How the FDA approval of J&J’s Opsynvi could simplify treatment and improve outcomes for PAH patients

[J&J]

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson.

“With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J spokesperson, highlighting the therapy’s alignment with current clinical guidelines recommending early use of combination therapy. The three treatment pathways include the endothelin, prostacyclin and nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathways. 

The impact of Opsynvi PAH combination therapy

Before the approval, the DUE study for the combination therapy was featured in The Journal of the American College of Cardiology. The tria…

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How the FDA approval of J&J’s Opsynvi could simplify treatment and improve outcomes for PAH patients

[J&J]

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson.

“With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J spokesperson, highlighting the therapy’s alignment with current clinical guidelines recommending early use of combination therapy. The three treatment pathways include the endothelin, prostacyclin and nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathways. 

The impact of Opsynvi PAH combination therapy

Before the approval, the DUE study for the combination therapy was featured in The Journal of the American College of Cardiology. The tria…

Read more
  • 0

Are Big Pharma giants getting the right ROI on their R&D investments? A visual exploration

[Image courtesy of Adobe Stock]

While annual reports show broadly similar R&D strategies among Merck & Co., Pfizer, Johnson & Johnson and AbbVie, their 2020–2023 financial metrics reveal a concerning trend. Merck & Co. may be the new top dog of Big Pharma, but the firm’s 1.4% revenue growth in 2023 represents a significant slowdown. Pfizer’s 41.7% revenue decline from its COVID-inflated $100.3 billion peak in 2022 is even more stark. Similarly, J&J’s modest 4.2% growth and AbbVie’s 6.4% revenue dip also signal a departure from previous patterns.

In raw numbers, R&D spending in the pharmaceutical industry has surged over the past few decades, jumping from about $30 billion across the industry to more than $200 billion annually by the 2020s. Despite record-breaking R&D spending hitting $161 billion in 2023, marking a nearly 50% increase since 2018, as IQVIA has noted, …

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Cerenovus President Mark Dickinson on the future of stroke care

Cerenovus President Mark Dickinson forecasts the innovative technologies that will advance stroke care in the coming years.

Cerenovus Worldwide President Mark Dickinson [Photo courtesy of Johnson & Johnson MedTech]

It’s getting harder to beat aspiration systems for fast and simple thrombectomies to remove blood clots that are blocking oxygen from a stroke patient’s brain.

That’s according to Cerenovus Worldwide President Mark Dickinson, who discussed the future of stroke care in an interview with Medical Design & Outsourcing.

“It’s a very simple concept that the larger the tube you can get to face the blood clot, the more likely you’re going to be able to evacuate that clot just through suction,” he said. “And advances in technology have enabled us — and, candidly, others in the marketplace — to be able to design these larger bore, larger sized devi…

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Johnson & Johnson launches research partnerships network

Johnson & Johnson (NYSE:JNJ) announced today that it has launched the J&J Centers for Global Health Discovery, a global network of research partnerships to address the world’s health challenges.

The first J&J Satellite Center for Global Health Discovery is at the London School of Hygiene & Tropical Medicine. The pharma and medtech giant plans to open additional J&J Centers through 2022.

Each Satellite Center will focus on entrenched and emerging health threats that are pressing and have a high unmet need. Think tuberculosis (TB), dengue fever, flavivirus, coronavirus and antimicrobial resistance (AMR).

“COVID-19 has shown us that investments in early-stage research, such as novel vaccine technologies, are critical to accelerate our fight against pandemic threats. The J&J Centers for Global Health Discovery are the latest chapter in our efforts to turn science into solutions for diseases that continue to threaten communities …

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Vaccine panel postpones vote on J&J COVID-19 vaccine

A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine.

The CDC and FDA announced on April 13 their recommendation to pause the vaccine’s use on safety grounds.

The Advisory Committee on Immunization Practices (ACIP) could ultimately help the CDC decide whether to continue using the vaccine, constrain it or discontinue it altogether.

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

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FDA advisory panel endorses J&J’s single-dose COVID-19 vaccine

The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.

Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.

The agency will likely authorize the vaccine quickly.

J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.

While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.

VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some member…

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Is J&J’s COVID-19 vaccine linked to tinnitus? 

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

J&J concluded that the tinnitus reports were likely unrelated to the vaccine. The principal investigator in the trial that two of the events were related and the remainder unrelated.

A 21-year-old volunteer involved in an earlier clinical trial for the J&J vaccine developed tinnitus and sudden hearing loss 34 days after receiving the vaccine. The patient recovered 69 days after receiving the injection. Johnson & Johnson also determined that the event was unrelated to the vaccine.

In all, some 43,783 volunteers participated in the Phase 3 trial. A total of 19,630 participants received the Ad26.COV…

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