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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Samsung Biologics to help Enzolytics advance clinical development of mAbs

BioPharma Reporter

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production. Upstream Processing

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

Equillium Reports Third Quarter 2021 Financial Results and Provides Clinical Development Updates

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.

Avacta Group plc: Achievement of Pre-clinical Development Milestone in LG Chem Life Sciences Partnership

BioTech 365

ALX Oncology Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights

BioTech 365

ALX Oncology Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights ALX Oncology Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights SOUTH SAN FRANCISCO, Calif.,

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

BioTech 365

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

BioTech 365

ZS Announces Exclusive Partnership with Intelligencia to Reduce Risk in Clinical Development and Guide Portfolio Investments

BioTech 365

ZS Announces Exclusive Partnership with Intelligencia to Reduce Risk in Clinical Development and Guide Portfolio Investments ZS Announces Exclusive Partnership with Intelligencia to Reduce Risk in Clinical Development and Guide Portfolio Investments EVANSTON, Ill.–(BUSINESS

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.

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

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.,

AsclepiX appoints Dr. Amir Shojaei as Chief Scientific Officer and Executive Vice President, Clinical Development

BioTech 365

AsclepiX appoints Dr. Amir Shojaei as Chief Scientific Officer and Executive Vice President, Clinical Development AsclepiX appoints Dr. Amir Shojaei as Chief Scientific Officer and Executive Vice President, Clinical Development Shojaei brings over two and a half decades of experience in clinical pharmaceutical development BALTIMORE, Oct.

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

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

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.

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

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

BioTech 365

Valbiotis Announces That It Has Submitted to the Competent Authorities the Three Clinical Protocols for TOTUM•854 Indicated in the Reduction of Blood Pressure and Presents Its Comprehensive Clinical Development Plan

BioTech 365

Valbiotis Announces That It Has Submitted to the Competent Authorities the Three Clinical Protocols for TOTUM•854 Indicated in the Reduction of Blood Pressure and Presents Its Comprehensive Clinical Development Plan Valbiotis Announces That It Has Submitted to the Competent Authorities … Continue reading → Business Wire

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

BioTech 365

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

BioTech 365

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

BioTech 365

Potential COVID-19 treatment to wrap up Phase III trial

Outsourcing Pharma

Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma. Clinical Development

Trials 111

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

Gene-edited cell replacement therapy for diabetes set to enter the clinic

BioPharma Reporter

have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Clinical DevelopmentCRISPR Therapeutics and ViaCyte, Inc.

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

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

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

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

AB Science receives FDA authorization to start clinical development program of masitinib in mast cell activation syndrome (MCAS)

BioTech 365

AB Science receives FDA authorization to start clinical development program of masitinib in mast cell activation syndrome (MCAS) AB Science receives FDA authorization to start clinical development program of masitinib in mast cell activation syndrome (MCAS) PRESS RELEASE AB SCIENCE … Continue reading → GlobeNewswire

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

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.

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

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.

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

AstraZeneca: lupus drug candidate shows promise in Phase III trial

Outsourcing Pharma

Clinical DevelopmentAccording to the pharma firm, Saphnelo (anifrolumab) combined with standard therapy resulted in reduction of systemic lupus erythematosus disease activity.

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