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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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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.” The worst thing any marketer can do is over-promise and under-deliver.

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. What are the main advantages of EURneffy over similar treatments? Hand (N Y). 2007; 2(1):5-11. Derived from IQVIA Claims Data, 2023.

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Thursday pharma headlines

World of DTC Marketing

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 Annual U.S.

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Everything You Need to Know About Market Access in China

PM360

Medicines that are not listed in either Category 1 or 2, such as over the counter (OTC) and other prescription therapies (pembrolizumab, CAR-T therapy, etc.), FDA or EMA) and if the “Lecheng Medical Products Administration Bureau” recognizes the status of “clinical urgency.” References: 1. Ther Innov Regul Sci. 2023 Mar;57(2):343-351.

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