Journey Medical Successful Completion of Pre-NDA Meeting for Rosacea Therapy

 Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the Company received the official meeting minutes from its pre-New Drug Application (“NDA”) meeting with the FDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) to treat rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.

The purpose of the meeting was to discuss the 505(b)(2) NDA submission plan for DFD-29 for the treatment of inflammatory lesions (papules and pustules) and erythema of rosacea. During the pre-NDA meeting and in the official meeting minutes, the FDA agreed that the proposed data package is sufficient to support the NDA submission, which the Company continues to anticipate will occur around year-end of 2023.

https://www.globenewswire.com/news-release/2023/12/06/2791735/0/en/Journey-Medical-Corporation-Announces-Successful-Completion-of-Pre-NDA-Meeting-with-the-FDA-for-DFD-29-to-Treat-Rosacea.html

Sanofi to boost drug development spend by 700 mln euros in 2024

 Sanofi said it would spend close to 700 million euros ($754 million) more on drugs development next year, specifying for the first time an increase in costs that roiled investors and triggered a sell-off in the stock in late October.

Speaking on a media call ahead of an R&D investor event in New York on Thursday, CEO Paul Hudson said that a "steady state" of longer-term development expenses was likely between 700 million and 1 billion euros above the 2023 level.

https://finance.yahoo.com/news/sanofi-boost-drug-development-spend-124344680.html

Ipsen, Genfit priority review for New Drug Application for liver disease thrapy

 

• New Drug Application granted priority review with PDUFA date set for June 10, 2024

• European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor

• Investigational elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC) to be filed in E.U. and U.S. in nearly a decade

https://finance.yahoo.com/news/ipsen-confirms-u-fda-grants-101500040.html

Anixa to add Cohorts to Phase 2 of breast cancer vax trial

  Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense.

The data were presented at the 2023 San Antonio Breast Cancer Symposium by G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."

Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFNγ and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect. Data from the 16 patients treated to date showed that:

• The majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.
• 12 (75%) of the women had antigen-specific IFNγ and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher.
• A statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.
• Among the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).
• No significant side effects were observed, at the MTD, besides irritation at the sites of injection. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.

Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts.

• The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.
• The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies.

"The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine. Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors, and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC."

https://www.prnewswire.com/news-releases/anixa-biosciences-and-cleveland-clinic-present-positive-new-data-from-phase-1-study-of-breast-cancer-vaccine-302007568.html

Vanda Acquires U.S. and Canadian Rights to PONVORY® Approved for Relapsing MS

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY® has a proven safety profile with over 10 years of data.

"The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

In a clinical study, PONVORY® was shown to be superior to Aubagio®, another approved drug for multiple sclerosis (MS), in the annual rate of relapse and it was also associated with fewer T2 and T1 MRI lesions versus the comparator. Approximately 9 out of 10 people taking PONVORY® did not experience disability progression over 2 years (as measured by the time to 3-month Confirmed Disability Progression).1

The effect of PONVORY® on the decrease of circulating lymphocytes is reversible so lymphocytes quickly return to baseline levels after discontinuation of PONVORY®. This rapid reversible effect is important for people needing to pause therapy for a vaccine. For women of childbearing age who want to become pregnant, PONVORY® is eliminated from the body in about 7 days after stopping treatment.

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-acquires-us-and-canadian-rights-to-ponvory-ponesimod-a-selective-s1p1r-modulator-approved-for-patients-with-relapsing-multiple-sclerosis-302008402.html

Regenron Updated Data Demonstrated Strong Response in Multiple Myeloma

 71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up

Data to be submitted to regulatory authorities, with Biologics License Application on track to be submitted to the FDA this year

Regeneron to host virtual investor event to discuss results alongside updates across its hematology portfolio on Thursday, December 14 at 8:30 a.m. ET

https://www.globenewswire.com/news-release/2023/12/07/2792394/0/en/Updated-Linvoseltamab-Pivotal-Data-Demonstrated-Strong-Rates-and-Depth-of-Response-in-Patients-with-Heavily-Pre-Treated-Multiple-Myeloma.html

Hepion Pharmaceuticals Announces Restructuring Plan

 Restructuring program purpose is to preserve capital and optimize clinical development program

Management plans to continue to evaluate its Phase 2b ASCEND-NASH clinical trial taking in account current market environment

Cash runway extended into Q2 2025

https://www.globenewswire.com/news-release/2023/12/07/2792459/0/en/Hepion-Pharmaceuticals-Announces-Restructuring-Plan-to-Enhance-Shareholder-Value-and-Management-Changes.html