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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.
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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.
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Danish biotech Bavarian Nordic announced Wednesday it is discontinuing its immuno-oncology program and will focus its R&D efforts on infectious diseases.
If you’re a sales professional looking for a new position, here are some companies currently looking to fill sales roles on BioSpace.
Artificial intelligence and a flood of data in the pharmaceutical industry will likely change some of the current functions of its data scientists, experts say, but the ability to learn and adapt to new technologies will remain key in this role.
President and COO Robert Michael will take over Richard Gonzalez’s CEO duties, AbbVie announced Tuesday. Gonzalez will become executive chairman of the board of directors.
The litigation alleges the regulator allowed its competitor Liquidia to skirt FDA precedents by amending an already pending NDA to add a PH-ILD indication instead of filing a new application.
After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
ViiV Healthcare and GSK’s Cabenuva in a Phase III study showed superior efficacy versus daily oral antiretroviral treatment in HIV patients with a history of difficulties in taking daily pills.
With over 20% of people born between 1997 and 2003 identifying as a sexual and gender minority, moderated panels at SCOPE 2024 discuss the need to engage this community in clinical trials.
FDA
Johnson & Johnson’s anti-BCMA antibody can now be dosed once every two weeks in relapsed or refractory multiple myeloma patients who have achieved and maintained complete response for at least six months.
A federal judge in New Jersey has agreed to hear legal challenges from BMS, J&J, Novartis and Novo Nordisk to the Inflation Reduction Act’s Drug Price Negotiation Program during the same March 7 hearing.