Development

BARDA, DOD Award $450-Million COVID-19 Manufacturing and Supply Contract to Regeneron

July 08, 2020

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

SGS Initiates Clinical Trial of Biophytis’ Treatment for COVID-19 Related Respiratory Failure

July 08, 2020

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

European Commission Approves Lynparza for BRCA-Mutated Metastatic Pancreatic Cancer

July 08, 2020

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

GSK, Medicago Collaborate on Covid-19 Vaccine Candidate

July 08, 2020

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

July 07, 2020

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Intravacc, CimCure Partner to Develop COVID-19 Vaccine

July 02, 2020

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

Can Using RNA Simplify Gene Therapy Development?

July 01, 2020

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Navigating Uncharted Waters

July 01, 2020

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

FDA Gives Guidance on Development of COVID-19 Vaccines

June 30, 2020

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

ILC Therapeutics Enters Research Agreement with University of St Andrews

June 25, 2020

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.