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Bulletin: Transcatheter Cardiovascular Therapeutics (TCT)

There will be 16 late-breaker trials presented at the TCT meeting, sponsored by the Cardiovascular Research Foundation (CRF), in Denver from October 29 – November 2, 2017, along with 12 first report investigations.

Bulletin: Treatment Of Uterine Fibroids

The Society of Interventional Radiology (SIR) denies it is in a turf war with OB-GYNs over the treatment of uterine fibroids (leiomyoma), but there is tension. SIR is upset because they believe OB-GYNs are not informing women with uterine fibroids about a treatment option they can get from interventional radiologists. SIR president Suresh Vedantham, MD, from Washington University School of Medicine, said uterine fibroid embolization (UFE) – a procedure interventional radiologists provide – is “vastly underutilized.”

FDA Advisory Committee Recomends Approval Of Dynavax's Helplisav-b Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 12-1 (with 3 abstentions) that Dynavax Technologies’ Heplisav-B, a hepatitis B vaccine, is safe. The proposed indication is for immunization against infection caused by all known subtypes of hepatitis B virus in adults age ≥18. It would be administered in two 0.5 mL doses, given four weeks apart.

Bulletin: FDA Approves First Gene Therapy

The FDA approved Novartis’ Kymriah (tisagenlecleucel, CTL-019), a CD19 CAR T cell therapy – the first gene therapy approved in the U.S. – for B-cell precursor acute lymphoblastic leukemia (ALL) patients age ≤25 with disease that is refractory or in second/later relapse.

FDA Advisory Committee Unanimously Recommends Approval Of Gene Therapy For All

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met to review the biologics license application for Novartis’ tisagenlecleucel-T (CTL-019), an intravenous CAR T therapy for treating pediatric and young adult patients (age 3-25) with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). The panel voted unanimously (10-0) that the benefits outweigh the risks, sending a strong message to the FDA in favor of approval. The FDA PDUFA date is October 3, 2017.

FDA Public Meeting On Abuse-Deterrent Opioids

The FDA held a 2-day public workshop to discuss abuse-deterrent opioids and their impact on misuse, abuse, addiction, overdose, and death. The meeting, which focused on data and methods needed to evaluate abuse-deterrent formulations (ADFs) in the postmarket setting, came on the heels of the FDA’s decision that Endo’s Opana XR (oxycodone extended-release) should be withdrawn from the market and Endo’s agreement to do that.

Bulletin: CDC Report On Opioid Prescribing Trends

The Centers for Disease Control and Prevention reported on county-level trends in opioid prescribing from 2010-2015, showing prescription opioids continue to be a serious problem, with wide variations from county-to-county.