News
FEATURED STORIES
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state.
In the wake of Pfizer’s voluntary market withdrawal of the popular sickle cell disease therapy, BioSpace looks at five investigational drugs currently making their way through the pipeline.
This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.
Pressure has been mounting for the Federal Trade Commission to take action, with Senator Elizabeth Warren last week urging FTC Chair Lina Khan to block the merger if it violates antitrust laws.
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
Merck’s investigational antibody clesrovimab demonstrated more than 60% effectiveness in reducing some types of respiratory syncytial virus-associated infections in infants, while Pfizer’s RSV vaccine Abrysvo showed 90% effectiveness at preventing the most severe RSV cases in adults 60 years and older.
Earlier this month, Kezar Life Sciences announced that the mid-stage test of zetomipzomib in lupus nephritis had been placed on an FDA clinical hold. Now, that program is being terminated.
As part of a strategic reorganization intended in part to support the ongoing launch of its postpartum depression drug, Sage Therapeutics is cutting more than 165 employees.
Real-world evidence show that GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis Apretude can prevent nearly all HIV infections, while rival Gilead Sciences is moving quickly toward an approval for a twice-yearly option.