Janssen

Janssen (NYSE JNJ) and Leyden Labs (Amsterdam) have signed a licensing agreement that gives the latter rights to develop CR9114, an antibody protecting against influenza A and B. Leyden hopes to commercialize CR9114 as a nasal spray. Under the terms of the deal, Janssen will get an upfront payment and could receive milestone payments tied…

Last December,’s (NYSE:JNJ) blockbuster blood thinner Xarelto (rivaroxaban) won FDA approval for two new indications for pediatric indications. The drug now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC). In 2020, the drug generated nearly $6.5 billion in revenue globally. To learn more about the new indications, we spoke…

Psoriatic arthritis (PsA) is a complex heterogeneous disease involving the peripheral joints, affecting between 7% and 26% of psoriasis patients. Among the popular treatment options for psoriasis are tumor necrosis factor (TNF) inhibitors. A significant portion of psoriatic arthritis patients, however, fail to respond to TNF inhibitors.  Janssen announced last month that Tremfya (guselkumab) fared…

Janssen (NYSE:JNJ) has received FDA approval for two new indications for the blockbuster blood thinner Xarelto (rivaroxaban). The first new indication relates to treating venous thromboembolism (VTE, or blood clots) and reducing the risk of recurrent VTE in pediatric individuals from birth to less than 18 years after at least five days of parenteral anticoagulant…

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Rybrevant is a fully-human EGFR-MET bispecific antibody. NSCL is responsible for the majority of lung cancers. The Conditional Marketing Authorisation (CMA) covers patients who have failed…

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).…

Privately-held ConcertAI has formally integrated with TeraRecon, a provider of advanced visualization services, including 3D and 4D medical imaging post-processing.  Cambridge, Massachusetts–based ConcertAI says the integration will expand its offerings for life science companies, which now can integrate data from electronic medical records, genomic data and medical imaging. As a result, the company can offer…

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, Chimeric antigen receptor (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…

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.…

Early data seem to suggest that mRNA vaccine boosters are more effective than additional doses of the adenovirus-vector COVID-19 vaccines from AstraZeneca and Johnson & Johnson. But scientists don’t currently have “any real clinical effectiveness data on this question,” said Dr. Janet Woodcock, acting FDA commissioner. To date, vaccine developers have heavily relied on antibody…

The mRNA vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) appear to work well as a second dose in recipients of a single dose of the AstraZeneca (LON:AZN) 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…

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 Oct. 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products.…

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…

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…

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…

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…

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.  In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity…

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of…

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…

Traditionally, one of the most challenging aspects of treating schizophrenia is medication adherence. Patients who neglect to take their medicine have an elevated risk of relapse, hospitalization and suicide. “There’s a higher likelihood of an exacerbation of the illness occurring,” said Dr. Gustavo Alva, medical director at ATP Clinical Research (Costa Mesa, California).  The problem…

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types. ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together…

A few decades ago, an HIV diagnosis was akin to a death sentence. But with proper treatment including antiretroviral therapy, HIV patients can often expect to have a normal life expectancy. David Jimenez, former president of Johnson & Johnson’s Janssen Infectious Diseases, is confident that similar breakthroughs can happen in pulmonary hypertension. “We’re not there…

The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.” WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients: Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year,…

A post-hoc analysis published in Lancet Rheumatology suggested that Janssen’s IL-23 inhibitor Tremfya ​​(guselkumab) is effective in treating psoriatic arthritis (PsA) patients with symptoms affecting the spine and sacroiliac (SI) joints. In addition, the patient subset had sustained improvement through 52 weeks. The study focused on psoriatic arthritis patients in the company’s Phase 3 DISCOVER-1 and DISCOVER-2…

Janssen’s Tremfya (guselkumab) was associated with reduced fatigue in two Phase 3 clinical trials involving 1,120 patients with psoriatic arthritis (PsA), according to an article published in Arthritis Research & Therapy. The study found that PsA patients who received 100 mg of guselkumab every four weeks or every eight weeks had clinically meaningful and sustained improvements…