Johnson & Johnson Archives - Page 23 of 33

FDA approves Janssen’s Rybrevant for subset of non-small cell lung cancer

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy.

The agency also approved the Guardant360 CDx from Guardant Health as a companion diagnostic for Rybrevant.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence, in a statement. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

[Related: 25 promising pipeline drugs]<…

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 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 also overcame COVID-19-related clinical trial disruption and staffing hurdles, driving 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.

One of the most notable achievements involved the mRNA vaccines from Pfizer/BioNTech and Moderna, according to analyst Mani Foroohar at SVB Leerink.

Other achievements, according to Foroohar, includ…

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.

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.

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.

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.

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.

FDA approves J&J Vision’s overnight contact lens for myopia management

Johnson & Johnson Vision announced today that it received FDA approval for its Acuvue Abiliti overnight therapeutic lenses.

Jacksonville, Fla.-based J&J Vision touts the Acuvue Abiliti as the first and only FDA-approved orthokeratology (ortho-k) contact lens for managing myopia, according to a news release.

The company designed the Abiliti overnight ortho-k lenses to be fitted to match the eye based on its unique corneal shape and temporarily reshape the cornea. The technology uses corneal topography, refractive error and other measurements connected to the fitting software, which is user-friendly and provides a precise measurement of the corneal shape while accurately guiding the eye care professional through the fitting process.

Abiliti overnight lenses will be available in two forms — basic overnight therapeutic lenses and overnight therapeutic lenses for astigmatism, J&J Vision said. The company expects the lenses to be available in the U…

Phase 3 Tremfya results are promising for plaque psoriasis and psoriatic arthritis

Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one year.

A total of 55% of patients receiving Tremfya had complete skin clearance, while 85% had an Investigator’s Global Assessment (IGA) score of either 0 or 1 at week 252 in the Phase 3 trial. IGA is a five-point system for characterizing psoriasis severity. A score of zero indicates complete clearing, while a score of one is for “almost clear” skin.

With 2020 sales hitting $1.35 billion, Tremfya is the only interleukin (IL)-23 inhibitor that is FDA approved for both moderate-to-severe plaque psoriasis and psoriatic arthritis.

Janssen had concluded earlier that sev…

Canada approves J&J Vision’s drug-eluting contact lens

Johnson & Johnson Vision announced today that it received Health Canada approval for its Acuvue Theravision drug-eluting contact lens.

Jacksonville, Fla.-based J&J Vision’s Acuvue Theravision with Ketotifen is touted as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery. The company received Japanese approval for the lens last month.

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

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

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.

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.