Posted inGenetics
Industrializing Small-Batch RNA-Based Therapeutics
With the question of immunotherapeutics’ efficacy answered in the resounding affirmative, the challenge has shifted to the practical considerations of…
Posted inMedical Technology
GE HealthCare, Mayo Clinic launch digital twin project for personalizing radiation cancer therapy
GE HealthCare and the Mayo Clinic are expanding their long-running collaborative work to now include the development of new personalized…
Posted inGenetics
Primary Packaging Materials for Parenteral Products
Figure 1: Examples of Primary Packaging Material Options for Parenteral Drug Products. Primary packaging material (PPM) refers to the material…
Posted inBiotechnology
FDA slaps hold on Denali’s plans for phase 1 rare disease trial
The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns…
Posted inMedical Technology
After more than 20 years, Medtronic claims deep brain stimulation approval for dystonia
In 2003, Medtronic first received a humanitarian green light from the FDA to offer its deep brain stimulation implants to…
Posted inBiotechnology
Is biopharma facing a microbial manufacturing crunch?
Chris Hayden:Hi everyone. Thank you for joining us today. My name is Chris Hayden. I'm a producer here at FIERCE.…
Posted inBiotechnology
Crescent waxes pipeline with $80M Kelun deal, bagging ADC to pair with PD-1xVEGF bispecific
Crescent Biopharma has agreed to pay Kelun-Biotech $80 million for ex-China rights to an antibody-drug conjugate, positioning the biotech to test…
Posted inBiotechnology
Royalty pens $275M financing deal for Denali drug awaiting delayed FDA decision
While Denali Therapeutics awaits a delayed FDA decision on its Hunter syndrome drug, the biotech is already banking on the…
Posted inBiotechnology
AstraZeneca’s latest amyloidosis pact with Neurimmune could reach $780M
Almost four years after penning its first amyloidosis collaboration with Neurimmune, AstraZeneca has returned to pick up a second asset.…
Posted inBiotechnology
FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER),…