Welcome to Trends-in-Medicine, offering independent, cutting-edge articles and information on drugs and devices in development. Our subscribers have access to news and analysis on the latest data, regulatory issues, and trends of interest to the healthcare community.

Neuroendocrine Tumor Update

As the treatment of neuroendocrine tumors evolves, scientists are developing targeted therapeutics to attack these cancers. At the NANETS virtual meeting, researchers reported positive data on a radiotherapeutic, called for more adjuvant treatment studies, uncertainty over the value of next-generation sequencing for NET, and some promising treatments.

Who Should Get the Covid-19 Vaccine First?

Now that a Covid-19 vaccine is close to a reality, the question is who should get vaccinated first. The answer depends on who you ask and whether you want to save the most lives or take the most “ethical” approach. The CDC’s Advisory Committee on Immunization Practices tackled this issue at their most recent meeting, and the conclusion was: prioritize healthcare workers over the elderly because it is more “equitable,” even though it doesn’t save nearly as many lives.

FDA Advisory Committee Rejects Alzheimer's Drug

An FDA advisory committee rejected Biogen and Eisai’s aducanumab to treat Alzheimer’s disease, disagreeing with the FDA on the data. The FDA tried to convince the panel that a failed trial, with a positive post hoc subgroup analysis, is sufficient for approval, but the panel was not buying that argument. The FDA is expected to make a decision by March 7, 2021. This is a very detailed synposis of the virtual meeting.

FDA Advisory Committee on Alzheimer's Disease Drug -- Preview

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting virtually on November 6, 2020, to discuss the biologics license application for Biogen and Eisai’s aducanumab, an intravenous treatment to delay clinical decline in patients with Alzheimer’s disease (AD). The FDA reviewers were surprisingly positive about aducanumab, but the FDA staff were not all on the same positive page. So, it should be an interesting meeting.

Dry AMD Therapeutic Development Summit

After some very disappointing trials in dry AMD and GA, retina specialists are hoping that one or more of the treatments currently in development – complement inhibitors or cell therapies – will be successful, but there are questions about regulatory issues, trial endpoints, lack of validated biomarkers, the meaningfulness of efficacy levels being achieved, efficacy in Asian patients, long-term compliance, insurance coverage, and more.

Neuroblastoma Treatment Update

Two new potential therapies for high-risk neuroblastoma were highlighted at the International Society of Paediatric Oncology (SIOP) virtual conference, and both look promising: Y-mAbs Therapeutics’ Danyelza (naxitamab), an anti-GD2, and a GD2/GD3 vaccine from Y-mAbs. There were also positive data on managing the side effects of the current anti-GD2, United Therapeutics’ Unituxin (dinutuximab).

FDA Advisory Committee Meeting on Covid-19 Vaccine Development

It isn’t just the general public that is concerned about the FDA granting an emergency use authorization to a Covid-19 vaccine. Members of an FDA advisory committee also expressed concern about lack of diversity (in terms of both race and age) in the trials, the 2-month follow-up, the bar for showing efficacy, and more.

Heart Failure: Implantable Sensors

Studies presented at HFSA suggested a number of ways that implantable pulmonary artery sensors can benefit heart failure patients, including detecting pulmonary embolisms, improving metabolic syndrome, reducing repeat hospitalizations, and patient satisfaction. All of the data was on Abbott’s CardioMEMS, but a Phase III trial is underway with Endotronix’s Cordella.