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5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K. Study expanded to 15,000 participants Full enrollment expected by end of November Event-driven interim data expected as soon as early first quarter 2021 U.S. pivotal Phase … Continue reading → GlobeNewswire MORE
The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report. MORE
Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. MORE
Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines. MORE
Press Release 30 September 2020 Immunicum AB Announces Update on Corporate and Clinical Development Strategy Immunicum AB (publ: IMMU.ST) announced today an update on the Company’s corporate and clinical development strategy. The strategy will be presented by members of the … Continue reading → GlobeNewswire MORE
Million Placement to Accelerate and Broaden its Clinical Development Immutep Completes a A$29.6 Million Placement to Accelerate and Broaden its Clinical Development Sydney, Australia, Nov. Immutep Completes a A$29.6 19, 2020 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) … Continue reading → GlobeNewswire MORE
Clinical DevelopmentBioclinicaâs Image Redact AI tool enables trials to edit sensitive information from videos, photos and PDFs to ensure compliance and safeguard patient data. MORE
Clinical-stage biopharmaceutical firm ESCAPE Bio has snagged a $73 million crossover financing deal, led by Wellington Management Company, which will help advance the company’s two clinical development programs of precision neurology medicines for patients with genetic neurodegeneration MORE
Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (IT) formulation in older patients with SMA to further support registration Basel, September 23, 2020 – Novartis Gene Therapies recently received feedback from the US … Continue reading → GlobeNewswire MORE
STALICLA Translates its Novel Precision Medicine Approach for Autism Spectrum Disorder into Clinical Development with First Patient in Phase 1b Trial of STP1 STALICLA Translates its Novel Precision Medicine Approach for Autism Spectrum Disorder into Clinical Development with First Patient … Continue reading → Business Wire MORE
Clinical DevelopmentAmerican Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC. MORE
Enables compliant, timely surveillance and outcomes research to help get safe and effective therapies to patients faster NEW YORK & CAMBRIDGE, Mass. & & SAN FRANCISCO–(BUSINESS WIRE)–Medidata, a Dassault Systèmes company, TriNetX, and Datavant announced a partnership that will accelerate the … Continue reading → Business Wire MORE
Clinical DevelopmentA study by two trial technology firms reportedly indicates that decentralized trials are outperforming on-site in recruitment, retention and other aspects. MORE
Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. Prior to joining industry, she was clinical professor at NYU Langone Medical Center and director of Hepatology at NYU Plainview, NY. SHANGHAI , Nov. MORE
Clinical DevelopmentThe founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach. MORE
The Verisense Pulse+ can measure heart rate, oxygen saturation, emotional responses, and activity and sleep levels of at-home clinical trial participants. Clinical Development MORE
GHENT, Belgium–(BUSINESS WIRE)–Confo Therapeutics today announced the selection of its first preclinical drug candidate, CFTX-1554, a compound designed to address peripheral neuropathic pain with the potential to address additional pain indications. MORE
Clinical DevelopmentA leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals. MORE
Clinical DevelopmentThe agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality. MORE
Clinical DevelopmentA leader from Vocalis Health explains how health data can be culled from patient voice recordings to screen and monitor COVID-19 and other conditions. MORE
Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. MORE
Clinical DevelopmentAccording to Noxopharm, a recent study shows combining its Veyonda drug and a radiopharmaceutical yields favorable results against prostate cancer. MORE
Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges. Clinical Development MORE
TPG Capital establishes new entity to continue the development of select clinical assets spun-out of Adare Pharmaceuticals Announcement follows TPG Capital’s sale of Adare Pharmaceuticals’ specialty CDMO pharmaceutical technology and microbiome businesses SAN FRANCISCO & FORT WORTH, Texas–(BUSINESS WIRE)–TPG Capital, … Continue reading → Business Wire MORE
Giebel as Chairman to support its novel vaccine platform through accelerated clinical development SpyBiotech raises $32.5M SpyBiotech raises $32.5M in Series A funding and appoints Lutz B. in Series A funding and appoints Lutz B. Giebel as Chairman to support … Continue reading → GlobeNewswire MORE
AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. Their lead programme ATX01 is in clinical development in Chemotherapy-Induced Peripheral Neuropathy. 15, 2020 07:15 UTC. MORE
Clinical DevelopmentThe CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options. MORE
Clinical DevelopmentA veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short. MORE
Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1]. Our highly experienced teams in Singapore and the US span antibody discovery, pharmacology, production and clinical development. MORE
Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum Tauriga Sciences Inc. Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its … Continue reading → GlobeNewswireTauriga Sciences Inc. MORE
Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance MORE
An executive from the clinical trial technology provider will share how direct data capture can save time, avoid errors and improve the patient experience. Clinical Development MORE
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterised by an inflammatory polyarthritis that preferentiallyaffects the small joints. RA is… Current features Volume 12 Issue 6 MORE
The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics. Clinical Development MORE
CAEL-101: A Fibril-reactive Monoclonal Antibody (mAb) that is Currently in Phase 3 Clinical Development – Global Emerging Insight and Market Forecasts 2020-2030 – ResearchAndMarkets.com CAEL-101: A Fibril-reactive Monoclonal Antibody (mAb) that is Currently in Phase 3 Clinical Development – Global … Continue reading → Business Wire MORE
LONDON & CHICAGO–(BUSINESS WIRE)–#advisoryboard–Anova Enterprises, Inc. MORE
Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Interim durability data from NIH-led Phase 1 study of mRNA-1273 published as … Continue reading → Business Wire MORE
Clinical DevelopmentA leader from the risk-based quality management solutions provider will discuss the growing interest in the technology, during this yearâs SCOPE event. MORE
The partnership reportedly will center on optimizing integration for EHR data and remote-source data review to help accelerate clinical research results. Clinical Development MORE
DGAP-News: Evotec SE / Key word(s): Miscellaneous 28.01.2021 / 07:30 The issuer is solely responsible for the content of this announcement. FIRST DOSE OF EVT894, A MONOCLONAL ANTIBODY AGAINST CHIKUNGUNYA VIRUS ADMINISTERED TO A HEALTHY PARTICIPANT IN A PHASE I … Continue reading → EQS Newsfeed MORE
Health Decisions and OncoBay Clinical will collaborate on specialized clinical development services addressing therapies for womenâs cancers. Clinical Development MORE
Clinical Development Related Topics Bio Pharma Dive
FEBRUARY 1, 2021
Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance
Journal for Clinical Studies
DECEMBER 8, 2020
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterised by an inflammatory polyarthritis that preferentiallyaffects the small joints. RA is… Current features Volume 12 Issue 6
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BioTech 365
FEBRUARY 24, 2021
BioTech 365
DECEMBER 15, 2020
The Pharma Data
NOVEMBER 30, 2020
Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.
The Pharma Data
DECEMBER 14, 2020
AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. Their lead programme ATX01 is in clinical development in Chemotherapy-Induced Peripheral Neuropathy. 15, 2020 07:15 UTC.
BioPharma Reporter
MARCH 3, 2021
The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.
BioTech 365
DECEMBER 3, 2020
Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Interim durability data from NIH-led Phase 1 study of mRNA-1273 published as … Continue reading → Business Wire
BioTech 365
SEPTEMBER 30, 2020
Press Release 30 September 2020 Immunicum AB Announces Update on Corporate and Clinical Development Strategy Immunicum AB (publ: IMMU.ST) announced today an update on the Company’s corporate and clinical development strategy. The strategy will be presented by members of the … Continue reading → GlobeNewswire
The Pharma Data
SEPTEMBER 22, 2020
Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities.
BioPharma Reporter
MARCH 3, 2021
Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.
BioTech 365
NOVEMBER 18, 2020
Million Placement to Accelerate and Broaden its Clinical Development Immutep Completes a A$29.6 Million Placement to Accelerate and Broaden its Clinical Development Sydney, Australia, Nov. Immutep Completes a A$29.6 19, 2020 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) … Continue reading → GlobeNewswire
BioTech 365
OCTOBER 27, 2020
5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K. Study expanded to 15,000 participants Full enrollment expected by end of November Event-driven interim data expected as soon as early first quarter 2021 U.S. pivotal Phase … Continue reading → GlobeNewswire
BioTech 365
SEPTEMBER 23, 2020
Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (IT) formulation in older patients with SMA to further support registration Basel, September 23, 2020 – Novartis Gene Therapies recently received feedback from the US … Continue reading → GlobeNewswire
BioTech 365
DECEMBER 10, 2020
STALICLA Translates its Novel Precision Medicine Approach for Autism Spectrum Disorder into Clinical Development with First Patient in Phase 1b Trial of STP1 STALICLA Translates its Novel Precision Medicine Approach for Autism Spectrum Disorder into Clinical Development with First Patient … Continue reading → Business Wire
BioTech 365
JANUARY 28, 2021
DGAP-News: Evotec SE / Key word(s): Miscellaneous 28.01.2021 / 07:30 The issuer is solely responsible for the content of this announcement. FIRST DOSE OF EVT894, A MONOCLONAL ANTIBODY AGAINST CHIKUNGUNYA VIRUS ADMINISTERED TO A HEALTHY PARTICIPANT IN A PHASE I … Continue reading → EQS Newsfeed
Outsourcing Pharma
FEBRUARY 4, 2021
Clinical DevelopmentThe founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach.
BioTech 365
OCTOBER 15, 2020
GHENT, Belgium–(BUSINESS WIRE)–Confo Therapeutics today announced the selection of its first preclinical drug candidate, CFTX-1554, a compound designed to address peripheral neuropathic pain with the potential to address additional pain indications.
BioTech 365
FEBRUARY 10, 2021
Giebel as Chairman to support its novel vaccine platform through accelerated clinical development SpyBiotech raises $32.5M SpyBiotech raises $32.5M in Series A funding and appoints Lutz B. in Series A funding and appoints Lutz B. Giebel as Chairman to support … Continue reading → GlobeNewswire
BioTech 365
JANUARY 6, 2021
CAEL-101: A Fibril-reactive Monoclonal Antibody (mAb) that is Currently in Phase 3 Clinical Development – Global Emerging Insight and Market Forecasts 2020-2030 – ResearchAndMarkets.com CAEL-101: A Fibril-reactive Monoclonal Antibody (mAb) that is Currently in Phase 3 Clinical Development – Global … Continue reading → Business Wire
Outsourcing Pharma
DECEMBER 10, 2020
Health Decisions and OncoBay Clinical will collaborate on specialized clinical development services addressing therapies for womenâs cancers. Clinical Development
BioTech 365
DECEMBER 18, 2020
Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum Tauriga Sciences Inc. Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its … Continue reading → GlobeNewswireTauriga Sciences Inc.
Outsourcing Pharma
FEBRUARY 16, 2021
Clinical DevelopmentA study by two trial technology firms reportedly indicates that decentralized trials are outperforming on-site in recruitment, retention and other aspects.
The Pharma Data
NOVEMBER 29, 2020
Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. Prior to joining industry, she was clinical professor at NYU Langone Medical Center and director of Hepatology at NYU Plainview, NY. SHANGHAI , Nov.
Outsourcing Pharma
OCTOBER 19, 2020
Clinical DevelopmentThe agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.
Outsourcing Pharma
JANUARY 18, 2021
Clinical DevelopmentA leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.
BioTech 365
OCTOBER 29, 2020
Enables compliant, timely surveillance and outcomes research to help get safe and effective therapies to patients faster NEW YORK & CAMBRIDGE, Mass. & & SAN FRANCISCO–(BUSINESS WIRE)–Medidata, a Dassault Systèmes company, TriNetX, and Datavant announced a partnership that will accelerate the … Continue reading → Business Wire
Outsourcing Pharma
MARCH 2, 2021
Clinical DevelopmentAccording to Noxopharm, a recent study shows combining its Veyonda drug and a radiopharmaceutical yields favorable results against prostate cancer.
Outsourcing Pharma
MARCH 2, 2021
The Verisense Pulse+ can measure heart rate, oxygen saturation, emotional responses, and activity and sleep levels of at-home clinical trial participants. Clinical Development
Outsourcing Pharma
MARCH 4, 2021
Clinical DevelopmentThe CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.
Outsourcing Pharma
OCTOBER 8, 2020
Clinical DevelopmentA veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.
Outsourcing Pharma
JANUARY 25, 2021
Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges. Clinical Development
Outsourcing Pharma
AUGUST 11, 2020
Clinical DevelopmentAmerican Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.
BioTech 365
OCTOBER 7, 2020
LONDON & CHICAGO–(BUSINESS WIRE)–#advisoryboard–Anova Enterprises, Inc.
BioTech 365
SEPTEMBER 22, 2020
TPG Capital establishes new entity to continue the development of select clinical assets spun-out of Adare Pharmaceuticals Announcement follows TPG Capital’s sale of Adare Pharmaceuticals’ specialty CDMO pharmaceutical technology and microbiome businesses SAN FRANCISCO & FORT WORTH, Texas–(BUSINESS WIRE)–TPG Capital, … Continue reading → Business Wire
Outsourcing Pharma
FEBRUARY 1, 2021
Clinical DevelopmentBioclinicaâs Image Redact AI tool enables trials to edit sensitive information from videos, photos and PDFs to ensure compliance and safeguard patient data.
Outsourcing Pharma
MARCH 2, 2021
Clinical DevelopmentA leader from Vocalis Health explains how health data can be culled from patient voice recordings to screen and monitor COVID-19 and other conditions.
The Pharma Data
DECEMBER 13, 2020
Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1]. Our highly experienced teams in Singapore and the US span antibody discovery, pharmacology, production and clinical development.
Outsourcing Pharma
FEBRUARY 25, 2021
Clinical DevelopmentA leader from the risk-based quality management solutions provider will discuss the growing interest in the technology, during this yearâs SCOPE event.
Outsourcing Pharma
MARCH 1, 2021
The partnership reportedly will center on optimizing integration for EHR data and remote-source data review to help accelerate clinical research results. Clinical Development
Outsourcing Pharma
FEBRUARY 24, 2021
The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics. Clinical Development
Outsourcing Pharma
FEBRUARY 24, 2021
An executive from the clinical trial technology provider will share how direct data capture can save time, avoid errors and improve the patient experience. Clinical Development
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