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Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
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
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.
In an SEC filing on Friday, Alumis said it aims to start late-stage trials of a TYK2 inhibitor in plaque psoriasis this year and is seeking public funding for the studies.
Skye Bioscience is putting the kibosh on its SBI-100 candidate for glaucoma, and the company’s entire ophthalmology program, after a mid-stage study did not reach its primary endpoint.
Moderna’s combination vaccine candidate for COVID-19 and influenza outperformed licensed vaccines in older adults, according to late-stage results reported on Monday.
Lilly’s tirzepatide achieved an absence of metabolic dysfunction-associated steatohepatitis without the worsening of fibrosis in more than 50% of patients in a mid-stage study, the company reported Saturday.
While a prolonged, 15-day regimen of Paxlovid is safe, it appears to be ineffective at lowering the symptoms of long COVID, according to results of a Phase II trial funded by Pfizer and conducted by Stanford Medicine.
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
Biomea Fusion’s early-stage investigational diabetes treatment BMF-291 has been slapped with a full FDA clinical hold on its Phase I/II trials due to concerns over liver toxicity.
Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.
The companies announced Friday that their candidate survodutide, which is licensed to Boehringer Ingelheim from Zealand Pharma, improved fibrosis in more than 50% of treated patients with metabolic dysfunction-associated steatohepatitis.