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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug. appeared first on Drug Discovery World (DDW).

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Commercial interests contribute to drug use and addiction

National Institute on Drug Abuse: Nora's Blog

3 The CDC estimates that more than 178,000 people die in the United States each year from diseases attributable to excessive alcohol use, 4 and more than 480,000 people die annually from causes attributable to tobacco use. link] Centers for Disease Control and Prevention. 6 Considering that an estimated 3.27 Smoking and Tobacco Use.

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Transcending expectations for cell & gene therapy development

Drug Discovery World

As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. There are over 7,000 genetic diseases that could potentially be cured using gene therapy 10. " Critical Considerations For Packaging And Delivery Of Gene Therapy Products."

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Analysis Chemical Thank You FDA updates list of chemicals in the food supply under agency review

Agency IQ

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

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Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

The Pharma Data

1 Clinical remission was defined by Crohn’s Disease Activity Index (CDAI) in the U.S. “These results represent another step towards the development of risankizumab for these patients, many of whom do not find sufficient disease control with current treatments.” NORTH CHICAGO, Ill. vice chairman and president, AbbVie.

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Deliberate Dysentery

Codon

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. How are disease targets selected for challenge trials?

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Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Agency IQ

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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