Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.

AstraZeneca has dosed the first participants in its Phase I clinical trial assessing the safety, tolerability, and pharmacokinetics of a combination of two monoclonal antibodies (mAbs) for the prevention and treatment of COVID-19.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

Müller + Müller will become part of DWK upon closing in September 2020 and will continue to function under the same name and management.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.

The Phase II trial is a randomized, placebo-controlled, observer-blinded study that will include patients aged 18 to 84 years.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

UK government has set up a new organization to replace Public Health England.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

Avacta Group has expanded its drug development partnership with LG Chem Life Sciences to include new programs incorporating Avacta’s Affimer XT technology.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

Bristol Myers Squibb will handle the development and commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing.

The collaboration will increase the supply of the potential treatment to at least three and a half times the current capacity.

The deal is expected to close during the second half of 2020.

A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

Plastic primary packaging could help prevent supply chain shortages associated with high demand for COVID-19 vaccines.

The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.

FDA published guidance regarding the development of treatments for acute myeloid leukemia.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.