JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES

The programme changes were reflected in a pipeline list on the company’s website. Image credit: Shutterstock/MichaelVi. Johnson and Johnson (J&J) has cleaved several clinical programmes, including a Phase II study evaluating seltorexant in patients with probable Alzheimer’s disease. Trials have been cut across the company’s portfolio, with its neuroscience pipeline the most affected, losing two Phase II programmes and a Phase I candidate. J&J has not released any information on its asset prioritisation, with the changes reflected in a pipeline list on the company’s website, as first reported by Endpoints News . “We regularly prioritise programs in our portfolio to ensure sustainable delivery of transformative medicines to patients with unmet needs,” a J&J spokesperson told Pharmaceutical Technology . Seltorexant is one of J&J’s most promising neuroscience candidates. The human orexin-2 receptor selective agonist produced positive results in a Phase III trial earlier this year as an adjuvant treatment to antidepressants in 588 patients with major depressive disorder (MDD) with insomnia symptoms. The company had been evaluating seltorexant in a Phase II study (NCT05307692) in 70 patients with probable Alzheimer’s Disease (AD) and clinically significant agitation/aggression. The randomised, placebo-controlled, double-blind study’s status on ClinicalTrials.gov had changed in March this year from “recruiting” to “completed”. See Also: MHRA puts technology in the spotlight in 2024/25 business plan Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production The Phase II cut in Alzheimer’s puts a question mark against the lofty heights J&J had envisaged for seltorexant. Less than a year ago, the company said the drug could reach blockbuster status, forecasting peak sales between $1bn and $5bn. The projections were, however, driven by the drug’s potential approval in depression, rather than Alzheimer’s disease. GlobalData’s Pharma Intelligence Centre currently forecasts seltorexant sales of $610m by 2030. GlobalData is the parent company of Pharmaceutical Technology . Also on the chopping board in J&J’s neuroscience section is the Phase I Parkinson’s treatment JNJ-0376 and Phase II P2X7 antagonist JNJ-55308942. J&J had shared very little about JNJ-0376 – one of its few mentions coming in a 2023 presentation under early-stage neuroscience pipeline targets with “novel mechanisms” to treat neurodegenerative disorders. JNJ-55308942, meanwhile, was being studied in patients with bipolar disorder in a major depressive episode. The randomised Phase II study (NCT05328297) enrolled 116 patients and was marked as “completed” in July this year. Outside of neuroscience-related assets, J&J has also tossed its early-stage psoriasis candidate, JNJ-1459. Earlier this year, the company halted trials of the epilepsy drug ADX71149 being developed in partnership with Addex Therapeutics following a Phase II failure. The pipeline trim comes at the same time J&J reported strong Q3 financial results for 2024. Sales of the company’s oncology drugs jumped nearly 19%, with multiple myeloma treatment Darzalex (daratumumab and hyaluronidase-fihj) doing much of the heavy lifting. The immunotherapy drug brought in more than $3bn, helping the big pharma turn a 5.2% year-over-year growth.

Winston-Salem based digital health company will showcase its technology at world-famous HLTH Conference WINSTON-SALEM, N.C., Oct. 14, 2024 /PRNewswire/ -- mPATH® Health, a digital health company dedicated to improving cancer screening, has been selected as a showcase company for the National Cancer Institute's (NCI) Small Business Innovation Research (SBIR) Investor Initiatives program. As part of this program, mPATH has been invited to showcase its technology at the annual HLTH Conference, the world's number one event for healthcare innovation, in Las Vegas, NC, on October 20-23, 2024. Continue Reading Awardees were chosen through a competitive application process by a team of 60 venture capitalists and strategic partners including Johnson and Johnson and GE Healthcare. The selection committee chose 30 showcase companies out of an application pool of 100. Selection to the NCI SBIR Investor Initiatives Program provides companies with invaluable opportunities to connect with new investors, collaborate with leaders in healthcare technology and access resources in NCI's network of healthcare innovators and strategic advisors. mPATH Health selected as a showcase company for the NCI's Investor Initiates program at HLTH in Las Vegas on 10/20/24. Post this "Being selected for the Investor Initiatives Program is a great honor," said Dr. David Miller, CEO and Founder of mPATH Health. "We developed mPATH to increase the uptake of preventive screening tests and save lives. Being featured as an NCI showcase company at the HLTH Conference will help us form the strategic partnerships needed to reach this goal faster." As part of this program, mPATH will showcase at the NIH pavilion at the HLTH Conference October 20-23, 2024 in Las Vegas, NV. The HLTH Conference is the world's preeminent event for healthcare innovation, with an average attendance of 12,000 from across the world of healthcare technology, investment and research. "We are thrilled to have mPATH Health featured in the NCI Investor Initiative Program at HLTH 2024," said Rich Scarfo, President of HLTH. "HLTH continues to connect industry leaders and serve as the global platform for healthcare innovation, and it is companies like mPATH that showcase the transformative potential of digital health technologies in saving lives and advancing preventive care." About mPATH Health mPATH Health is a digital health company dedicated to transforming preventive cancer screening by integrating automation and behavioral science. By leveraging cutting-edge technology and personalized outreach, mPATH empowers individuals to prioritize their health and undergo regular screenings for early cancer detection. For more information, visit . About The National Cancer Institute (NCI) NCI is the federal government's principal agency for cancer research and training. NCI is one of 11 agencies that make up the Department of Health and Human Services (HHS). Learn more at . Media contact Cassie Allen mPATH Head of Commercial Development (919) 675-4949 [email protected] SOURCE mPATH Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The European Commission has approved Johnson and Johnson’s Yuvanci for pulmonary arterial hypertension, offering the first single-pill treatment option to European patients. Credit: andreswd via Getty Images. The European Commission (EC) has approved Johnson and Johnson’s Yuvanci (macitentan + tadalafil) for the treatment of pulmonary arterial hypertension (PAH). The approval marks Yuvanci as the only single-tablet combination therapy available for patients with PAH. PAH is a rare, progressive disorder in which patients have high blood pressure in the pulmonary arteries for no apparent reason. Current treatment for PAH involves first-line dual combination therapy with macitentan and tadalafil for patients without cardiopulmonary comorbidities. This currently consists of a multi-pill regimen. “This can deeply impact their [PAH patients’] daily lives as they might struggle to maintain adherence to their treatment regimen,” said Dr. Tamara Werner-Kiechle, the Europe, Middle East, and Africa (EMEA) therapeutic area lead for neuroscience and cardiopulmonary drugs at Johnson & Johnson Innovative Medicine in a 30 September press release. Johnson and Johnson has developed the Yuvanci as a substitution therapy for the long-term treatment of PAH in adults of the World Health Organization’s (WHO) Functional Class (FC) II to III. This includes patients with PAH that causes a slight limitation in physical activity, yet they are still comfortable at rest, and “patients with marked limitations to physical activity”, as per WHO. Patients will need to have already been treated with a two-pill combination of macitentan and tadalafil to be eligible for Yuvanci. Johnson and Johnson currently markets macitenan monotherapy under the brand name Opsumit, whilst Eli Lilly sells tadalafil as Cialis for PAH. The approval is based on data from the Phase III A DUE study (NCT03904693) , which also led to a positive recommendation for Yuvanci’s approval by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products in July. The pharmaceutical giant presented data from the Phase III A DUE clinical study at the American College of Cardiology’s 72nd Annual Scientific Session. In the double-blind study, Yuvanci-treated patients showed significant improvements in the co-primary endpoints of pulmonary vascular resistance (PVR) and pulmonary haemodynamic improvement. Patients who took the combination therapy demonstrated a 44% decrease in PVR compared to a 22% decrease in the Adcirca monotherapy group. See Also: Almac Group North American Headquarters Expansion, Pennsylvania, USA LOTTE BIOLOGICS’ East Syracuse Pharmaceutical Manufacturing Facility, US Opsumit is an endothelin receptor antagonist that treats PAH by inhibiting pathways related to vasoconstriction, fibrosis and proliferation. Meanwhile, Cialis is a phosphodiesterase type-5 inhibitor that treats the disorder by increasing cGMP, leading to a relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed. Johnson and Johnson submitted a new drug application to the US Food and Drug Administration (FDA) for Yuvanci in May 2023, receiving an approval for its submission in March 2024.