Motto is the latest startup built at Redesign Health. The startup is virtual care platform that is now available for Californians and Texans with autoimmune and chronic inflammatory conditions. It seeks to increase access to care by offering virtual appointments with rheumatologists, condition management services and lifestyle coaching on its telehealth platform.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
The Japanese drugmaker had entered a neurology-focused partnership with Allergan in April 2016. AbbVie acquired Allergan last year, closing the deal in May.
Reuters reported that the drug, Rinvoq, will carry a list price of $59,000 per year. AbbVie's top-selling drug, Humira, is also approved for treating RA.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.
The drugmaker said Monday it would sell off the drug Otezla to address concerns about competition that the Federal Trade Commission had expressed in connection to the pending $74 billion deal. According to an analyst, BMS saw Otezla as competitive against its investigational TYK2 inhibitor.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
An expert pointed to the draft guidance's lack of distinction between immune-activating bispecifics and those that do not activate the immune system, as well as potentially burdensome trials industry may have to conduct. The comment period ended Tuesday.
Whether the FDA requires completion of a study to look at testicular toxicity before approval could dictate whether the drug launches next year or as late as 2022, an analyst wrote.
The company plans to file an IND in the second half of 2019. The company CEO says the "CAAR-T" therapies may avoid some of the potentially fatal toxicity risks of CAR-Ts for blood cancers.
The company has been busy forming development and commercialization partnerships with other firms to develop antibodies in oncology and rheumatology.
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.
On the last day of the ATA conference, three panelists explored the value in telemedicine and why it's key to apply the KISS (keep it simple, stupid) principle.
One of the many challenges of a rheumatoid arthritis diagnosis is the condition’s variability from patient to patient and over time. This unpredictability also impacts the effectiveness of drugs used to treat the disease. One company has developed a molecular test using a biomarker and an app to collect data to help physicians and patients […]
A firm that has developed joint fluid assays for orthopedic and rheumatology practices has raised just about all of its $5 million target to bring its tests to market. The first test, scheduled to launch in August, is to detect infection. Other tests being developed by CD Diagnostics will be rolled out next year, including […]
The experimental lupus treatment being developed by Argos Therapeutics is showing promise in early stage clinical trials, but the questions remain whether it’s enough progress to attract interest from a potential pharmaceutical partner. Argos released positive phase 1 clinical trial results for AGS-009 at the 2012 European League Against Rheumatism Congress (EULAR) in Berlin, […]
Pharmaceuticals distributor Cardinal Health (NYSE:CAH) has launched a web-based tool to help rheumatology practices better manage infusion therapy patients. Cardinal’s new InfusaTrack software is designed to make it easier for community rheumatology practices to offer in-office infusion therapy, which involves administering medication through a needle or catheter for patients whose conditions are too severe to […]
