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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Adverum Down After Clinical Development Shift for Gene Therapy Program

BioSpace

Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME

Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant

BioTech 365

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.

Alzheon Appoints Adem Albayrak as Head of Operations and Earvin Liang, PhD, as Vice President of Clinical Development

BioTech 365

Alzheon Appoints Adem Albayrak as Head of Operations and Earvin Liang, PhD, as Vice President of Clinical Development Alzheon Appoints Adem Albayrak as Head of Operations and Earvin Liang, PhD, as Vice President of Clinical Development New Hires Bring Extensive … Continue reading → Business Wire

Equillium Reports Second Quarter 2021 Financial Results and Provides Clinical Development Update

BioTech 365

Prokarium Appoints Uz Stammberger as Chief Medical Officer to Drive Clinical Development in Oncology

BioTech 365

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

BioTech 365

Lung Therapeutics Announces Appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development

BioTech 365

Lung Therapeutics Announces Appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development Lung Therapeutics Announces Appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development Key leadership appointment of Dr. Morriss enhances the company’s research … Continue reading → Business Wire

SQZ Biotechnologies Strengthens Board with Global Commercial and Clinical Development Experience

BioTech 365

SQZ Biotechnologies Strengthens Board with Global Commercial and Clinical Development Experience SQZ Biotechnologies Strengthens Board with Global Commercial and Clinical Development Experience Bernard Coulie, M.D.,

PulmoSIM Therapeutics Announces Strategic Partnership with Top Respiratory Hospitals to Initiate Clinical Development of PT001 to Treat Pulmonary Arterial Hypertension

BioTech 365

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

BioTech 365

Anticancer Bioscience Appoints Leader in Oncology Drug Development, Dr. Hong Liu, as US-based VP of Clinical Development

BioTech 365

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

BioTech 365

Allarity Therapeutics and Lantern Pharma Enter into Agreement for Future Clinical Development of Irofulven

BioTech 365

Allarity Therapeutics and Lantern Pharma Enter into Agreement for Future Clinical Development of Irofulven Allarity Therapeutics and Lantern Pharma Enter into Agreement for Future Clinical Development of Irofulven Lantern will reacquire global rights to Irofulven and assume full authority to … Continue reading → GlobeNewswire

TFS HealthScience Standardizes on Veeva Vault Clinical Operations Suite to Accelerate Clinical Development

BioTech 365

Medsenic Partners With Phebra for the Clinical Development of the Oral Form of Arscimed® for the Treatment of Autoimmune Diseases

BioTech 365

Medsenic Partners With Phebra for the Clinical Development of the Oral Form of Arscimed® for the Treatment of Autoimmune Diseases Medsenic Partners With Phebra for the Clinical Development of the Oral Form of Arscimed® for the Treatment of Autoimmune Diseases … Continue reading → Business Wire

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

BioTech 365

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

EpiEndo Pharmaceuticals Secures EUR 20 Million Series A Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for the treatment of COPD

BioTech 365

EpiEndo Pharmaceuticals Secures EUR 20 Million Series A Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for the treatment of COPD EpiEndo Pharmaceuticals Secures EUR 20 Million Series A Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for … Continue reading → Business Wire

ObsEva To Present Data on Two Clinical Development Programs at ESHRE Virtual 37th Annual Meeting

BioTech 365

ObsEva To Present Data on Two Clinical Development Programs at ESHRE Virtual 37th Annual Meeting ObsEva To Present Data on Two Clinical Development Programs at ESHRE Virtual 37th Annual Meeting – Data from Phase 3 study of Yselty® (linzagolix) … Continue reading → GlobeNewswire

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

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

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 Move Its Psychedelic Formulations for the Treatment of Stroke and Depression Toward Clinical Development

BioTech 365

Core One Labs to Move Its Psychedelic Formulations for the Treatment of Stroke and Depression Toward Clinical Development Core One Labs to Move Its Psychedelic Formulations for the Treatment of Stroke and Depression Toward Clinical Development VANCOUVER, British Columbia, Aug.

Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury

Pharma Mirror

The post Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury appeared first on Pharma Mirror Magazine.

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

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

Treg cell therapy showing promise in ALS trials: Coya Therapeutics

BioPharma Reporter

Clinical DevelopmentAccording to the neurodegenerative-disease-focused biotechnology firm, their research could bring hope to patients with amyotrophic lateral sclerosis.

BMS joins with Black colleges to increase pharma talent diversity

BioPharma Reporter

Clinical DevelopmentThe pharma firm is working with five US colleges and universities onto create programming designed to boost recruitment of Black talent in the industry.

Psychedelics research institute launches in Australia

Outsourcing Pharma

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development. Clinical Development

ACD/Labs, Science Data Experts establish AI partnership

Outsourcing Pharma

Clinical DevelopmentThe two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.

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.

Prepping for success can streamline transition to decentralized trials: Oracle

Outsourcing Pharma

Clinical DevelopmentAccording to an Oracle Health Sciences leader, companies looking to take on decentralized trials should keep a few things in mind before taking the plunge.