Fast Track

Caliway Received U.S. FDA Fast Track Designation for CBL-514 for the Treatment of Dercum's Disease

Retrieved on: 
Thursday, February 15, 2024
Fast Track, Collection, Physician, FDA, Food, Pain, Connective tissue, Growth, U.S. FDA, Dercum's disease, Lipolysis, Apoptosis, Microsoft Access, Patient, Clinical trial, Disease, EAP, Trial of the century, Pharmaceutical industry

NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum's disease treatment.

Key Points: 
  • - CBL-514 is the first drug to receive Fast Track designation for Dercum's disease treatment.
  • NEW TAIPEI CITY, Feb. 14, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment.
  • "We are very pleased to see the FDA's decision on granting Fast Track designation to CBL-514," said Vivian Ling, CEO of Caliway.
  • The Expanded Access Program is a program recognized by the FDA as a follow-on to their Fast Track Designation.

Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (Duchenne)

Retrieved on: 
Tuesday, February 13, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, Becker muscular dystrophy, Fast Track, Therapy, LYNX, FOX, Food, ODD, Survival, Ageing, Pharmaceutical industry

Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne.

Key Points: 
  • Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne.
  • EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy (Becker).
  • The FDA previously granted EDG-5506 Orphan Drug Designation (ODD) for the treatment of Duchenne and Becker, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designation for the treatment of Becker.
  • “Every day is important for individuals living with Duchenne and their families, and we are pleased that the FDA granted Fast Track designation,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise.

Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open

Retrieved on: 
Friday, February 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, RNA, Ministry, Fast Track, Food, Conference, Ensitrelvir, Drug development, JAMA Network Open, Opportunism, Cough, Senior, Head, Fungal infection, Patient, Risk, Generic, Pharmaceutical industry

The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • “We’re pleased to present the data from our Phase 3 study conducted in Asia in this peer-reviewed article.
  • These results demonstrate accelerated resolution in a range of symptoms, reinforcing the potential of ensitrelvir across multiple patient profiles.
  • Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies.

Eplontersen granted U.S. FDA Fast Track designation for patients with transthyretin-mediated amyloid cardiomyopathy

Retrieved on: 
Thursday, February 8, 2024
Ionis Pharmaceuticals, RNA, Cardiovascular disease, Therapy, Fast Track, Patient, FDA, Orphan, Amyloidosis, IONS, AstraZeneca, Food, Ionis, ATTR, Polyneuropathy, DSM-IV codes, Pharmaceutical industry

CARLSBAD, Calif., Feb. 8, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults.

Key Points: 
  • CARLSBAD, Calif., Feb. 8, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults.
  • The FDA grants development programs Fast Track designation to facilitate the development and expedite the review of drugs that demonstrate the potential to treat serious conditions and fill an unmet medical need.
  • "CARDIO-TTRansform is the largest, most comprehensive study ever conducted in ATTR-CM patients, with results expected as early as next year."
  • WAINUA was granted Orphan Drug Designation in the U.S. and in the EU for the treatment of transthyretin-mediated amyloidosis (ATTR).

Arvinas and Pfizer’s Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer

Retrieved on: 
Tuesday, February 6, 2024
Fulvestrant, HER2, Breast cancer, Chimera, Fast Track, Patient, FDA, Food, Proteolysis, Disease, PFE, ARVN, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment of adults with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas and Pfizer.

Key Points: 
  • Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas and Pfizer.
  • As described by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • “The receipt of Fast Track designation reinforces the potential of vepdegestrant to provide an important new therapeutic option for people with ER+/HER2- breast cancer whose disease has progressed,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
  • “We are proud to continue our legacy of developing innovative treatment options for people impacted by metastatic breast cancer and look forward to working with the FDA as we advance our development program for vepdegestrant.”

Aqua-Tots Swim School Splashes into Toms River, New Jersey

Retrieved on: 
Monday, February 5, 2024
Parent, Curriculum, Life, Fast Track, Safety, School, Social media, Interest, Toy

Toms River, N.J., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim Schools , the largest international swim school franchise, is excited to announce that its third location in New Jersey, and 148th location worldwide, is now open.

Key Points: 
  • Toms River, N.J., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim Schools , the largest international swim school franchise, is excited to announce that its third location in New Jersey, and 148th location worldwide, is now open.
  • Aqua-Tots strives to help families create a legacy of safety by offering safe, affordable and accessible swim lessons.
  • To show their commitment to water safety, the Aqua-Tots Toms River location will be opening the school by providing the community unlimited free swim lessons from February 5-11.
  • To learn more about swim lessons at Aqua-Tots Toms River or to enroll, please visit aqua-tots.com/toms-river , call 732-917-4743 or email [email protected] .

BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305

Retrieved on: 
Wednesday, January 31, 2024
Epithelium, Ovarian cancer, Survival, Cancer, BNTX, Fast Track, Peritonitis, Patient, Ovary, Fast track (FDA), FDA, BioNTech, Food, ADC, Fallopian tube cancer, Vaccine, Hope, Glomus tumor

BNT325/DB-1305 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the trophoblast cell-surface antigen 2 (“TROP2”), a protein which is overexpressed on a range of tumor types.

Key Points: 
  • BNT325/DB-1305 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the trophoblast cell-surface antigen 2 (“TROP2”), a protein which is overexpressed on a range of tumor types.
  • The candidate is currently being evaluated in an ongoing Phase 1/2 study ( NCT05438329 ) in patients with TROP2-expressing advanced solid tumors.
  • Platinum-based chemotherapy is the backbone of treatment for ovarian epithelial cancer and related subtypes that form in the epithelial tissue.
  • “Recent studies have indicated the role of TROP2 in aggressive tumor growth and progression in patients with chemotherapy-resistant ovarian tumors.

Cellectar Biosciences Announces Enrollment of the First Patient in Pediatric High-Grade Gliomas Phase 1b Clinical Study

Retrieved on: 
Tuesday, January 30, 2024
Traffic barrier, Survival, NCI, Fast Track, Patient, Safety, Central nervous system, Glomus tumor, MOA, CNS, Bone marrow, Hope, SBIR, Ependymoma, Cancer, Pharmaceutical industry

“Treatment of pediatric patients with relapsed and refractory high-grade glioma and ependymoma is extremely challenging.

Key Points: 
  • “Treatment of pediatric patients with relapsed and refractory high-grade glioma and ependymoma is extremely challenging.
  • There are limited treatment options and high unmet clinical need for patients suffering from this aggressive cancer,” said Dr. Sameer Farouk Sait, pediatric hematologist-oncologist and assistant attending at Memorial Sloan Kettering Cancer Center.
  • “We understand the profound impact pediatric high-grade gliomas have on the lives of young patients and their families,” commented James Caruso, president and CEO of Cellectar.
  • We are hopeful its novel MOA will provide a meaningful treatment option for these young patients.”

Chemomab Therapeutics Announces New Publication Reinforcing the Clinical Potential of Its CCL24-Neutralizing Antibody CM-101 in Primary Sclerosing Cholangitis

Retrieved on: 
Tuesday, January 30, 2024
CCL24, Pathology, Role, Neutrophil, Patient, European, Therapy, Primary sclerosing cholangitis, Fibrosis, CMMB, Proteomics, In vitro, Potential, Orphan drug, CCL11, PSC, Myofibroblast, Health, TEL, Cell, Disease, CCL26, Fast Track, FDA, Protein, Doctor of Philosophy, Inflammation, Monocyte, Pharmaceutical industry

TEL AVIV, Israel, Jan. 30, 2024 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced publication of proteomic analyses that further demonstrate the unique role of the soluble protein CCL24 in driving pathologies associated with the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new studies reinforce the extensive existing evidence showing that Chemomab's first-in-class CCL24-neutralizing antibody CM-101 can interrupt these destructive processes. The study, "The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data"1 has been published in the current online version of the peer-reviewed journal Cells.

Key Points: 
  • The new studies reinforce the extensive existing evidence showing that Chemomab's first-in-class CCL24-neutralizing antibody CM-101 can interrupt these destructive processes.
  • The study, " The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data "1 has been published in the current online version of the peer-reviewed journal Cells.
  • CM-101 is a first-in-class CCL24-neutralizing monoclonal antibody whose dual anti-inflammatory and anti-fibrotic activity has demonstrated disease modifying potential in nonclinical studies of PSC and other fibro-inflammatory disorders.
  • CM-101 has Orphan Drug designation for PSC in the U.S. and the European Union and was recently awarded Fast Track designation by the FDA for the treatment of PSC in adults.

Ascidian Therapeutics Announces First-Ever IND for an RNA Exon Editor as FDA Approves Trial Plan and Fast Tracks ACDN-01 in Stargardt Disease and Other ABCA4 Retinopathies

Retrieved on: 
Monday, January 29, 2024
Retina, Patient, Therapy, DNA, Biotechnology, RNA, RNA editing, University, Stargardt disease, ABCA4, IND, Food, Interim, Safety, Fast Track, FDA, Bascom Palmer Eye Institute, Research, Pharmaceutical industry

BOSTON, Jan. 29, 2024 /PRNewswire/ -- Ascidian Therapeutics, a biotechnology company aspiring to treat human diseases by rewriting RNA, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track      designation for ACDN-01. ACDN-01 is the first-ever clinical-stage RNA exon editor and the only clinical-stage therapeutic targeting the genetic cause of Stargardt disease. Ascidian expects to initiate enrollment in the Phase 1/2 STELLAR study of ACDN-01 in Stargardt disease and other ABCA4 retinopathies in the first half of 2024.

Key Points: 
  • ACDN-01 is the first-ever clinical-stage RNA exon editor and the only clinical-stage therapeutic targeting the genetic cause of Stargardt disease.
  • Ascidian expects to initiate enrollment in the Phase 1/2 STELLAR study of ACDN-01 in Stargardt disease and other ABCA4 retinopathies in the first half of 2024.
  • Ascidian also announced that the FDA has granted Fast Track designation for ACDN-01.
  • This designation enables Ascidian to expedite development of ACDN-01 with regular feedback from FDA through the clinical-development process.