News

Roche Closes Agreement with Inflazome for $450 Million

September 21, 2020

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

Catalent and T-knife Enter into a Technology Transfer and Manufacturing Agreement

September 21, 2020

Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

September 21, 2020

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

Sanofi and GSK to Provide the EU with 300 Million Doses of its COVID-19 Vaccine Candidate

September 21, 2020

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

Lonza, Humanigen Partner to Expand Manufacturing of Lenzilumab for Potential COVID-19 Therapy

September 18, 2020

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

Novavax in COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India

September 18, 2020

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

Lilly and Amgen in Manufacturing Collaboration for COVID-19 Antibody Therapies

September 18, 2020

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

FDA Gives Guidance on Geriatric Information in Labeling

September 18, 2020

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy

September 18, 2020

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

EMA Recommends Seven Medicines for Approval

September 18, 2020

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.