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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Healthcare Watch October 2023

PM360

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” “They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP).

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Three Ways Pharma Advertisers Can Benefit from Attention Metrics

Pharma Marketing Network

The FDA requires that pharmaceutical ads present the benefits and risks of a prescription drug in a balanced fashion, meaning a large portion of creative is dedicated to important safety information (ISI) rather than brand message. AU optimizations outperformed viewability across multiple Kantar brand lift categories.

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How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings.

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Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Medgadget

Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers. During this time, two additional studies ended successfully and were published, further validating the clinical safety and effectiveness.

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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. It potentially helps individuals lend some kind of concrete evidence to discussions with their healthcare provider.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. With restricted access and reduced prescription of puberty blockers and hormone therapies, the impact on pharmaceutical companies manufacturing these therapies also remains unclear.

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