Latest news with #drugapproval
Bloomberg
4 days ago
- Business
- Bloomberg
Expensive Cancer Drugs Don't Always Work
Hi, its Bob in soggy New Jersey. I'm about to head to the big annual cancer conference in Chicago. How many of those new drugs save lives? More on that in a moment, but first ... I've been reporting on the FDA's expedited drug approval process for a couple of years now. Critics say it's helped drug companies make billions on drugs that turned out to be ineffective. And the cost of cancer drugs came up again and again.
Bloomberg
19-05-2025
- Health
- Bloomberg
Eisai Shares Rise as New Alzheimer's Test Seen Helping Sales
Shares of Japanese drugmaker Eisai Co. gained after US regulators approved the first blood test to help diagnose Alzheimer's disease, fueling expectations of an uptick in demand for drugs used to treat the illness. Eisai's stock rose as much as 3.5% on Monday in Tokyo, the most in a month. The test, made by a unit of Japan's H.U. Group Holdings Inc., was cleared for people 55 and older who exhibit signs and symptoms of Alzheimer's, the US Food and Drug Administration said in a statement Friday. H.U. Group shares jumped as much as 8.6%, the most in a year.
Reuters
15-05-2025
- Business
- Reuters
Bayer US head says FDA chief reassured pharma executives of timely reviews
NEW YORK, May 15 (Reuters) - Bayer ( opens new tab Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry executives that the Food and Drug Administration would meet its targets for reviews despite recent job cuts and a restructuring. "We're looking at an FDA and scientific review staff that is stable, engaged and meeting its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said in an interview. Guth said that after a recent meeting between FDA Commissioner Marty Makary and industry executives, he was confident that the leadership wanted to maintain the agency's standards. Makary said last month the FDA will meet its targets for completing reviews of new drugs despite mass firings under the Trump administration. Reuters had reported in early April that firings at the FDA included employees critical to reviewing new medicines. "I heard an FDA commissioner who notes and acknowledged that the industry requires a stable and predictable regulatory environment," said Guth, adding that Makary underlined his intent to use technology to support FDA's work. The FDA is expected to decide whether to expand approval for Bayer's kidney disease drug Kerendia to patients with heart disease this year. Guth said Bayer's interactions with the FDA, predominantly its Center for Drug Evaluation and Research, had followed tight protocol and the agency had met its deadlines for experimental drugs under review. "We've seen the FDA responding within the timelines that are to be expected," he said. Bayer's experimental drug, elinzanetant, for treating menopause symptoms, is also under review. Guth said Bayer's first-quarter sales growth in the U.S., a key market, exceeded the 23% rise for North America reported earlier this week. Bayer does not break out sales by country. The U.S. accounted for a "significant chunk" of its sales of new prostate cancer drug Nubeqa and kidney treatment Kerendia, he said. On Tuesday, the company reported a combined 680 million euros ($760.51 million) in revenues from both drugs. ($1 = 0.8941 euros)
Bloomberg
13-05-2025
- Health
- Bloomberg
FDA Appointee Is a Notorious Drug Critic With a Lot to Prove
The controversial appointment of oncologist Vinay Prasad — an outspoken critic of the pharmaceutical industry and US health agencies — to a key role within the Food and Drug Administration was a shock for drug companies. Biotech stocks immediately fell over fears that the bar for drug approvals suddenly got a lot higher. Tightening regulatory standards is a reasonable goal. But achieving it requires delicately balancing evidence and compassion, weighing certainty against speed. Prasad has had a lot to say over the years about how companies and the FDA have gotten that balance wrong. Now, as the director of the Center for Biologics Evaluation and Research, which oversees vaccines, gene therapies and the blood supply, he has to prove that he can get it right.
CNA
08-05-2025
- Business
- CNA
US FDA centers to deploy AI internally, following experimental run
The U.S. Food and Drug Administration said on Thursday all its centers will deploy artificial intelligence internally immediately, with full integration on June 30, following the completion of a new generative AI pilot for scientific reviewers. WHY IT'S IMPORTANT Once the FDA receives an application for the potential approval of a drug, it has six to 10 months to make a decision. The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process, the regulator said. KEY QUOTE "Future enhancements will focus on improving usability, expanding document integration and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy," the regulator said. CONTEXT On Wednesday, Wired reported the drug regulator was in talks with OpenAI to discuss the use of AI, citing sources with knowledge of the meetings. The report added a small team from OpenAI had met with the FDA and two associates of Elon Musk's so-called Department of Government Efficiency multiple times in recent weeks. WHAT'S NEXT The agency will continue to assess performance, gather user feedback and refine features to support the evolving needs of its staff. Additional details and updates on the AI use will be shared publicly in June.
