Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL). In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic…
Evotec enters drug discovery alliance with Janssen
Evotec SE (Nasdaq:EVO) announced that it will work with Janssen Pharmaceutica NV, a subsidiary of the Janssen Pharmaceutical Companies (NYSE:JNJ), to identify drug targets and to partner on hit identification and lead optimization of chemical assets. The partnership will center around Evotec’s end-to-end drug discovery and development platform. “We are very proud to enter into…
Tremfya shows durable efficacy for psoriatic arthritis joint and axial symptoms
Janssen (NYSE:JNJ) has released new data showing the efficacy of the IL-23 inhibitor Tremfya (guselkumab) for a variety of psoriatic arthritis (PsA) symptoms for up to two years. Patients with active psoriatic arthritis treated with guselkumab in Phase 3 studies had consistent, long-term efficacy over two years. Specifically, patients who received the drug had improvements…
Janssen touts positive Tremfya and Stelara data for IBD at Digestive Disease Week
Johnson & Johnson’s (NYSE:JNJ) Janssen unit announced new Phase 2 GALAXI 1 data at Digestive Disease Week (DDW), showing substantial rates of clinical-biomarker and endoscopic response and clinical remission through 48 weeks of Tremfya (guselkumab) therapy for Crohn’s disease. The company also announced long-term pooled safety analyses for Stelara (ustekinumab) at the DDW event May…
Janssen’s company group chairman dishes on growth strategy
In 2021, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical segment Janssen reported revenue of more than $50 billion in fiscal 2021 and operational growth of 13.1%. Janssen exec Tom Cavanaugh’s next big goal for Janssen is ensure Janssen is a $60 billion pharmaceutical company by 2025. Heavy reliance on R&D will get them there, said Cavanaugh — Janssen’s…
15 of the best pharma companies to work for
The pharmaceutical industry continues to see strong growth and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The best pharma companies to work for continue to offer a number of advantages to skilled workers. Pharma positions remain in high demand, and…
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).…
Pharma’s top 20 R&D spenders in 2021
If 2020 underscored the importance of the pharma industry’s social importance, 2021 demonstrated the industry’s ability to translate R&D spending into profitable commercialized products. But while strong demand for COVID-19 therapies in 2021 provided unprecedented revenue levels for a handful of Big Pharma companies, it didn’t result in substantial changes in R&D spending. (Look out…
Janssen looks to win new indication in Europe for Imbruvica for untreated mantle cell lymphoma
Johnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL). The indication would cover patients who are not suitable for autologous…
Janssen’s pathway strategy shows promise for people with inflammatory bowel disease
Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease. Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet…
Network meta-analysis ranks guselkumab best for skin clearance in psoriatic arthritis
A recent comprehensive network meta-analysis (NMA) concluded that Tremfya (guselkumab) from Janssen (NYSE:JNJ) ranked highest for the overall level of skin clearance among 23 treatment regimens for active psoriatic arthritis (PsA). The NMA drew on data from 33 Phase 3 randomized clinical trials. Of those, 15 were targeted PsA therapies such as the IL-23p19 inhibitors such…
Janssen files for European authorization of bispecific antibody teclistama for multiple myeloma
Janssen (NYSE:JNJ) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of a T-cell redirecting, bispecific antibody to treat relapsed or refractory multiple myeloma (RRMM). Known as teclistamab (JNJ-64007957), the bispecific antibody targets the B-cell maturation antigen (BCMA) and CD3.1. In December 2021, Janssen submitted a Biologics License Application…
Leyden Labs closes $140M in Series B funding
After announcing a licensing deal for CR9114, a monoclonal antibody for influenza A and B from Janssen (NYSE:JNJ), Leyden Labs has won $140 million in Series B funding. Amsterdam-based Leyden Labs plans on developing an intranasal spray based on CR9114. Leading the round were Casdin Capital and GV (formerly Google Ventures). Leyden plans on using…
Leyden Labs licenses monoclonal antibody for influenza A and B from 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 to…
Blood thinner Xarelto now has 11 indications; here’s a look at the latest two
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…
Janssen’s latest Tremfya data could offer hope for subset of psoriatic arthritis
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…
Xarelto wins two additional pediatric indications
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 EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients
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 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).…
ConcertAI integrates with imaging technology specialist TeraRecon
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…
Janssen’s global head of R&D opens up on CAR-T research, data science and more
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 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.…
Why FDA optimized for flexibility with COVID-19 vaccine booster choice
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…
Lancet study could bode well for mix-and-match COVID-19 vaccination
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…
VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters
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.…