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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. The draft commission proposes to award medicines that meet “unmet medical needs” (UMN) an extra year of protection from generic competition.

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Commercial interests contribute to drug use and addiction

National Institute on Drug Abuse: Nora's Blog

Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. Such research can help guide policies as well as inform the development of evidence-based prevention and treatment interventions.

Drugs 105
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Transcending expectations for cell & gene therapy development

Drug Discovery World

Clinical trial sponsors need to coordinate the delivery of investigational medicinal products to clinical sites and the collection of samples from participants after they receive treatment. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5.

Therapies 130
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New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., vice president and head, global oncology development, AbbVie.

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Analysis Chemical Thank You PFAS regulation in California (late 2023 edition)

Agency IQ

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?