Search Results for: CLINICAL TRIALS Its Time to
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FORMULATION FORUM - Considerations in Formulation Development of Injectable Solutions May 3, 2021
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
EXECUTIVE INTERVIEW - Micropore: Innovation in Drug Delivery May 3, 2021
Dai Hayward, CEO at Micropore, discusses his company’s expertise and underpinning technology in the development of safe, efficient, and scalable continuous manufacturing of drug delivery solutions.
INJECTABLES MANUFACTURING - Manufacturing Injectable Devices: Why Modern Means Modular May 3, 2021
Raffaele Pace, MMe, MBA, reviews how today’s drug delivery devices must be more mobile, less intrusive, and simpler than ever before – all while remaining cost competitive.
AavantiBio & Catalent Announce Partnership to Support Development & Manufacturing of Gene Therapies April 29, 2021
AavantiBio and Catalent recently announced a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA)….
Brickell Biotech Completes Patient Enrollment in US Phase 3 Pivotal Cardigan I Study April 29, 2021
Brickell Biotech, Inc. recently announced completion of patient enrollment in the Phase 3 pivotal Cardigan I study and that the...CureVac Swiss AG Initiates Rolling Submission Process for mRNA-Based COVID-19 Vaccine Candidate April 21, 2021
The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. recently announced initiation of a rolling submission for CVnCoV, the company’s mRNA-based COVID-19 vaccine….
New Biomaterial Regrows Blood Vessels & Bone According to RCSI Research April 21, 2021
Scientists have developed a new biomaterial that regrows blood vessels and bone, potentially providing a single-stage approach when repairing large...New England Journal of Medicine Publishes Results of the PULSAR Phase 2 Trial of Sotatercept in Patients With Pulmonary Arterial Hypertension April 8, 2021
Acceleron Pharma Inc. recently announced the New England Journal of Medicine has published results of the PULSAR Phase 2 trial of...BridgeBio Pharma’s Affiliate QED Therapeutics & Helsinn Group Announce Strategic Co-Development & Commercialization Agreement April 1, 2021
BridgeBio Pharma, Inc., through its affiliate QED Therapeutics, Inc., and Helsinn Group recently announced a global collaboration and licensing agreement...Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents April 1, 2021
Pfizer Inc. and BioNTech SE recently announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2….
EXECUTIVE INTERVIEW - Celanese: Better Therapeutic Outcomes From Better Drug Delivery March 29, 2021
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
AstraZeneca’s & J&J’s COVID-19 Vaccines Manufacturing Face Viral Vector Shortages March 25, 2021
The latest wave of COVID-19 vaccines - those from AstraZeneca and Johnson & Johnson (J&J) - are recombinant vector vaccines,...Ocuphire Announces Publication of MIRA-1 Phase 2b Results Demonstrating Reduction of Pharmacologically Induced Mydriasis March 10, 2021
Ocuphire Pharma recently announced that the results from the MIRA-1 (NCT04024891) Phase 2b clinical trial evaluating the safety and efficacy...FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies March 1, 2021
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
CELL & GENE THERAPY - End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build? March 1, 2021
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
DRUG DEVELOPMENT - Understanding & Targeting the Mechanism of Action of Developmental Disorders March 1, 2021
Michael Snape, PhD, says when identifying promising therapeutic targets for any disease or condition, including developmental disorders such as Fragile X syndrome, PMS, CDM1, and Rett syndrome, it is critical researchers work to understand the mechanism of disease and disease pathways as well as the unmet need and patient experience.
IMMUNE ACTIVATORS - Enhancing Cell Adhesion to Safely Improve Effectiveness of Vaccines & Cancer Immunotherapies March 1, 2021
Siddhartha De, PhD, and Peter Vanderslice, PhD, present their research on the use of proprietary, orally available compounds that can activate the immune system to enhance the effectiveness of vaccines as well as immuno-oncology therapies for cancer, especially in patient populations that are most vulnerable to disease.
EXECUTIVE INTERVIEW - Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization March 1, 2021
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
Mateon Therapeutics & Windlas Biotech Launch India's First Combined Lung Therapy & AI Telemedicine Solution February 24, 2021
Mateon Therapeutics, Inc. and Windlas Biotech Pvt. Ltd. recently announced the launch in India of PulmoHeal, a first-of-its-kind integrated, consumer-centric...Leveraging Medical Laboratory Data for Patient Recruitment February 24, 2021
Cerba Research recently announced a new partnership with Biokortex, a provider of digital solutions to the healthcare sector. This partnership...
