Industry News
Biotechnology Industry News
Encoded Therapeutics has linked…
Encoded Therapeutics has linked its Dravet syndrome gene therapy ETX101 to a 78% reduction in seizures, keeping the biotech on track to start a pivotal study next year.
Having already claimed a win for…
Having already claimed a win for the phase 2 study of its seizure drug, Praxis Precision Medicines is hoping fresh efficacy data will form the backbone of an approval application for its sodium channel inhibitor.
Pfizer’s VC arm has backed a…
Pfizer’s VC arm has backed a $100 million series A raise for OTR Therapeutics as the Chinese biotech tacks on preclinical neurological assets to its varied portfolio.
The top spot at the FDA’s Center…
The top spot at the FDA’s Center for Drug Evaluation and Research (CDER) has been a revolving door during President Donald Trump’s second term, and it took its latest shocking turn earlier this week: FDA
Pharma and biotech companies have…
Pharma and biotech companies have access to an unprecedented wealth of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data.
The FDA has placed a hold on…
The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies.
AGC Biologics’ Dieter Kramer…
AGC Biologics’ Dieter Kramer shares insights, data and possible solutions as demand for late-phase microbial capacity accelerates
Crescent Biopharma has agreed to…
Crescent Biopharma has agreed to pay Kelun-Biotech $80 million for ex-China rights to an antibody-drug conjugate, positioning the biotech to test the asset in combination with its PD-1xVEGF bispecific.
While Denali Therapeutics awaits a…
While Denali Therapeutics awaits a delayed FDA decision for its Hunter syndrome drug, the biotech is already banking on the therapy’s commercial success.
Almost four years after penning…
Almost four years after penning its first amyloidosis collaboration with Neurimmune, AstraZeneca has returned to pick up a second asset.
The FDA has named Tracy Beth…
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing the rapid rise of a physician who rose to prominence during the pandemic.
The FDA has proposed cutting fees…
The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad.
Capricor Therapeutics has notched…
Capricor Therapeutics has notched a key win in its efforts to bring Duchenne muscular dystrophy cell therapy deramiocel to market, hitting the primary endpoint in a phase 3 trial.
Triana Biomedicines has tapped…
Triana Biomedicines has tapped Pfizer Ventures and a number of other existing and new investors to secure a $120 million series B the biotech will use to take its lead molecular glue degrader into the
A phase 3 trial of Pharvaris’…
A phase 3 trial of Pharvaris’ deucrictibant has hit its primary endpoint, positioning the biotech to file for approval of a challenger to KalVista Pharmaceuticals’ Ekterly in a rare genetic disease.
Laboratoires Théa has penned a…
Laboratoires Théa has penned a deal potentially worth up to $280 million to get its hands on Iolyx Therapeutics’ phase 3-ready eye disease drug.
Muvon Therapeutics has linked its…
Muvon Therapeutics has linked its cell therapy to a 60% drop in stress incontinence episode frequency in a small phase 2 trial, leading the biotech to pitch the candidate as a way to reduce reliance
Weeks after being named the…
Weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., has taken steps to retire as head of the FDA’s Center for Drug Evaluation and Research at the end of this month.
How Cerevance’s innovative,…
How Cerevance’s innovative, non-dopaminergic approach is paving the way for breakthroughs in Parkinson’s, offering patients improved quality of life
The FDA has released a plan to…
The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies, the latest expansion of the regulator’s efforts to eliminate animal testing in drug