Macrolides

Synaptogenix Announces Conference Call to Discuss AAIC Abstract Findings

Retrieved on: 
Wednesday, July 21, 2021
Bryostatin, Macrolides, Total synthesis

The U.S. toll free dial-in for the conference call is (877) 407-9205, and the international dial-in number is 1-(201)-689-8054.

Key Points: 
  • The U.S. toll free dial-in for the conference call is (877) 407-9205, and the international dial-in number is 1-(201)-689-8054.
  • Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases.
  • Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease.
  • The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome.

U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients

Retrieved on: 
Tuesday, July 20, 2021
Medical specialties, Clinical medicine, Medicine, Organ transplantation, Transplantation medicine, Immunosuppressants, Macrolides, Cardiac surgery, Tacrolimus, Transplant rejection, Immunosuppressive drug, Heart transplantation

NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.

Key Points: 
  • "The current approval expands the indications for PROGRAF from liver, kidney and heart transplants to adult and pediatric patients who receive a lung transplant in combination with other medicines to help prevent organ rejection."
  • The FDA granted Orphan Drug Designation (ODD) to PROGRAF for the prevention of rejection after lung transplant in September 2019.
  • PROGRAFis a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart or lung transplants, in combination with other immunosuppressants.
  • PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, heart or lung transplant.

Synaptogenix to Present Data at Alzheimer's Association International Conference 2021 Highlighting Bryostatin Restores Cognitive Function Above Baseline

Retrieved on: 
Wednesday, July 14, 2021
Branches of biology, Health sciences, Biology, Bryostatin, Macrolides, Total synthesis, Pharmacognosy, Neuroscience, Alzheimer's disease, Drug discovery, Neurodegeneration

The Company's lead drug candidate, Bryostatin-1, will be featured in a poster presentation entitled: "Bryostatin Restores Cognitive Functions Above Baseline in Advanced Alzheimer's Disease ("AD") Patients: A Regenerative Therapeutic Strategy."

Key Points: 
  • The Company's lead drug candidate, Bryostatin-1, will be featured in a poster presentation entitled: "Bryostatin Restores Cognitive Functions Above Baseline in Advanced Alzheimer's Disease ("AD") Patients: A Regenerative Therapeutic Strategy."
  • Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases.
  • Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease.
  • The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome.

TFF Pharmaceuticals Announces Completion of Enrollment and Preliminary Data from its Phase 1 Clinical Trial of Tacrolimus Inhalation Powder

Retrieved on: 
Tuesday, July 13, 2021
Branches of biology, Drugs, Biology, Orphan drugs, Astellas Pharma, Immunosuppressants, Macrolides, Tacrolimus, Magnesium in biology, Dose

In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects.

Key Points: 
  • In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects.
  • Peak blood levels were measured 15 min after dosing, and trough blood levels were measured 12 hours after dosing for each subject.
  • These data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are sufficient for efficacious immunosuppression.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder.

TFF Pharmaceuticals Hosting Key Opinion Leader Perspectives on Thin Film Freezing Applications

Retrieved on: 
Monday, June 7, 2021
Health care, Astellas Pharma, Immunosuppressants, Macrolides, Tacrolimus, Health, Pharmaceutical industry in China, Drugs

AUSTIN, Texas, June 07, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines.

Key Points: 
  • AUSTIN, Texas, June 07, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines.
  • TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder.
  • To learn more about TFF Pharmaceuticals and its product candidates, visit the Companys website at https://tffpharma.com.

Temsirolimus Injection Now Available from Fresenius Kabi

Retrieved on: 
Friday, May 21, 2021
Research, FDA, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Macrolides, Polyenes, Antineoplastic drugs, Temsirolimus, Sirolimus, Fresenius, Health care, Clinical medicine, Medicine, Temsirolimus Injection, Fresenius Kabi, TEMSIROLIMUS INJECTION, FRESENIUS KABI

b"Fresenius Kabi announced today the immediate availability of Temsirolimus Injection in the United States.

Key Points: 
  • b"Fresenius Kabi announced today the immediate availability of Temsirolimus Injection in the United States.
  • Fresenius Kabi\xe2\x80\x99s Temsirolimus Injection is supplied as a kit including one vial of 25 mg/mL Temsirolimus solution and one vial of diluent.\nThis press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20210521005009/en/\nTemsirolimus, for the treatment of renal cancer, is now available in the U.S. from Fresenius Kabi.
  • If alternatives cannot be used, dose modifications of Temsirolimus Injection are recommended.\nThis Important Safety Information does not include all the information needed to use Temsirolimus Injection safely and effectively.

TFF Pharmaceuticals to Hold First Quarter 2021 Financial and Business Results Conference Call on May 13, 2021

Retrieved on: 
Tuesday, May 4, 2021
Biotechnology, General Health, Health, Pharmaceutical, Clinical trials, Drugs, Dosage forms, Astellas Pharma, Immunosuppressants, Macrolides, Tacrolimus, Powder, Health care, Health sciences, TFF Pharmaceuticals’ Thin Film Freezing technology platform, TFF Pharmaceuticals, TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM, TFF PHARMACEUTICALS

The TFF process results in a \xe2\x80\x9cBrittle Matrix Particle,\xe2\x80\x9d which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue.

Key Points: 
  • The TFF process results in a \xe2\x80\x9cBrittle Matrix Particle,\xe2\x80\x9d which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder.
  • The TFF Platform is protected by 42 patents issued or pending in the US and internationally.
  • To learn more about TFF Pharmaceuticals and its product candidates, visit the Company\xe2\x80\x99s website at https://tffpharma.com.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210504005800/en/\n"

Oral Nanoparticle-Encapsulated Bryostatin-1 Found Effective for Treating Cognitive Deficits in an Alzheimer’s disease Mouse Model

Retrieved on: 
Tuesday, May 4, 2021
Engineering, Health, Manufacturing, General Health, Research, Science, Bryostatin, Macrolides, Total synthesis, LSU Health Sciences Center, Aphios Corporation:, LSU HEALTH SCIENCES CENTER, APHIOS CORPORATION:

AD transgenic mice were treated with a nanoparticle encapsulated Bryostatin-1 three times the week before testing and then daily for five days of testing.

Key Points: 
  • AD transgenic mice were treated with a nanoparticle encapsulated Bryostatin-1 three times the week before testing and then daily for five days of testing.
  • Across the acquisition phase, we observed that mice treated with nanoencapsulated Bryostatin-1 had shorter latencies, increased time in the target zone and decreased time in the opposite quadrant.
  • Mice were also given one day of retention testing after a 2-week period without drug.
  • The content of this release is solely the responsibility of the authors and does not represent the official views of NIA and NIH.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210504005455/en/\n"

Synaptogenix to Present at Sachs 4th Annual Neuroscience Innovation Forum

Retrieved on: 
Monday, April 26, 2021
Branches of biology, Natural sciences, Chemistry, Bryostatin, Macrolides, Total synthesis, Alzheimer's disease, Amyloidosis, Proteins, Amyloid beta, Tau protein, Preclinical development

Regenerative efficacy of bryostatin, and other Synaptogenix platform drugs, is complemented by other demonstrated efficacies to prevent neuronal death, reduce A Beta-oligomers, and reduce tau phosphorylation in pre-clinical AD models.

Key Points: 
  • Regenerative efficacy of bryostatin, and other Synaptogenix platform drugs, is complemented by other demonstrated efficacies to prevent neuronal death, reduce A Beta-oligomers, and reduce tau phosphorylation in pre-clinical AD models.
  • Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in AD.
  • The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome.
  • Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over.

Synaptogenix Announces Phase 2b Bryostatin-1 Clinical Trial Update

Retrieved on: 
Thursday, April 1, 2021
Branches of biology, Health sciences, Health, Clinical research, Bryostatin, Macrolides, Total synthesis, Alzheimer's disease, Neurodegeneration, Clinical trial, Placebo

NEW YORK, April 1, 2021 /PRNewswire/ -- Synaptogenix, Inc.(OTC: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced an update on its ongoing National Institute of Health ("NIH") sponsored Phase 2b clinical trial of Bryostatin-1 in patients suffering from moderately severe Alzheimer's disease ("AD").

Key Points: 
  • NEW YORK, April 1, 2021 /PRNewswire/ -- Synaptogenix, Inc.(OTC: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced an update on its ongoing National Institute of Health ("NIH") sponsored Phase 2b clinical trial of Bryostatin-1 in patients suffering from moderately severe Alzheimer's disease ("AD").
  • By having adequate safeguards against baseline imbalance and a more conventional six-month duration trial, we expect to avoid any issues with placebo effects.
  • Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease.
  • These forward-looking statements include statements regarding the Phase 2 clinical trial of Bryostatin-1 and further studies, and continued development of use of Bryostatin-1 for AD and other cognitive diseases.