News
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
After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
Both Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma have mid-stage data readouts this week, fueling the race in metabolic dysfunction-associated steatohepatitis.
Zealand Pharma said on Thursday that partner Boehringer Ingelheim will present the results from the study on Friday at the European Association of the Study of Liver Congress.
Structure Therapeutics is offering over nine million shares on the heels of mid-stage data for its oral GLP-1 receptor agonist, which showed weight loss of 6.2% in overweight or obese patients.
Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.
Novo Nordisk will face strong generic competition from at least 15 companies in China for its blockbuster GLP-1 receptor agonist products Wegovy and Ozempic, according to Reuters.
Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.