHASE: MAPPINGEFFICACY TO
Efficacy data from the first two Phase III trials of COVID-19 vaccines shattered expectations and validated mRNA as a vaccine modality. The findings also mark the start of the search for correlates ofRead More
LATEST ARTICLES
Product Development ASH preview & long shot drug pricing rules: aBioCentury podcast
On the latest edition of the BioCentury This Week podcast, BioCentury editors discuss how emerging targets, modalities and indications are stacking up at the upcoming American Society of Hematology...Read More
Product Development AstraZeneca’s data add another landmark on the road to correlates of protection for COVID-19: Data Byte Phase III data from a third COVID-19 vaccine, AstraZeneca’s AZD1222, shed more light on the neutralization titers needed to confer protection and have implications for othervaccines...
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Product Development Less is more: If AZ’s low-dose COVID-19 vaccine regimen works better, more people will benefit Regardless of why the full-dose regimen of AstraZeneca’s COVID-19 vaccine performed worse than a partial-dose regimen, better efficacy with less vaccine means supplies will stretch...Read More
Product Development Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against...Read More
Deals OncoImmune's choice to repurpose GvHD program for COVID pays off via $425M takeout by Merck OncoImmune’s move to repurpose its GvHD program for COVID-19 has paid off via a takeout by Merck for $425 million up front. Under the deal, which includes undisclosed milestones and royalties,...Read More
Management Tracks ASCO names Gralow new CMO; plus moves at Genenta, Vor, Exscientia, OncoMyx, Quanterix, Actinium, AbCellera and KBP The American Society of Clinical Oncology named Julie Gralow CMO, effective Feb. 15, 2021. Gralow, a professor of medical oncology and director of breast medical oncology at the University of...Read More
Product Development Immunocore charts the path for bispecifics in solid tumors with Phase III readout With a positive Phase III readout in metastatic uveal melanoma, Immunocore has become the first company to solve one of the biggest challenges in immuno-oncology: applying T cell-engaging bispecifics...Read More
Politics, Policy & Law PhRMA commitment to boosting trial diversity emphasizes community trust and outreach The first problem area PhRMA seeks to address through its trial diversity guidelines, released last week, is the lack of trust among underserved communities when it comes to clinical studies. ...Read More
Deals Cytokinetics evaluating path forward for heart disease treatment after Amgen ends partnership Cytokinetics is assessing whether to commercialize omecamtiv mecarbil on its own or to seek a new partner after Amgen returned the heart failure treatment’s rights, ending a 2006 deal....Read More
Emerging Company Profile SV Health-incubated Catamaran debuts with $42M to develop CAR NK pipeline Catamaran debuted Monday with a $42 million series A round to advance a pipeline of allogeneic CAR NK cell therapies that seed investor SV Health hopes can “democratize access to cell...Read More
Regulation Distribution of Regeneron’s COVID-19 antibody cocktail tobegin Tuesday
Starting Tuesday, distribution of Regeneron’s antibody cocktail for COVID-19 will begin via an existing network of hospitals and associated facilities, with plans for a subsequent expansion...Read More
Product Development Could an approval of Biogen’s Alzheimer’s therapy still be an option? For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly...Read More
Politics, Policy & Law Fate of Trump’s 11th hour drug price rulesuncertain
If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administrationFriday...
Read More
Finance Mei readies Antengene to take its next steps to becoming aglobal biotech
Fresh off its $360 million IPO on the Hong Kong stock exchange, Shanghai’s Antengene is looking to take the next step in its evolution by building out its pipeline and launching its firstdrug....
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Product Development How Forma is working to show the sickle cell community it’s in for the long haul As early clinical evidence for its sickle cell disease candidate grows, Forma is prioritizing building relationships with the patient community, with a focus on long-term policy goals and COVID-19...Read More
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