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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Brii Biosciences Provides Update on Strategic Clinical Development Progress

BioTech 365

Brii Biosciences Provides Update on Strategic Clinical Development Progress Brii Biosciences Provides Update on Strategic Clinical Development Progress Company received U.S.

Fractyl Announces Closing of $100 Million Series F Financing to Expand Clinical Development Programs in Type 2 Diabetes

BioTech 365

Fractyl Announces Closing of $100 Million Series F Financing to Expand Clinical Development Programs in Type 2 Diabetes Fractyl Announces Closing of $100 Million Series F Financing to Expand Clinical Development Programs in Type 2 Diabetes – Financing will support … Continue reading → Business Wire

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

BioTech 365

Modra Pharmaceuticals Appoints Two New Supervisory Board Members Adding Significant Experience in Corporate and Clinical Development

BioTech 365

Komodo Health Announces Agreement to Accelerate Clinical Development with Real-World Patient Data and Software

BioTech 365

ESCAPE Bio Snags $73 Million to Advance Neurodegenerative Clinical Development Programs

BioSpace

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

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

BioTech 365

Tubulis appoints Günter Fingerle-Rowson as Chief Medical Officer to lead the clinical development of its new generation of ADCs

BioTech 365

Tubulis appoints Günter Fingerle-Rowson as Chief Medical Officer to lead the clinical development of its new generation of ADCs Tubulis appoints Günter Fingerle-Rowson as Chief Medical Officer to lead the clinical development of its new generation of ADCs MUNICH–(BUSINESS WIRE)–Tubulis … 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

Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA

BioTech 365

Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA PRESS RELEASE April 22, 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused … Continue reading → GlobeNewswire

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

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.

Core One Labs to Explore Joint Venture with Lobe Sciences for the Clinical Development of Biosynthetic Psilocybin

BioTech 365

Core One Labs to Explore Joint Venture with Lobe Sciences for the Clinical Development of Biosynthetic Psilocybin Core One Labs to Explore Joint Venture with Lobe Sciences for the Clinical Development of Biosynthetic Psilocybin VANCOUVER, British Columbia, April 28, 2021 … Continue reading → GlobeNewswire

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.

Confo Therapeutics Awarded EUR 1M VLAIO Grant for Pre-Clinical Development of CFTX-1554, an AT2R Modulator for the Treatment of Neuropathic Pain

BioTech 365

Confo Therapeutics Awarded EUR 1M VLAIO Grant for Pre-Clinical Development of CFTX-1554, an AT2R Modulator for the Treatment of Neuropathic Pain Confo Therapeutics Awarded EUR 1M VLAIO Grant for Pre-Clinical Development of CFTX-1554, an AT2R Modulator for the Treatment of … Continue reading → Business Wire

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

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.

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

Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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.

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 enters partnership with Kazia Therapeutics for clinical development of EVT801

BioTech 365

EVOTEC GRANTS KAZIA THERAPEUTICS AN EXCLUSIVE WORLDWIDE LICENSE FOR DEVELOPMENT AND COMMERCIALISATION OF ONCOLOGY ASSET EVT801 KAZIA INTENDS TO … Continue reading → EQS NewsfeedDGAP-News: Evotec SE / Key word(s): Miscellaneous 19.04.2021 / 08:31 The issuer is solely responsible for the content of this announcement.

AI algorithm automates analysis of cystic fibrosis scans

Outsourcing Pharma

Clinical DevelopmentArtificial intelligence software company Thirona has released PRAGMA-AI, technology that automates and accelerates CT scans in cystic fibrosis analysis.

Canine cancer research startup impacts treatment in humans

Outsourcing Pharma

One Healthâs FidoCure is using genomics and AI technology to develop precision oncological treatments, and the work is benefiting human cancer research. Clinical Development

Study solutions take center stage at DIA 2021 Annual Meeting

BioPharma Reporter

These organizations hope to connect with attendees at the event, sharing clinical research ideas and innovations in sessions and the virtual exhibit hall. Clinical Development

CVS Health broadens commitment to improving clinical trial infrastructure

Outsourcing Pharma

Clinical DevelopmentThe owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem.

Dive into advanced data, ethical issues at free online event

Outsourcing Pharma

The April 6 webinar, Clinical Development Innovations, will touch upon artificial intelligence, machine learning, ethics and other impactful issues. Clinical Development

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.

Drugs 52

Australia, NZ appealing to clinical researchers: Greenphire

BioPharma Reporter

Clinical DevelopmentThanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.

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

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.

Cancer Moonshot partnership hones in on digital biomarkers

Outsourcing Pharma

Medable will collaborate with Aural Analytics in an initiative funded by the NIHâs seven-year Beau Biden Cancer Moonshot research and development program. Clinical Development

Partnership delivers research, care to diverse communities

Outsourcing Pharma

Elligo Health Research is joining forces with Laguna Clinical research Associates to expand access to clinical care to a broader range of patient populations. Clinical Development

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.

Study examines solution to gauge adverse drug event risk

Outsourcing Pharma

Clinical DevelopmentPublished by Tabula Rasa Healthcare, the report looks at the MedWise Risk Score, technology designed to determine ADE risk rising from medication regimens.

PPD, Clinical Ink join on lupus assessment and endpoint data

Outsourcing Pharma

The two companies have partnered to develop a systemic erythematosus assessment review to streamline clinical trials centered on the autoimmune disease. Clinical Development

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

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

AstraZeneca taps Reify Health platform to boost breast cancer trials

Outsourcing Pharma

The pharma firm plans to use the StudyTeam platform to accelerate development, ease site burdens and improve patient matching for breast cancer studies. Clinical Development