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EMA launches tools to accelerate development of medicines
The European Medicines Agency (EMA) has launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need.
After the completion of a two-year pilot, the EMA has integrated these additional tools to support continued scientific dialogue, aiming to give developers faster answers and better support preparation for the submission of a marketing authorisation application.
The first tool, the regulatory roadmap and product development tracker, helps chart a medicine’s progress and flag potential issues early, making it easier for developers and the EMA to stay aligned throughout development.
The second tool, the expedited scientific advice, is a fast‑track route for developers to receive timely and focused regulatory input on focused questions that are critical for the development process.
The third tool, the submission readiness meeting, is a dedicated check-in, about a year before submission, where the EMA and developers discuss the progress of the programme against the plan and identify any remaining evidence gaps to ensure that a comprehensive data package is available for a thorough evaluation by the Committee for Medicines for Human Use (CHMP).
Head of Scientific Evidence Generation at the EMA, Michael Berntgen, commented: “Over the 10 years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of innovative medicines. The new features we are now rolling out following the pilot enhance our ability to identify and address critical issues early in the development process through continuous scientific dialogue with the developer.”
The EMA says the results of the pilot indicate that the new PRIME features promote enhanced regulatory agility and better support to developers. They also come at a crucial time as the EMA prepares for operation under the revised EU pharmaceutical legislation.
The post EMA launches tools to accelerate development of medicines appeared first on Drug Discovery World (DDW).
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcells and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
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STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
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FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes. Read More
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