Navigating the challenges of proper fill and finish in clinical development

Bio Pharma Dive

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

Clinical Development in Inflammatory Diseases: Rheumatoid Arthritis

Journal for Clinical Studies

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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EpiEndo Pharmaceuticals Appoints Maria Bech as New Chief Executive Officer to Support Move into Clinical Development

BioTech 365

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

BioTech 365

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

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.

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

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.

Report extols virtues of UK for the clinical development of ATMPs

BioPharma Reporter

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.

Edgewise Therapeutics Completes $95 Million Series C Financing to Advance Clinical Development of Muscular Dystrophy Program

BioTech 365

Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate

BioTech 365

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

Immunicum AB Announces Update on Corporate and Clinical Development Strategy

BioTech 365

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

Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

The Pharma Data

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.

Industry review: Regulatory harmonization would enable robust and timely clinical development of vaccines

BioPharma Reporter

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.

Immutep Completes a A$29.6 Million Placement to Accelerate and Broaden its Clinical Development

BioTech 365

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

Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update

BioTech 365

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

Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

BioTech 365

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

STALICLA Translates its Novel Precision Medicine Approach for Autism Spectrum Disorder into Clinical Development with First Patient in Phase 1b Trial of STP1

BioTech 365

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

Evotec Starts Clinical Development of Chikungunya Antibody together with NIAID and Leading Academic Research Organisation

BioTech 365

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

Family cancer experience informs eHealth company

Outsourcing Pharma

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.

Confo Therapeutics Announces Selection of First Product Candidate and Initiation of Pre-Clinical Development

BioTech 365

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.

SpyBiotech raises $32.5M in Series A funding and appoints Lutz B. Giebel as Chairman to support its novel vaccine platform through accelerated clinical development

BioTech 365

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

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

BioTech 365

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

CROs partner on women’s oncology clinical solutions

Outsourcing Pharma

Health Decisions and OncoBay Clinical will collaborate on specialized clinical development services addressing therapies for womenâs cancers. Clinical Development

Tauriga Sciences Inc. Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum

BioTech 365

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.

Decentralized trials more pandemic-proof than traditional: study

Outsourcing Pharma

Clinical DevelopmentA study by two trial technology firms reportedly indicates that decentralized trials are outperforming on-site in recruitment, retention and other aspects.

Gannex Appoints Former Takeda Head of Liver Disease Clinical Development Melissa Palmer, MD as Chief Medical Officer

The Pharma Data

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.

WHO: remdesivir shows little effect on COVID-19

Outsourcing Pharma

Clinical DevelopmentThe agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.

Trials 111

COVID-19 a ‘catalyst’ for innovation in 2020: Oracle

Outsourcing Pharma

Clinical DevelopmentA leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.

Medidata, TriNetX, and Datavant Partner to Enable Seamless Integration of Real-World Data in Clinical Development

BioTech 365

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

Prostate cancer drug demonstrates major survival benefit

Outsourcing Pharma

Clinical DevelopmentAccording to Noxopharm, a recent study shows combining its Veyonda drug and a radiopharmaceutical yields favorable results against prostate cancer.

Drugs 56

Shimmer launches upgraded wearable for remote patient monitoring

Outsourcing Pharma

The Verisense Pulse+ can measure heart rate, oxygen saturation, emotional responses, and activity and sleep levels of at-home clinical trial participants. Clinical Development

US Army taps PPD to conduct PTSD treatment research

Outsourcing Pharma

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.

Clinical trials have ‘much work to do’ in boosting diversity

Outsourcing Pharma

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.

eCOA tech helps trials tackle COVID-19 obstacles: IQVIA

Outsourcing Pharma

Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges. Clinical Development

Potential HIV cure Phase I trial gets FDA green light

Outsourcing Pharma

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.

Gene 114

Anova Announces Formation of Scientific Advisory Board to Advance Development of Its Technology Platform Transforming Clinical Development

BioTech 365

LONDON & CHICAGO–(BUSINESS WIRE)–#advisoryboard–Anova Enterprises, Inc.

TPG Forms Ellodi Pharmaceuticals to Continue Clinical Development of APT-1011 for Treatment of Eosinophilic Esophagitis

BioTech 365

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

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AI-based image redaction guards trial patient privacy

Outsourcing Pharma

Clinical DevelopmentBioclinicaâs Image Redact AI tool enables trials to edit sensitive information from videos, photos and PDFs to ensure compliance and safeguard patient data.

Vocal biomarkers enable unique diagnosis, monitoring capabilities

Outsourcing Pharma

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.

Hummingbird Bioscience Announces Collaboration with Tempus to Harness AI-driven Precision Medicine to Accelerate Clinical Development of HMBD-001 In HER3 Driven Cancers

The Pharma Data

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.

COVID-19 elevates appreciation, use of RBQM: CluePoints

Outsourcing Pharma

Clinical DevelopmentA leader from the risk-based quality management solutions provider will discuss the growing interest in the technology, during this yearâs SCOPE event.

Syneos, Protocol First to collaborate on trial data solutions

Outsourcing Pharma

The partnership reportedly will center on optimizing integration for EHR data and remote-source data review to help accelerate clinical research results. Clinical Development

SCOPE 2021 to take on tough clinical trial challenges

Outsourcing Pharma

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

Drugs 56

Direct data capture a 'game changer' for trials: Clinical Ink

Outsourcing Pharma

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