Drug Development

Research into Cold Cancers Heating Up

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Development of Gamma-Delta T-Cell Therapies

Activation and expansion are essential for success in both autologous and allogeneic therapies.

QbD for Small-Molecule Continuous Process Development

Continuous manufacturing and a quality-by-design development approach are a natural fit.

Sanofi and Janssen Sign Agreement for Phase III Extraintestinal Pathogenic E. coli Vaccine Candidate

October 09, 2023

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.

Webcasts

mRNA Discovery Strategy Framework to Set You Up for Manufacturing Success

October 09, 2023

Webinar Date/Time: Thu, Oct 26, 2023 11:00 AM EDT

NIH Awards $45.1 Million Grant for ALS Treatment

October 05, 2023

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

FDA Establishes Pilot Program to Accelerate Rare Disease Therapy Development

October 05, 2023

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19

October 04, 2023

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

Pfizer and Ginkgo Bioworks to Collaborate on Multi-Target RNA Discovery

October 04, 2023

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

October 02, 2023

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Webcasts

Nitrosamines, Elemental Impurities, Extractables and Leachables: A New Normal for the Pharma Industry

October 02, 2023

Webinar Date/Time: Tuesday, October 17, 2023 at 11am EDT | 4pm BST | 5pm CEST

Webcasts

The Importance of Holistic Sterile Drug Product Development

September 29, 2023

Webinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT

Driving Dosage Form Developments

September 29, 2023

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.