Pharmacovigilance – Products

The 7th CSP Blind Test will see the methods in Crystal Structure Prediction put to the test on real targets. The 7 test systems have been sourced from leading experimentalists in industry and academia for prediction.

Download this app note to discover more about binding parameters and high-throughput assays in drug development.

Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the European Medicines Agency (EMA) Orphan Drug Commission (COMP) has granted a positive opinion for an Orphan Drug Designation (ODD) status to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.

Impel NeuroPharma announced that it has presented patient-reported outcomes data from the Company’s pivotal Phase 3, open-label study “STOP 301” of INP104 (dihydroergotamine mesylate) or DHE using the company’s proprietary POD technology, for the treatment of acute migraine in an oral presentation at the Migraine Trust Virtual Symposium (MTIS) to be held from October 3-9, 2020.

PerkinElmer, announced that the PerkinElmer Signals™ Notebook and PerkinElmer Signals™ Medical Review SaaS solutions have been granted SOC 2 Level 1 Attestation for the American Institute of Certified Public Accountants (AICPA’s) Trust Service Principles of Security, Confidentiality and Availability. With the SOC 2 attestations, biotech and pharmaceutical companies have the added assurance that the PerkinElmer Signals solutions have been designed with intellectual property protection in mind.

A common topic amongst biopharmaceutical companies is data quality and data integrity; high data quality and integrity is critical to ensure patient safety and drug efficacy from research and development through to manufacturing. This whitepaper examines data integrity at every stage of the drug development process.

Regeneron has announced the first data from a descriptive analysis of a Phase 1/2/3 trial of the investigational antibody cocktail known as "REGN-COV2". Results show that it reduced viral load and alleviated symptoms in non-hospitalized patients with COVID-19.

Johnson & Johnson today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.

OXGENE™, a biotechnology company designing and developing scalable gene therapy technologies, has today announced the launch of its scalable, plasmid-free manufacturing system for AAV. OXGENE’s new TESSA™ technology addresses industry-wide challenges associated with robust and reproducible AAV manufacture at scale. These include high cost of goods, and low packaging efficiency. TESSA aims to deliver a paradigm shift in scalable AAV manufacture.