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Biotechnology Industry News
A closer look at phase 3 data on…
A closer look at phase 3 data on BioNTech and OncoC4’s anti-CTLA-4 antibody has shown the efficacy that excited analysts last week is offset by a challenging tolerability profile.
Ascletis Pharma has posted 7.7%…
Ascletis Pharma has posted 7.7% weight loss for the highest dose of its own entrant in the highly contested oral GLP-1 race.
Close to two years after AbbVie…
Close to two years after AbbVie handed over $48 million for the rights to Ose Immunotherapeutics’ inflammation drug, the Big Pharma now wants the French biotech to keep an eye on the asset for a
ORLANDO, Fla.—The leader of…
ORLANDO, Fla.—The leader of Gilead’s Kite Pharma is sure that anito-cel, the biotech’s next-generation multiple myeloma CAR-T challenger to Carvykti, is ready for prime time—and that the company is ready to bring CAR-T to the
ORLANDO, Fla.—With dosing…
ORLANDO, Fla.—With dosing underway in a pivotal phase 3 trial, Star Therapeutics is illuminating the clinical potential of its anti-bleeding antibody VGA039 with encouraging phase 1/2 results in a common bleeding disorder.
Novartis is divulging details from…
Novartis is divulging details from ianalumab’s phase 3 win in a rare autoimmune blood disorder, and the data suggest the treatment could delay the progression of patients to more serious forms of the disease
The industry’s mRNA alliance is…
The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the agency is eroding Americans' trust and threatening public health.
The FDA’s reported plan to move…
The FDA’s reported plan to move toward single-trial approvals has stirred industry concern, but one analyst views the proposal as a catalyst for greater R&D investment in the sector.
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.