News

Takeda and Novavax Team Up for COVID-19 Vaccine Development in Japan

August 11, 2020

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

FDA Publishes Guidance on Drug-Drug Interaction Studies for a Therapeutic Protein

August 11, 2020

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

Researchers Question Russia’s COVID-19 Vaccine Claim

August 11, 2020

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine, with no supporting clinical trial results.

Grand River Selected for Operation Warp Speed Efforts

August 11, 2020

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Allegations Put Kodak Pharmaceuticals Loan on Hold

August 10, 2020

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

FDA in Hot Seat on Buy American Drug Policy

August 10, 2020

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union

August 07, 2020

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine

August 07, 2020

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

EC Approves Roche’s Newest Anti-Cancer Drug

August 07, 2020

Roche has received approval from the European Commission for Rozlytrek (entrectinib), its newest anti-cancer drug, for two indications.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology

August 07, 2020

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.