Janssen reports positive clinical trial data for its Xarelto to treat PAD effects

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto.

The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).

Data from two analyses reinforced the benefit of Xarelto by demonstrating positive effects delivered by the vascular dose in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. Xarelto significantly reduced hospitalizations due to thrombotic events in patients who underwent LER compared to patients who took aspirin alone, Janssen said in a news release.

Voyager PAD, a study of 6,564 patients across 542 sites in 34 countries, randomized patients at a 1:1 ratio for receiving the Xarelt…

Read more
  • 0

J&J expands it long-acting injectables partnership with Midatech

Midatech Pharma (Nasdaq:MTP) announced today that it extended its R&D collaboration with Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceuticals.

Cardiff, United Kingdom-based Midatech, a drug delivery technology company focused on the biodelivery and biodistribution of medicines, initially entered into the R&D collaboration with Janssen on July 21, 2020.

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

Read more
  • 0

CDC panel unanimously backs J&J and Moderna vaccine boosters 

CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose.

The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are immunocompromised and those who have frequent occupational or institutional exposure to SARS-CoV-2.

The recommendation for the Moderna boosters pertains to the 50-µg dose level, which is half the level used in the primary series.

CDC Director Dr. Rochelle Walensky will now decide whether to accept or alter the ACIP recommendations. For the Pfizer-BioNTech booster, Walensky opted to support boosters for a larger segment of people than the ACIP had recommended.

Walensky is likely to issue a final decision in the coming days.

The CDC advisors also recommended allowing Americans to ch…

Read more
  • 0

Johnson & Johnson to ask FDA to authorize COVID-19 booster

Johnson & Johnson’s Janssen division (NYSE:JNJ) is planning on requesting expanding the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters.

The previous EUA covered a single dose of the vaccine.

Despite its initial advantage as a single-dose vaccine, Ad26.COV2.S has failed to match the popularity of the mRNA vaccines from Pfizer and Moderna.

Authorities in the U.S. and EU have linked the vaccine to extremely rare blood clotting episodes. And recently, officials at the European Medicines Agency found another possible link between the vaccine and clotting in deep veins in Ad26.COV2.S recipients, Reuters reported.

A recent CDC study found that a single dose of the Janssen vaccine was 71% effective in preventing hospitalization from COVID-19. By contrast, the two-dose Moderna and Pfizer-BioNTech vaccines were 93% and 88% effective, respectively.

Janssen said an additional dose of Ad26.COV2.S vaccine b…

Read more
  • 0

Xarelto similar to aspirin in pediatric Fontan procedure study 

Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart.

Physicians have traditionally relied on aspirin (acetylsalicylic acid) to reduce the risk of thrombotic events following the Fontan procedure. Such thrombotic events are associated with significant morbidity and mortality.

The data, collected in the Phase 3 UNIVERSE trial, has been published in the Journal of the American Heart Association. The study concluded that “participants who received rivaroxaban for thromboprophylaxis [thrombosis prevention] had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the [acetylsalicylic acid] group.”

This summer, the Raritan,…

Read more
  • 0

CDC study finds waning immunity in Pfizer-BioNTech vaccine recipients after four months

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions.

The CDC concluded that, from March 11 to August 15, the Moderna vaccine was 93% effective. The Pfizer-BioNTech and Janssen vaccines had lower effectiveness rates of 88% and 71%, respectively. The research also found that post-vaccination anti-spike IgG and anti-RBD IgG antibodies levels were “significantly lower” for Janssen vaccine recipients than those who received mRNA vaccines

Drawing data from more than 3,600 adults, the study interpreted vaccine efficacy as protection against hospitalization.

The report noted that all three COVID-19 vaccines available in the U.S. prevented hospitalization based on data from 21 hospitals.

The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that inte…

Read more
  • 0

European regulators offer positive opinion on Janssen’s schizophrenia treatment

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation covers clinically stable adults on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.

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

Read more
  • 0

Janssen wins FDA approval of twice-yearly schizophrenia treatment 

Janssen (NYSE:JNJ) has won FDA approval for the long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), which will be the first six-month injectable on the U.S. market.

Titusville, New Jersey–based Janssen announced that patients who intend to obtain Invega Hafyera must receive Invega Sustenna (one-month paliperidone palmitate) four at least four months beforehand. Alternatively, they can receive at least one cycle of Invega Trinza (three-month paliperidone palmitate).

While medication nonadherence is a challenge in all chronic conditions, the problem is especially acute in schizophrenia, as a 2014 study in Patient Related Outcome Measures explained. Schizophrenia can lead to social isolation, stigma, substance abuse, depression and cognitive impairment, all of which can complicate adherence.

Janssen is confident that twice-yearly Invega Hafyera could help address the issue.

FDA approved Invega Hafyera after reviewing data from…

Read more
  • 0

Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001.

In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime dose.

Janssen noted robust increases in participants aged 18 to 55 and those 65 and older who received a reduced booster dose.

The company has submitted the data to the pre-print publisher medRxiv.

Johnson & Johnson had found earlier that the Ad26.COV2.S vaccine elicited significant protection against COVID-19 eight months after the initial vaccination. Those data were published in NEJM.

CDC said on August 18 that recipients of the Johnson & Johnson vaccine will likely benefit from a booster, but that more data are required.

The company i…

Read more
  • 0

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.

Read more
  • 0

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.

Read more
  • 0

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. 

Read more
  • 0