The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
An AI-driven app called juli improved symptoms of asthma and depression, two randomized controlled trials found. The app takes in data from electronic medical records, smartphones, wearable devices, the environment and patient questionnaires to provide personalized health recommendations.
The FDA approved Airsupra, an asthma rescue inhaler that administers two different medications, one that opens up airways and another that treats inflammation. The inhaler stems from a partnership between AstraZeneca and Avillion.
Third Harmonic Bio’s IPO raised $183.3 million for clinical development of an inflammation drug licensed from Novartis. The biotech was able to find enough investor interest to increase the deal size, offering 1.9 million more shares than initially planned.
Third Harmonic Bio, which emerged from stealth early this year with a lead drug from Novartis and a $105 million round of funding, has not yet set any financial terms for its planned IPO. But the biotech plans to use the IPO cash for early and mid-stage clinical tests of its small molecule in multiple inflammatory indications.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
New company Areteia Therapeutics launched with up to $350 million in financing and an asthma drug candidate from Knopp Biosciences. That drug, dexpramipexole, previously failed a pivotal test in amyotrophic lateral sclerosis but more recent clinical testing found that the way the small molecule works has applications in eosinophilic asthma, a severe form of the respiratory disease.
The drugmaker struck a collaboration agreement with Mass General to use its platform for heart failure and asthma management. The health system plans to launch two pilots of the digital health platform.
The University of California Irvine will conduct the virtual study, that was designed with Apple. It will look at how devices such as an Apple Watch or iPhone could be used to help patients with asthma self-manage their condition.
Known as CapMedic, the device signals patients to help them use inhalers correctly. Developers hope the feedback mechanism distinguishes the device from other smart inhalers.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
David Van Sickle's eyes shine as he outlines the array of opportunities that have opened up ever since medical device maker ResMed acquired the Wisconsin startup in January 2019 for $225 million.
While well-developed in cancers, precision medicine's readiness for prime time beyond oncology varies markedly from disease to disease. But reimbursement remains a significant hurdle.
In a phone interview, Propeller Health CEO David Van Sickle and CTO Greg Tracy discussed how their digital therapeutics company has evolved since its founding in 2010.
In an earnings call last week CVS Health CEO Larry Merlo outlined some of the ways that the company is moving forward on plans to reduce medical costs after its $69 billion purchase of Aetna.
The goal is to expand its connected device capabilities beyond asthma and COPD inhalers to include other diseases and drug delivery devices.