Biofourmis Inc. scooped up $100 million in a series C round that was led by Softbank Vision Fund 2. The funds are earmarked to accelerate U.S. and global expansion of Biofourmis’ artificial intelligence (AI)-powered health analytics platform and to advance its pipeline of digital therapeutics. The company focuses software-based therapeutics and AI tools for personal predictive care and has U.S. FDA-cleared products that aim to boost clinicians’ ability to remotely monitor and treat patients.

Investigators have developed a new approach to classifying neurodegenerative disorders that used the overall patterns of protein aggregation, rather than specific proteins, to define six clusters of patients that crossed traditional diagnostic categories.

Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.

DUBLIN – Kurma Partners closed its third biotech fund, Kurma Biofund III, at €160 million (US$174 million), €10 million ahead of its initial target. The Paris-based fund will allocate the bulk of the capital to therapeutics firms, but it is also open to opportunistic investments in med tech, particularly in digital health applications and in biotech-med tech convergence, partner Peter Neubeck told BioWorld.

The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.

KARACHI, Pakistan – The government of Pakistan is tapping into mobile technology to protect its pharmaceutical supply chain and prevent abuse. As part of an ongoing effort to deal with an overabundance of fake and counterfeit medicines, Pakistan has introduced a mobile app that allows for instant access to the country’s National Essential Medicines List (NEML) while giving patients access to drug information and the ability to lodge complaints with regulators.

Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.

Before becoming the global head of Johnson & Johnson External Innovation, William Hait spent 30 years in academic medicine focused on oncology. Whenever he speaks to a group, the first question he asks is if there is anyone in the room that would like to get a disease.

Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.

Pharma has not gotten terribly serious yet about integrating digital health tools into clinical trials, let alone into their product offerings, despite the potential benefits they could offer when it comes to patient adherence, compliance and experience. Still, oncology giant Bristol Myers Squibb Co. has made a small step in that direction by partnering with Paris-based digital therapeutics company Voluntis SA.