Drugs

Publicly Supported Drug Research Plays Valuable Role: Study

Harvard Medical School researchers say that publicly supported research was central to the development of at least 25% of all new drugs approved by FDA between 2008 and 2017. Writing in the BMJ, the researchers say that the public support came either through direct contributions to drug development or through formation of spin-off companies based on earlier public funding.

“Drugs approved following major public sector funding were more likely to receive an expedited development or approval pathway designation from FDA and more likely to be a first-in-class treatment,” the researchers write, “suggesting that they were more likely to be novel and potentially clinically important.”

The study also documented a substantial increase in the share of drugs in the U.S. with publicly supported research origins compared with previous studies.

The article says the results have implications for healthcare and regulatory policy, particularly in the U.S. The authors say that identification of drugs with late stage, publicly supported research contributions, particularly those for which such institutions hold key patents, could represent a useful policy lever in negotiating lower prices to consumers. They cite three drugs that relied on substantial academic development — Biogen’s Spinraza (nusinersen), Sanofi Genzyme’s Cerdelga (eliglustat), and Astella and Pfizer’s Xtandi (enzalutamide) — and are priced in the U.S. at $129,000 to $750,000 per year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome