fiercepharma.com
With more and more expensive gene therapies hitting the market, one-dose, curative treatments are continuously shuffling the list of the U.S.’ highest-priced drugs. In just two years, half of Fierce Pharma’s 2023 list of the most expensive drugs has been replaced with a fresh crop of newer, pricier treatments. Each of the drugs on this year’s list are one-dose therapies, prompting goodbyes to pharmacy-dispensed drugs like Myalept, a leptin deficiency med that for years was one of the world’s most expensive with its $1.26 million yearly cost. | Multimillion-dollar one-dose therapies from Kyowa Kirin, CSL and Sarepta are just some of 2025's most expensive drugs in the U.S.
4 months ago
fiercepharma.com
After beating quarterly earnings expectations and raising its full-year sales outlook from a previously forecast decline, Biogen’s “new Biogen” is beginning to take shape. | The company's 7% quarterly sales growth prompted an updated full-year sales outlook to flat, up from a previously expected slight decline.
5 months ago
fiercepharma.com
With its latest $50 billion U.S. manufacturing investment and record U.S. growth, is British AstraZeneca looking at itself as an American company? | AstraZeneca CEO Pascal Soriot said the company has had many talks with the U.S. government and has proposed price reduction plans for its drugs.
5 months ago
fiercepharma.com
Novartis and its Fabhalta may have been first to the punch in ultrarare kidney disease complement 3 glomerulopathy (C3G), but Apellis Pharmaceuticals has delivered a checkmate with a wider label an | Apellis's Empaveli is the first drug to reach the IC-MPGN market and will compete against Novartis' Fabhalta with a broader label in C3G, another rare kidney disease.
5 months ago
fiercepharma.com
With high drug prices remaining an ongoing concern for U.S. | A direct-to-consumer program for its drugs could bring down higher U.S. drug prices while cutting out pharmacy benefit managers.
5 months ago
fiercepharma.com
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ambitions with a glimmer of hope. | The FDA was set to decide on GSK's proposed Blenrep combinations in multiple myeloma by July 23. Instead, the agency is now extending its review through October 23.
5 months ago
fiercepharma.com
FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.
5 months ago
fiercepharma.com
Moderna, already in cash-saving mode amid uncertain vaccine dynamics, is backing off from its plans to construct an mRNA drug substance plant in Japan. | The company attributed its decision to cancel its plans for an mRNA manufacturing plant in the country to "changes in the business environment both globally and in Japan."
5 months ago
fiercepharma.com
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with ocular toxicity side effects, proposed dosing and a lack of diversity in GSK's trial program.
5 months ago
fiercepharma.com
As advances in artificial intelligence technology continue to offer enticing benefits to industries across the board, pharma leaders aren't looking to miss out on implementing the technology into t | Define Ventures' report on the industry's approach to AI found that 85% of Big Pharma leaders consider AI an "immediate priority," with 85% planning to increase their AI budgets in turn.
5 months ago
fiercepharma.com
The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures. | The FDA listed observations at plants run by Sun Pharma, Daewoo Pharmaceutical and Glenmark, citing concerns ranging from mold to quality control issues.
5 months ago
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