News

The Denton site is part of a network of manufacturing plants Novartis is building across the U.S. to make cancer drugs that must be shipped to patients quickly.
FEATURED STORIES
IPO
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
Job Trends
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.
FDA
Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
Drugmakers, including the genetic testing company 23andMe, are using novel approaches to stimulate NK cells’ intrinsic ability to recognize and kill tumor cells.
In this deep dive, BioSpace takes a closer look at the drug price crisis in the U.S. As President Joe Biden and former President Donald Trump gear up for a rematch in the 2024 election, we explore how federal reforms to lower costs could be leveraged on the campaign trail.
The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly.
The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.