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J&J joins Moderna and Pfizer in researching Omicron variant

Johnson & Johnson (NYSE:JNJ) has announced that it is collaborating with academic institutions internationally to gauge the effectiveness of its COVID-19 vaccine against Omicron and other SARS-CoV-2 variants.

In particular, J&J said it is conducting research on blood serum from clinical trial volunteers who have received single or multiple doses of its COVID-19 vaccine.

The company also vowed to design and develop an Omicron-specific variant vaccine if necessary.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Dr. Mathai Mammen, global head, Janssen Research & Development, in a press release. “Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real-world effectiveness studies being conducted with the J…

Janssen upbeat about latest guselkumab data for patients with psoriatic arthritis

Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).

Guselkumab first won FDA approval in 2017 for treating moderate-to-severe plaque psoriasis. The drug became the first interleukin (IL)-23 inhibitor to win an FDA indication for active PsA in 2020.

“We at Janssen are committed to this IL-23 pathway and understanding how it is driving disease,” said Dr. Alyssa Johnsen, vice president, rheumatology and maternal-fetal immunology disease area leader at Janssen. The pathway is “very important for psoriatic arthritis and psoriasis, and we continue to investigate where it might be able to help patients and add…

California and Colorado to allow COVID-19 boosters for all adults

Flag images courtesy of Wikipedia.

COVID-19 vaccine booster eligibility has gradually expanded, but a significant portion of adults don’t meet the current criteria set forth by FDA and CDC.

California and Colorado have decided to sidestep the federal government by making all fully vaccinated adults in those states eligible for a booster.

California will require that six months have elapsed in order for recipients of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines to receive a third dose. Similarly, recipients of the J&J vaccine must wait at least two months before receiving the second dose of that vaccine. Both requirements mirror federal recommendations except for the provision that all fully vaccinated adults are eligible.

Now facing a significant wave of COVID-19 infections, Colorado is also making boosters available for all fully vaccinated adults.

In an…

Janssen’s global head of R&D opens up on CAR-T research, data science and beyond

Johnson & Johnson’s Janssen division (NYSE:JNJ) was among the first drug companies to prioritize oncology research.

The company has more than three decades of experience in the domain. Recently, CAR-T therapy has become “one of the most exciting areas of research for cancer and other diseases for the company, said Mathai Mammen, global head of R&D for Janssen, in a recent interview.

In the following Q&A, Mammen provides an overview of the company’s CAR-T research while also touching on its work to revise the treatment of epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). He also touches on new potential indications for Nipocalimab, a fully-human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody, and dishes on the company’s investment in data science in the development of drugs and vaccines.

Drug Discovery & Development: Could you provide a brief overview of Janssen’s work on CAR-T (including ciltacabt…

Janssen shares new positive Stelara data for Crohn’s disease and ulcerative colitis

Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD).

The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr. Jan Wehkamp, vice president, gastroenterology disease area leader, Janssen Research & Development, in an interview.

In a separate analysis, Stelara led to more persistent therapeutic effects than Humira (adalimumab) at 12 months in bio-naive CD patients. Janssen gathered the CD data from de-identified health insurance claims.

Janssen presented the data, based on new modeling and real-world evidence analyses, at the American College of Gastroenterology Annual Scientific Meeting (ACG).

First-line Stelara patients with moderately to severely active UC tended to have a…

CDC authorizes fourth COVID-19 vaccine dose for some immunocompromised patients

As a growing number of Americans become eligible for a third dose of COVID-19 vaccines, CDC continues to expand its booster guidelines.

The agency has amended its criteria for moderately to severely immunocompromised people to allow a fourth dose of COVID-19 vaccine six months after receiving the third dose.

The criteria pertain to immunocompromised individuals who are 18 years of age or older who have received three doses of an mRNA vaccine.

CDC will allow COVID-19 vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX), Moderna (NSDQ:MRNA) or Janssen (NYSE:JNJ) for the fourth dose. For Moderna recipients, the guidance recommends a 100-µg dose of mRNA for the third dose and a 50-µg dose for the fourth.

The guidelines, however, are more overt in their recommendations for moderately or severely immunocompromised individuals who have only received two doses of an mRNA vaccine. Assuming at least 28 days have elapsed since the second dose, CDC recommends t…

Lancet study could bode well for mix-and-match COVID-19 vaccination

[Image by Sam Moqadam on Unsplash]

The mRNA vaccines from Pfizer-BioNTech and Moderna appear to work well as a second dose in recipients of a single dose of the AstraZeneca AZD1222 vaccine.

A report in Lancet found that two doses of AstraZeneca’s AZD1222 vaccine were 50% effective. Recipients who received a dose of the AZD1222 vaccine followed by a dose of Moderna’s mRNA-1273 vaccine had adjusted vaccine effectiveness of 79%. Those who received an initial dose of AZD1222 followed by the Pfizer-BioNTech BNT162b2 vaccine saw vaccine effectiveness of 67%.

The report authors stopped short of claiming that a heterologous AZD1222 and mRNA prime-boost vaccination strategy is superior, concluding that it “may be an effective alternative to increase population immunity against COVID-19.”

“These results could have important implications for vaccination strategies and consequently in the battle against the…

VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters

Image from Sam Moqadam on Unsplash

The U.S. appears to be on the verge of expanding the use of COVID-19 vaccine boosters after an advisory committee backed boosters for the Johnson & Johnson (NYSE:JNJ) and Moderna (NSDQ:MRNA) vaccines.

On October 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products for high-risk populations.

The committee’s guidance for the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech (NYSE: PFE/NSDQ:MRNA) was to allow boosters six months after completion of a primary series.

Conversely, VRBPAC recommended that recipients of the single-dose Janssen vaccine receive a booster at least two months after the initial dose.

Several panelists balked at the word “booster” in reference to the Janssen vaccine, arguing that would be more accurate to refer to it as a two-dose va…

Janssen presents new safety data for Stelara in older patients

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials.

The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from 13 clinical trials across approved indications, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The analysis included data for up to five years.

“This particular analysis builds on the complete data we have on the safety of Stelara over thousands of patients and literally dozens of clinical trials over 20 years now,” said Dr. Andrew Greenspan, vice president of medical affairs at Janssen Immunology.

The analysis is also noteworthy in its focus on patients 60 and older, Greenspan said.

“Often, we limit patients who are older from the clinical trials, and that’s not …

Janssen shares data on 6-month schizophrenia shot at ECNP

At the European College of Neuropsychopharmacology (ECNP), Janssen presented data on the Phase 3 trial for the recently approved schizophrenia treatment Invega Hafyera, paliperidone palmitate 6-month (PP6M).

“We hope that this continues to change the paradigm in treating schizophrenia with long-acting injectables,” said Dean Najarian, associate field director, neuroscience medical affairs at Janssen. “Non-adherence is a major contributor of relapses and associated hospitalizations, and certainly costly to the healthcare systems as well as social dynamics.”

The prospect of a six-month schizophrenia injection can “offer patients and caregivers the potential for a life less defined by their schizophrenia medication,” Najarian said.

Invega Hafyera is the only twice-yearly, long-acting injectable.

Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ), announced the FDA approval of the formulation on Sept. 1. Approvals in other countries are pending…

Janssen begins Phase 3 study for RSV vaccine in adults 60 and older

After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine.

RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually.

The global EVERGREEN study will enroll roughly 23,000 adults 60 years of age and older.

“Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults,” said Dr. Penny Heaton, global therapeutic area head, vaccines at Janssen Research & Development.

Currently, no vaccines are available for RSV, although several are in development.

FD…

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,…