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

Bias in artificial intelligence impacts drug development: AiCure

Outsourcing Pharma

According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments. Clinical Development

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

The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

CATO Research

Hence, the next clinical milestone will very likely be the development of allogeneic CART therapies that could offer off-the-shelf products with immediate availability as an on-demand therapeutic option for patients with high unmet medical needs. Meeting Clinical Objectives.

Taysha Gene Therapies Announces Initiation of Clinical Development of TSHA-118 for the Treatment of CLN1 Disease

BioTech 365

Taysha Gene Therapies Announces Initiation of Clinical Development of TSHA-118 for the Treatment of CLN1 Disease Taysha Gene Therapies Announces Initiation of Clinical Development of TSHA-118 for the Treatment of CLN1 Disease CTA approved by Health Canada in November 2021; … Continue reading → Business Wire

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.

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

BioTech 365

Zynerba Pharmaceuticals Announces Clinical Development Updates for FXS, ASD, 22q and DEE

BioTech 365

Zynerba Pharmaceuticals Announces Clinical Development Updates for FXS, ASD, 22q and DEE Zynerba Pharmaceuticals Announces Clinical Development Updates for FXS, ASD, 22q and DEE – Company plans to focus development of Zygel™ in FXS, ASD and 22q – – Company … Continue reading → GlobeNewswire

Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205

BioTech 365

Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205 Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205 Response to pre-IND briefing package supports pathway to initiating a Phase 1 … Continue reading → GlobeNewswire

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.

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

BioTech 365

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

BioTech 365

Nicox Appoints Doug Hubatsch as new Chief Scientific Officer to lead Clinical and Non-clinical Development

BioTech 365

Nicox Appoints Doug Hubatsch as new Chief Scientific Officer to lead Clinical and Non-clinical Development Nicox Appoints Doug Hubatsch as new Chief Scientific Officer to lead Clinical and Non-clinical Development Press Release Nicox Appoints Doug Hubatsch as new Chief Scientific … Continue reading → GlobeNewswire

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

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

Taysha Gene Therapies Announces Positive Initial Biomarker Data For TSHA-101, the First Bicistronic Gene Therapy in Clinical Development, Demonstrating Normalization of β-Hexosaminidase A Enzyme Activity in Patients With GM2 Gangliosidosis

BioTech 365

Taysha Gene Therapies Announces Positive Initial Biomarker Data For TSHA-101, the First Bicistronic Gene Therapy in Clinical Development, Demonstrating Normalization of ?-Hexosaminidase

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.,

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.

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments

BioTech 365

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared … Continue reading → GlobeNewswire

Inflammasome develops combo HIV/birth control implant

Outsourcing Pharma

Clinical DevelopmentThanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.

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.,

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

BioTech 365

Stand Up to Cancer research initiative targets pancreatic cancer

Outsourcing Pharma

Clinical DevelopmentJoining with a noted research foundation, the group is aiming for earlier detection and treatment of the disease, which hits nearly 500K people annually.

FDA approves IND for clinical trial evaluating CBD-based drug

Outsourcing Pharma

Clinical DevelopmentThe agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

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

BioTech 365

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.

Adrenomed Receives Positive EMA Scientific Advice for Further Clinical Development of Adrecizumab in Septic Shock

BioTech 365

Press Release Adrenomed Receives Positive EMA Scientific Advice for Further Clinical Development of Adrecizumab in Septic Shock Positive EMA … Continue reading → EQS NewsfeedDGAP-News: Adrenomed AG / Key word(s): Miscellaneous 02.12.2021 / 11:30 The issuer is solely responsible for the content of this announcement.

Memo Therapeutics AG to Receive CHF 10.5 Million from Swiss Federal Funding Programme to Clinically Develop SARS-CoV-2 Antibody Against COVID-19

BioTech 365

Million from Swiss Federal Funding Programme to Clinically Develop SARS-CoV-2 Antibody Against COVID-19 Memo Therapeutics AG to Receive CHF 10.5 Memo Therapeutics AG to Receive CHF 10.5

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

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

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

BioTech 365

Michael J. Fox Foundation significantly expands Parkinson’s study

BioPharma Reporter

Clinical DevelopmentThe Parkinsonâs Progression Markers Initiative, built using Evidation Healthâs research platform, aims to triple enrollment and recruit online participants.

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

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

BioTech 365

International experts develop Clinical Care Pathway in response to NASH epidemic

Scienmag

Biology care clinical develop epidemic Experts international NASH pathway response

Insilico Medicine launches trial for AI-discovered drug

Outsourcing Pharma

Clinical DevelopmentThe artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

NervGen Pharma sets sights on trial for spinal-cord injury treatment

Outsourcing Pharma

Clinical DevelopmentThe company plans to launch a Phase Ib/II study of its compound NVG-291 in collaboration with researchers at Northwestern Universityâs Shirley Ryan AbilityLab.