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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The analysis focused on Medicare Part B and Part D spending — which covers outpatient medical care and prescription drugs, respectively, — in 2017, 2018 and 2019, the researchers said. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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“Game-changing” obesity drug over-promising?

World of DTC Marketing

Novo Nordisk has admitted that it would not be able to keep up, adding that it would likely take until early 2022 for the supply to stabilize and that some patients “are experiencing an approximate one month or longer delay in filling prescriptions for Wegovy.”

Insurance 271
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Sorry, the Inflation Bill won’t lower healthcare costs

World of DTC Marketing

It’s no wonder that voters consistently rank bringing down prescription drug prices and other measures to reduce the cost of care as among Congress’ top priorities. Congress rightly chose to negioate drug prices for Medicare, but prescription drugs are only 10-12% of every healthcare dollar we spend. As the U.S.

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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011. The reason for this review extension was undisclosed in the announcement.

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

However, reports and surveys say that only half of people with an epinephrine needle-injector prescription consistently carry their device, 4 and for patients and caregivers who do carry a needle-injector, more than half either delay or do not administer it in an emergency. Hand (N Y). 2007; 2(1):5-11. Derived from IQVIA Claims Data, 2023.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Herbal medicines placed on the market since April 2011 must have either a traditional herbal registration (THR) or a Marketing Authorisation (MA). 2012/1916). 2012/1916).

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Voice is Becoming the Loudest Tool in the Exam Room

PM360

The line from the 2011 Pixar “Cars” sequel (trust me, as a parent of two, I have seen it countless times) points to the practical implication for voice technology. Health systems are signing off on network-wide solutions that use AI companions to record conversations, compile EHR notes, and even order tests and prescriptions.