Happy Friday, readers.
The Food and Drug Administration (FDA) wants the med tech industry to get inside patients’ brains.
The agency on Friday reported that it wants to encourage the development of brain computer interfaces (BCIs) as part of a “leap frog” guidance to help patients with disabilities regain control of their limbs.
“As part of these efforts, I’m announcing a significant step to promote the development of a new generation of implantable devices that can be more fully integrated with the patient’s own brain,” said FDA Commissioner Scott Gottlieb in a statement.
“Known as brain-computer interface (BCI) devices, they hold the potential for direct control of, for example, a limb prosthesis by the patient’s thought processes. This can allow significantly greater mobility and independence for patients. These devices have the potential to benefit people with severe disabilities by increasing their ability to interact with their environment.”
Regulators published the proposed (and non-binding) guidance on Friday as well, which includes proposals on the best ways to conduct clinical trials for these kinds of implantable devices.
Read on for the day’s news, and enjoy your weekend.
AbbVie strikes Voyager deal for Parkinson’s gene therapy. Biotech giant AbbVie, maker of the world’s best-selling drug Humira, has stuck a deal with the smaller Voyager Therapeutics to develop and market an experimental Parkinson’s disease gene therapy. The deal is worth $65 million in upfront cash, according to a press release, but could be worth billions more in downstream payments. It follows an existing collaboration between AbbVie and Voyager on neurodegenerative diseases; Voyager shares were up more than 20% in Friday trading.
$900,000 vs $4 million. Drug giant Novartis has been making the case that its experimental gene therapy for spinal muscular atrophy (SMA), a one-time treatment, would be “cost-effective” at a list price of somewhere between $4 million and $5 million. The Institute for Clinical and Economic Review (ICER) pegs things a bit differently – the pharmaceutical industry pricing watchdog (and gadfly) says that it would likely be worth somewhere between $310,000 to $900,000. Novartis hasn’t responded to the report; I have a sneaking suspicion they disagree with the analysis. (Reuters)
THE BIG PICTURE
Bombshells from the Sackler/OxyContin trial. ProPublica has published incendiary sealed testimony from a Sackler family member (part of the clan that owns Purdue Pharma, manufacturer of the opioid OxyContin) suggesting he embraced a proposed strategy to conceal the full details of the drug’s strength from doctors. A Sackler family representative said they stood by the testimony. (ProPublica)
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|Produced by Sy Mukherjee|