News

FDA Grants Emergency Use Authorization to Eli Lilly COVID-19 Antibody Cocktail

February 11, 2021

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

EMA Clarifies Position on Sputnik V European Approval Process

February 11, 2021

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

Evonik Invests in Additional Lipid Production for mRNA-based Vaccines

February 11, 2021

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

Europital’s Scientific Advisory Board Predicts Clinical Deficit May Slow Biotech Advancement

February 11, 2021

The recently formed scientific advisory board of Europital anticipates that a deficit in the clinical knowledge of smaller biotechs may lead to slow development in 2021.

FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Lymphoma Treatment

February 10, 2021

The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.

AstraZeneca and IDT Biologika Plan Vaccine Capacity Expansion

February 10, 2021

The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.

New Leadership for FDA Entangled in Politics

February 10, 2021

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.

Florida Manufacturer Warned for Inadequate Written Procedures

February 10, 2021

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants

February 10, 2021

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

AbbVie to Collaborate with Caribou Biosciences on CAR-T Cell Therapeutics

February 10, 2021

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.