Remove 2019 Remove FDA Approval Remove Regulations
article thumbnail

Medicare program spent $1.8 billion in 2019 on drugs without confirmed clinical benefits

The Pharma Data

billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8

FDA 52
article thumbnail

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

article thumbnail

Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland

The Pharma Data

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Our median cycle time is industry leading at 16 days in the U.S.,

article thumbnail

How to advance AAV-based gene therapies

Drug Discovery World

What’s more, they are expensive, not readily available, and in many countries, there are a host of stringent regulations, as well as ethical and legal considerations around their use. Mouse models, on the other hand, are cost-effective and readily available, making them a favourite for many researchers. She received a Ph.D.

Therapies 162
article thumbnail

Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

FDA Law Blog: Biosimilars

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. Litigation filed by Vanda Pharmaceuticals against FDA (and the Federal Government) Since 2019 Case Number Title Nature of Suit Decision/Status 1:2019cv00301 (D.D.C.)

article thumbnail

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

The Pharma Data

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.