TREMFYA® (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, Meets Primary Endpoints of Superior ACR20 Responses versus Placebo at Week 24 in Phase 3 Psoriatic Arthritis Studies
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 24-week Phase 3 data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with TREMFYA® (guselkumab) achieved at least a 20 percent improvement in disease signs and symptoms (American College of Rheumatology ACR20 response) compared to placebo. These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies, which were designed to evaluate the efficacy and safety of investigational use of TREMFYA for the treatment of adult patients with active PsA. These data were presented as part of an oral plenary session (abstract 0807) and a late-breaking poster session (abstract L13), respectively, at the American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) 2019 Annual Meeting taking place November 8-13 in Atlanta. Janssen presented more than 30 abstracts at the meeting.
New Analysis from Landmark CREDENCE Study Shows the Efficacy and Safety Profiles of INVOKANA® (canagliflozin) are Consistent Across Various Levels of Kidney Function
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results of an important new analysis from the landmark Phase 3 CREDENCE study, which found that INVOKANA® (canagliflozin) consistently reduced the risk of renal and cardiovascular (CV) events in patients with various levels of kidney function, or estimated glomerular filtration rates (eGFR*). This analysis showed that INVOKANA® provides a strong, consistent safety profile and efficacy at all tested eGFR levels. Specifically, greater renal absolute benefits were observed in those with the most advanced renal insufficiency (eGFR <60 mL/min/1.73 m2). Results from this secondary analysis were presented today in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2019 and build on the positive primary results from the Phase 3 CREDENCE study.
Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data for Investigational Hepatitis B Regimens at The Liver Meeting(R) 2019
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced Phase 2 clinical data on a double combination of JNJ-3989 (formerly ARO-HBV) and a nucleos(t)ide analog (NA), and the first clinical data on a triple combination of JNJ-3989, JNJ-6379, and an NA, with collaborator Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data is being presented in two poster presentations at The Liver Meeting(R), the Annual Meeting of the American Association for the Study of Liver Disease (AASLD).
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to expand the IMBRUVICA® (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The submission is based on positive results from the investigational Phase 3 E1912 study designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the National Institutes of Health. The study met the primary endpoints of progression-free survival (PFS) and overall survival (OS) in patients aged 70 years or younger treated with IMBRUVICA plus rituximab, compared to the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). Results from the study were presented at the 2018 American Society of Hematology (ASH) Annual Meeting and were recently published in The New England Journal of Medicine August 2019 issue.
CARLSMED Expands Executive Team Naming COO
CARLSMED, Inc., a San Diego-based medical technology company, today announced the appointment of Sharon Schulzki as Chief Operating Officer (COO). Ms. Schulzki has deep experience building venture backed MedTech startups and has excelled in prior executive leadership roles with market leaders Stryker and Johnson & Johnson's DePuy Synthes. She most recently led the exit of the 3D printing medical technologies company Tissue Regeneration Systems (TRS) to J&J DePuy Synthes and the licensing of TRS's proprietary mineral coating technology to Medtronic Spine.
Bavarian Nordic Announces Submission of European Marketing Authorisation Applications for Investigational Ebola Vaccine Regimen
COPENHAGEN, Denmark, November 7, 2019 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that its partner Janssen Pharmaceutical Companies of Johnson & Johnson have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN(R) Filo). In September 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment, which will shorten the review time for these applications.
Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen's Investigational Ebola Vaccine Regimen
Johnson & Johnson today announced that its Janssen Pharmaceutical Companies have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus species. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). In September 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment for these applications.
Janssen to Present Latest Research from Robust Blood Cancer and Cardiovascular Disease Portfolios at this Year's American Society of Hematology Annual Meeting
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 46 company-sponsored and more than 30 investigator-led abstracts will be presented at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, December 7-10. Highlights include 13 oral presentations with new data for the BCMA-targeted CAR-T therapy JNJ-68284528 (JNJ-4528) in multiple myeloma; the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) in multiple myeloma; the Bruton's tyrosine kinase (BTK) inhibitor IMBRUVICA® (ibrutinib) in B cell malignancies; and the Factor Xa inhibitor XARELTO® (rivaroxaban) for the reduction in the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients at risk, including for patients with cancer.
Innovative Biotechs Look to Tackle Ocular Ailments
Visual impairment is one of the most common health conditions that negatively impact millions of Americans' physical and mental health. Visual impairment is defined as 20/40 vision, or worse, in the better eye even with eyeglasses, according to the American Academy of Ophthalmology. Minor eye impairment conditions such as astigmatism aren't significantly serious and therefore do not necessarily mean a person has "bad eyes," according to the Kellogg Eye Center of the University of Michigan. On the other hand, serious eye conditions such as glaucoma can become detrimental if the damage continues to persist. Notably, glaucoma is one of the most common ophthalmic disorders encountered in primary and secondary care. Glaucoma is classified as a group of eye conditions that damage the optic nerve, which is vital for optimal eye vision, according to the Mayo Clinic. The damage is commonly caused by an abnormally high pressure buildup in the eye. Unfortunately, many forms of glaucoma do not have early warning signs and can ultimately lead to vision loss or complete blindness. Additionally, glaucoma generally affects older adults, but it can occur at any age. As such, approximately three million Americans are affected by glaucoma, but the number is also expected to soar to four million by 2030, according to the Glaucoma Research Foundation. And despite the number of treatments available, medical practitioners are continuously working to develop new therapies to effectively aid patients suffering from glaucoma. According to data compiled by Fortune Business Insights, the global glaucoma therapeutics market was valued at USD 6.27 Billion in 2018. By 2026, the market is expected to reach USD 10.09 Billion while registering a CAGR of 6.1%. Q BioMed Inc. (OTC: QBIO), Johnson & Johnson (NYSE: JNJ), Allergan plc (NYSE: AGN), Bausch Health Companies Inc. (NYSE: BHC), Aerie Pharmaceuticals, Inc. (NASDAQ: AERI)