Minocycline

Autolus Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

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fredag, maj 17, 2024
Conference call, UCL, Cardinal Health, Marketing, European Medicines Agency, CD19, FDA, EHA, Multiple myeloma, GD2, Immunotherapy, Research, Flow cytometry, Information technology, University College London, Cardinal, SLE, Conference, BioNTech, MIA, ACS Chemical Biology, MAA, ASH, Clinical trial, Bone marrow, Trial of the century, Nucleus, ADS, ASCO, SME, Minocycline, Marketing Authorisation Application, BCMA, Society, European Hematology Association, Canadian Aviation Regulations, Patient, Nature Communications, T cell, Quarter, Therapy, Engineering, Autoimmune disease, PDUFA, ALL, EMA, TRBC, Abstract, BLA, GMP

Two patients have been enrolled and Autolus continues to expect initial clinical data in late 2024.

Key Points: 
  • Two patients have been enrolled and Autolus continues to expect initial clinical data in late 2024.
  • Enrollment of the initial cohorts are complete and further updates from the MCARTY study are anticipated in H2 2024.
  • In April 2024, Autolus announced the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director.
  • Financial Results for the Quarter Ended March 31, 2024

Fortress Biotech Reports First Quarter 2024 Financial Results and Recent Corporate Highlights

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onsdag, maj 15, 2024
Amyloidosis, Doxycycline, HIV, NDA, FDA, Vaccination, CRL, New Drug Application, Bangladesh Technical Education Board, Gout, Infection, Erythema, Mustang, Fortification, Inflammation, Fortress Biotech, Hyperuricemia, AstraZeneca, IGA, Disease, Allopurinol, Food, Red, Dotinurad, Safety, Liver transplantation, Carcinoma, Cytomegalovirus, CMV, Minocycline, CKPT, Patient, Exercise, Radiation, PDUFA, Dermatology, Menkes disease, Rosacea, Mortality, BLA, URAT1, Pharmaceutical industry

MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2024.

Key Points: 
  • In January 2024, Fortress raised gross proceeds of approximately $11.0 million in a registered direct offering priced at-the-market under Nasdaq rules.
  • Fortress’ consolidated net revenue totaled $13.0 million for the first quarter ended March 31, 2024, all of which was generated from our marketed dermatology products.
  • Consolidated research and development expenses including license acquisitions totaled $24.8 million for the first quarter ended March 31, 2024, compared to $39.5 million for the first quarter ended March 31, 2023.
  • Consolidated selling, general and administrative costs were $17.9 million for the first quarter ended March 31, 2024, compared to $25.3 million for the first quarter ended March 31, 2023.

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

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torsdag, mars 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

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måndag, mars 18, 2024
Entrepreneurship, Capsule, Patient, Food and Drug Administration, Rosacea, NDA, Red, Minocycline, Erythema, Food, Marketing, FDA, CEA, Physician, IGA, PDUFA, Pharmaceutical industry

The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024.
  • The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues.
  • DFD-29 demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment (IGA) treatment success as well as the reduction in the total inflammatory lesion count in both studies.
  • For the secondary endpoint evaluating erythema (redness) associated with rosacea, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.”

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

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torsdag, mars 14, 2024
Nucleus, Bone marrow, BCMA, BioNTech, B-ALL, Patient, ALL, SLE, Engineering, Minocycline, European Medicines Agency, Therapy, Research, Canadian Aviation Regulations, Flow cytometry, ASH, General counsel, Immunotherapy, SVP, EMA, Legal Affairs, Trial of the century, GMP, SME, BLA, Nature Communications, Development, UCL, Biologics license application, Multiple myeloma, MIA, University College London, Senior, TRBC, GD2, ASCO, FDA, CD19, Conference call, Conference, MAA, EHA, ADS, MHRA, T cell, ACS Chemical Biology, PDUFA, Autoimmune disease, Pharmaceutical industry

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.

Key Points: 
  • “For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.
  • In February 2024, Autolus promoted Dr. Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel.
  • Dr. Leiderman brings extensive transactional and financial expertise, and Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’ Board.
  • Financial Results for the Year Ended December 31, 2023

Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting

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måndag, mars 11, 2024
American Academy of Dermatology, Microbiota, Marketing, FDA, U.S. FDA, Skin, Forehead, Entrepreneurship, Risk, AAD, Safety, GI, Red, Rosacea, Minocycline, Patient, Clinical trial, Erythema, Vagina, Microbiology, American Academy

SCOTTSDALE, Ariz., March 11, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.

Key Points: 
  • The clinical trial also assessed the safety and tolerability of the treatment.
  • The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical.
  • Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study.
  • Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462 .

Autolus Therapeutics announces publication in ACS Chemical Biology

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tisdag, januari 23, 2024
Therapy, Cytokine, Autoimmunity, Cancer, Minocycline, Safety, Toxicity, Vaccine

However, cell therapies have the capacity to engraft and function autonomously, making it challenging to modulate potency or toxicity by adjusting administration or dosage.

Key Points: 
  • However, cell therapies have the capacity to engraft and function autonomously, making it challenging to modulate potency or toxicity by adjusting administration or dosage.
  • Developing methods for remotely and precisely controlling the activity of cellular therapies in a tuneable and reversible way is desirable.
  • Most control systems use either small molecules with considerable concomitant pharmacologic effects, or unlicensed/difficult to obtain small molecules.
  • Protein scientists at Autolus developed a single-domain antibody-based system where minocycline induces disruption of a protein-protein interaction.

Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

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fredag, januari 5, 2024
Marketing, National Rosacea Society, Entrepreneurship, Food, CEA, Minocycline, Rosacea, FDA, Capsule, NDA, Red, New Drug Application, Face, Patient, Food and Drug Administration, Erythema, Pharmaceutical industry

SCOTTSDALE, Ariz., Jan. 05, 2024 (GLOBE NEWSWIRE) --  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 has submitted a New Drug Application (“NDA”) to the FDA seeking approval for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.

Key Points: 
  • DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.
    “This NDA submission is a significant milestone for Journey Medical and we look forward to collaborating with the FDA during its review to bring DFD-29, a potentially differentiated, best-in-class oral rosacea treatment, one step closer to patients.
  • The NDA submission is supported by positive data from Journey Medical’s two DFD-29 Phase 3 clinical trials for the treatment of rosacea.
  • The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues.
  • DFD-29 has the potential to become the only oral, systemic therapy to address both inflammatory lesions and erythema (redness) from rosacea, as demonstrated in the clinical trials.

Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters

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tisdag, januari 2, 2024
ITT, Patient, IDSA, Minocycline, MLT, Control, Safety, Pharmaceutical industry

CRANFORD, N.J., Jan. 2, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has completed enrollment in its pivotal Phase 3 clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. A total of 109 catheter failure events were observed in the event-based trial; a minimum of 92 catheter failure events were required to complete the trial. The study enrolled 241 patients at clinical sites in the U.S. and India.

Key Points: 
  • A total of 109 catheter failure events were observed in the event-based trial; a minimum of 92 catheter failure events were required to complete the trial.
  • The study enrolled 241 patients at clinical sites in the U.S. and India.
  • "Completing enrollment in our pivotal Phase 3 trial is a crucial milestone in the development of Mino-Lok, bringing us closer to addressing the limitations of the current standard of care for patients with catheter related blood stream infections (CRBSI).
  • We extend our deepest appreciation to the patients, investigators, and healthcare professionals who have been integral to the successful enrollment of this trial," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.

Elutia Submits CanGarooRM® Antibiotic-Eluting Biomatrix for FDA Clearance

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måndag, december 18, 2023
Neurostimulation, Food, Research, FDA, Minocycline, Rifampicin, Infection, Patient, Medical device

SILVER SPRING, Md., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®. Tailored for use with cardiac implantable electronic devices (CIEDs), such as pacemakers and internal defibrillators, CanGarooRM addresses a $600 million market, currently served by only one competitor. The decision to file came after the Company received feedback from a pre-submission meeting with the FDA. The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.

Key Points: 
  • SILVER SPRING, Md., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®.
  • The decision to file came after the Company received feedback from a pre-submission meeting with the FDA.
  • The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.
  • “We believe the clearance of CanGarooRM will be a transformational event for Elutia and allow patients to thrive without compromise,” said Dr. Randy Mills, President and CEO of Elutia.