How PhysIQ is advancing digital therapeutics through its partnership with Janssen

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform. 

Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount.

Virtual care became the norm after the COVID-19 pandemic hit, and, although a return to something resembling “normal” could be on the horizon, those at artificial intelligence–based technology developer PhysIQ see that the landscape has been reshaped since early 2020.

“Digital medicine has been evolving but a lot of what’s been done has been done in an exploratory capacity,” PhysIQ CCO Chris Economos told MassDevice. “COVID-19 has definitely changed that.”

Get the full story at our sister site, MassDevice.

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Pharma 50: Here’s how the world’s largest pharma companies are doing

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead.

That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest pharma companies in the world. (Browse data on all 50 companies here.)

Overall, the 50 largest pharma companies brought in $851 billion in sales in 2020. Pharma companies last year overcame clinical trial disruption and staffing hurdles to drive unprecedented R&D advances to introduce novel vaccines and therapies to battle the pandemic. The resulting shift in public perception could benefit the industry for years to come.

Get the full story on our sister site Drug Discovery & Development. 

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FDA, CDC lift pause on J&J COVID-19 vaccine

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Get the full story at our sister site, Pharmaceutical Processing World.

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Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots.

At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that a warning for this potential issue should be added to the vaccine’s product information and the events should be listed as a very rare side effect of the vaccine, according to a news release.

The committee considered all available evidence of the events, which came to the fore after six reports of blood clots and one death in the U.S., which led to the country pausing use of J&J’s vaccine. EMA cited eight reports from the U.S. regarding blood clots among more than 7 million people who had received the J&J vaccine.

Blood clots occurred mostly at unusu…

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FDA approves oral multiple sclerosis treatment from J&J’s Janssen unit

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment.

Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

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Johnson & Johnson applies for vaccine approval from FDA

Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate.

New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints, according to a news release.

The company expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.

READ: Which companies will likely produce the most COVID-19 vaccine i…
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Verana Health to collaborate with Janssen on ophthalmology and urology research

Verana Health (San Francisco), which has expertise in turning clinical data into real-world evidence, announced today that it has inked a research collaboration agreement with Johnson & Johnson‘s Janssen Research & Development.

The research with Janssen will have an ophthalmology and urology focus.

In the ophthalmology space, Verana Health will analyze the American Academy of Ophthalmology’s IRIS registry data to characterize baseline patient attributes, disease progression, and treatment-based outcomes for people treated for diabetic macular edema, a complication of diabetes that impacts 750,000 Americans and may lead to severe vision loss.

The urology research will focus on early-stage prostate cancer. The first phase of the pilot will involve curating and evaluating de-identified data from a small subset of patients in the American Urological Association Quality (AQUA) registry.

“Characterizing early-stage prostate cancer ha…

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Johnson & Johnson vaccine trial results expected soon

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon.

The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.

Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”

J&J published interim phase 1/2a data from its vaccine trial in the New England Journal of Medicine last week, with the data demonstrating that the single-dose vaccine candidate provided an immune response that l…

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