MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence. Photo: Bulat Silvia, Getty Images

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

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Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. biologics market and reduce prescription drug costs. biologics market and reduce prescription drug costs.

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Clarivate

MARCH 17, 2022

Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Ahead of the meeting, the FDA highlighted nonclinical findings (i.e., We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Clarivate

OCTOBER 30, 2022

The FDA allowed DTx products for psychiatric disorders to be marketed as class II medical devices without FDA clearance during the public health emergency declared for the COVID-19 pandemic, which was recently extended to run through the remainder of 2022. As a result, few products have FDA clearance. What’s next?

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PM360

SEPTEMBER 15, 2022

People get tired of feeling that they are their sickness; they’re tired of carrying the baggage of being a “patient,” and they want to be seen and treated like the person they are, not the prescription they take. In order to improve patient inclusivity in clinical trials, the biopharma industry must incorporate DEI in all processes.

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Clarivate

NOVEMBER 23, 2021

For example, in the United States, the FDA’s view on data is evolving, especially as it concerns upstream usage for clinical and regulatory use cases. Our current classic use cases are very much immediately pre-launch, post-launch, a lot of commercial analytics, brand and marketing teams, but amidst a few major changes in the backdrop.

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PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Their authenticity and credibility is their superpower—don’t diminish that by being overly prescriptive. Regardless of the tactics and strategies employed, I would encourage more biopharma professionals to get personally involved in patient engagement programs.

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Clarivate

AUGUST 20, 2024

Moreover, the initial set of negotiated prices represents the first step of a process that eventually will reshape the pricing and reimbursement landscape for prescription drugs under Medicare as CMS gradually replaces private payers as the chief negotiating partner for some of the drug industry’s largest-selling treatments.

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Clarivate

OCTOBER 17, 2024

Since the government first created a Part D benefit with the Medicare Modernization Act of 2003 (MMA) , Democrats have agitated for greater governmental input into the cost of prescription drugs for Medicare beneficiaries. Such a change would sharply increase the number of people covered under this program.

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