News

Gamesmanship Escalates over FDA User Fee Legislation

July 18, 2022

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

Royalty Pharma Acquires Royalty Rights to COPD/Asthma Treatment for $1.6 Billion

July 18, 2022

Royalty Pharma is paying $1.6 billion for the royalty rights to Trelegy Ellipta, a treatment for COPD and asthma.

FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted

July 18, 2022

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

EMA Publishes Guidance on Preventing Medicine Shortages

July 18, 2022

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.

Vertex to Acquire ViaCyte for $320 Million

July 18, 2022

Vertex’s $320 million acquisition of ViaCyte will give the company complementary capabilities for its Type 1 diabetes therapy program.

FDA Regulation of Nonprescription Drugs in Spotlight

July 14, 2022

Application for OTC contraceptive highlights efforts to broaden access to medicines.

WHO’s Science Council Calls for Equitable Expansion of Genomics

July 13, 2022

WHO’s Science Council released a report calling for a collective effort to accelerate global access to genomics.

Merck Digital Sciences Studio Supports Early-Stage Startups

July 13, 2022

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA

July 13, 2022

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center

July 12, 2022

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.