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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.
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Read our takes on the biggest stories happening in the industry.
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
Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
The company’s treatment for IgA nephropathy, sparsentan, failed to meet statistical significance by a measure of kidney function in a head-to-head confirmatory study versus irbesartan.
After announcing a $1 billion radiopharma deal with PeptiDream, Genentech signed a separate deal with Orionis Biosciences for its molecular glue degraders to target cancer and neurodegeneration.
Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.