Fast track

Soligenix Receives Conditional FDA Acceptance of Proposed Brand Name HyBryte™ for SGX301 in CTCL

Retrieved on: 
Wednesday, April 7, 2021
Health sciences, Life sciences, Health, Orphan drugs, Food and Drug Administration, Pharmaceuticals policy, Breakthrough therapy, Biotechnology law, Cutaneous T cell lymphoma, Fast track

Final approval of the HyBryte brand name is conditioned on FDA approval of the product candidate, SGX301.

Key Points: 
  • Final approval of the HyBryte brand name is conditioned on FDA approval of the product candidate, SGX301.
  • "We are pleased that the FDA has conditionally accepted the name HyBryte for SGX301," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
  • CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.
  • HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

Innovation Pharma Completes Interim Safety Data Review—DMC Approves Increased Dosing Frequency in Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients

Retrieved on: 
Monday, April 5, 2021
Chemical compounds, Food and Drug Administration, Antibiotics, Brilacidin, Guanidines, Pyrimidines, Pyrrolidines, Health, Life sciences, Fast track

Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC.

Key Points: 
  • Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC.
  • Efficacy data was not reviewed by the DMC and remains blinded.
  • Trial data for Veklury could serve as a benchmark in evaluating Brilacidin outcomes.
  • Innovation Pharma is developing Brilacidin, a defensin-mimetic, under Fast Track designation from the U.S. Food and Drug Administration (FDA).

Passage Bio Receives European Commission Orphan Designation for PBKR03 for Treatment of Krabbe Disease

Retrieved on: 
Monday, April 5, 2021
Health, Life sciences, Lipid storage disorders, Rare diseases, Pharmaceuticals policy, Food and Drug Administration, Drug discovery, Orphan drug, Krabbe disease, Krabbe, Fast track, European Medicines Agency

The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products.

Key Points: 
  • The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products.
  • The U.S. Food and Drug Administration (FDA) previously granted Fast Track, Orphan Drug and Rare Pediatric Disease designations to PBKR03 for the treatment of Krabbe disease.
  • PBKR03 has the potential to treat both the central nervous system and peripheral nerve manifestations observed in Krabbe disease patients.
  • Passage Bio expects to initiate a global Phase1/2 clinical trial, GALax-C, for PBKR03 in the first half of 2021.

Moleculin Receives FDA Approval of Fast Track Designation for Annamycin in the Treatment of Sarcoma Lung Metastases

Retrieved on: 
Tuesday, March 30, 2021
Fast track, Food and Drug Administration, Life sciences, Drugs, Antineoplastic drugs, Orphan drugs, Biotechnology, Breakthrough therapy

"We are pleased to receive our second Fast Track Designation from the FDA for Annamycin.

Key Points: 
  • "We are pleased to receive our second Fast Track Designation from the FDA for Annamycin.
  • We now have potential pathways for accelerated approval in two indications, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia," commented Walter Klemp, Moleculin's Chairman and CEO.
  • "Not only does this make us eligible for accelerated approval and priority review for our NDA submission, but it serves as an important reminder of the unmet need in STS lung metastases.
  • We are now focused on initiating our internally funded clinical trial in the US, possibly prior to mid-year.

TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with UKONIQ™(umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia

Retrieved on: 
Monday, March 29, 2021
Food and Drug Administration, Fast track, Life sciences, CLL, Chronic lymphocytic leukemia, FDA Special Protocol Assessment, Leukemia, Clinical medicine, Medicine, Genta, P110δ

The trial met its primary endpoint and results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2020.

Key Points: 
  • The trial met its primary endpoint and results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2020.
  • The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
  • Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia.
  • A drug that receivesFast Trackdesignation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologics License Application or New Drug Application.

The Philippines FDA Approves the Use of Leronlimab to Treat a COVID-19 Patient

Retrieved on: 
Monday, March 29, 2021
Leronlimab, Drugs, Food and Drug Administration, Fast track, Health care, Life sciences, CCR5 receptor antagonist

The Company is shipping leronlimab to its partner, Chiral Pharma Corporation, its importer in the Philippines.

Key Points: 
  • The Company is shipping leronlimab to its partner, Chiral Pharma Corporation, its importer in the Philippines.
  • I want to thank several teams of people who have worked relentlessly to advance our drug to CSP approval in the Philippines.
  • Our expanded CytoDyn team is also working with several other countries to provide COVID-19 patients access to leronlimab.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.

REN001 Granted Fast Track Designation by FDA for Patients with Primary Mitochondrial Myopathies

Retrieved on: 
Wednesday, March 24, 2021
Fast track, Food and Drug Administration, Life sciences, Biotechnology, Health care

SAN DIEGO, March 24, 2021 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the United States Food and Drug Administration (FDA) granted Fast Track designation to REN001 for the treatment of patients with primary mitochondrial myopathies (PMM).

Key Points: 
  • SAN DIEGO, March 24, 2021 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the United States Food and Drug Administration (FDA) granted Fast Track designation to REN001 for the treatment of patients with primary mitochondrial myopathies (PMM).
  • Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.
  • The FDAs decision to grant Fast Track designation to REN001 signifies an important milestone in our development program, said Gregory J. Flesher, President and Chief Executive Officer of Reneo.
  • There are currently no medications approved to treat patients with PMM, and this designation underscores the importance of developing treatment options for patients who suffer from this debilitating disease.

UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, March 18, 2021
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, Health sciences, Health, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Cancer treatments, Aziridines, Mitomycin C, Fast track, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.

Sagimet Biosciences Receives Fast Track Designation from U.S. Food and Drug Administration for FASN Inhibitor TVB-2640 in NASH

Retrieved on: 
Tuesday, March 16, 2021
Branches of biology, FASN, Lipotoxicity, Fast track, Biomarker, Biology, Life sciences

In a recent Phase 2 randomized placebo-controlled trial (FASCINATE-1), TVB-2640 demonstrated statistically significant improvement across steatosis, inflammation/lipotoxicity, fibrosis and metabolic biomarkers important in NASH.

Key Points: 
  • In a recent Phase 2 randomized placebo-controlled trial (FASCINATE-1), TVB-2640 demonstrated statistically significant improvement across steatosis, inflammation/lipotoxicity, fibrosis and metabolic biomarkers important in NASH.
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    George Kemble, Ph.D., Sagimet's chief executive officer,said, "The FDA's Fast Track designation for TVB-2640 demonstrates recognition of TVB-2640's potential to address unmet needs of NASH patients.
  • Fast Track designation is designed to facilitate drug development and expedite the review of drugs that are developed to treat serious conditions and fill an unmet medical need.
  • The company has unique expertise in FASN biology and has created a pipeline of proprietary FASN inhibitors.

LSQ Completes a Type 1 SOC 1 Examination for its LSQ FastTrack Working Capital Platform

Retrieved on: 
Monday, March 15, 2021
File sharing networks, FastTrack, Fast track, LSQ

ORLANDO, Fla., March 15, 2021 /PRNewswire/ -- LSQ, a leading provider of technology-driven working capital solutions, announced the successful completion of their 2020 System and Organizational Controls (SOC) 1 Type 1 examination for their LSQ FastTrack working capital platform.

Key Points: 
  • ORLANDO, Fla., March 15, 2021 /PRNewswire/ -- LSQ, a leading provider of technology-driven working capital solutions, announced the successful completion of their 2020 System and Organizational Controls (SOC) 1 Type 1 examination for their LSQ FastTrack working capital platform.
  • Successful completion of the Type 1 SOC 1 examination demonstrates our efforts to build a secure platform," said Steve Piubeni, director of compliance at LSQ.
  • LSQ FastTrack is an intuitive working capital platform built to meet the needs of buyers and their suppliers.
  • LSQ FastTrack enables companies to get paid faster, optimize working capital, assess their customers' health, and provide insights into their business's performance from any device.