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STAT+: FTC slams PBMs for boosting specialty drug prices at the expense of the U.S. health care system

STAT

billion in revenue by dispensing medicines to treat cancer, HIV, heart disease and other serious illnesses at prices that exceeded their estimated acquisition costs between 2017 and 2022. The FTC noted in its report that so-called specialty generic drugs represent a large and growing amount of spending by plan sponsors and patients.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

5 (May 10, 2024): e240921, [link] 6 Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Health Care Delivery System , Chapter 2, “Medicare Part B Drug Payment Policy Issues” (Washington, DC: MedPAC, June 2017), [link] www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default- source/reports/jun17_ch2.pdf.

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Driving change: Digital innovation and the future of drug discovery in India

Express Pharma

The collab- oration between industry and academia in drug development. link] collaboration-between-indus- try-and-academia-in-drug-de- velopment/ Singh, N., Frontiers in Drug Discovery, 3, Article 1201419. From target discovery to clinical drug development with human ge- netics. Bhérer, C., & Mooser, V.

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GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval. Each designation offers specific benefits to the drugmakers.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drug development. The ranks of trial site coordinators dropped even more steeply in these periods, dropping from approximately 56,036 to 40,472.

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FDA takes major step to ease access to CAR-T therapy

BioPharma Dive

According to the FDA, these REMS requirements are no longer necessary to ensure safe use of these CAR-T therapies as both physicians and hospitals are now well versed in managing the two syndromes most commonly associated with the drugs.