Fast track

Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer

Retrieved on: 
Monday, February 22, 2021
Fast track, Health sciences, Health care, Drugs, Orphan drugs, Food and Drug Administration, Breakthrough therapy, Pelareorep

Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.
  • According to the FDA, a Fast Track Drug must show some advantage over available therapy, including:
    Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer.
  • Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design.
  • We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.

Immunocore’s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA

Retrieved on: 
Friday, February 19, 2021
Health sciences, Health, Clinical medicine, Immunocore, Breakthrough therapy, Uveal melanoma, Melanoma, Fast track, Nivolumab, Pembrolizumab

Bahija Jallal, Chief Executive Officer of Immunocore, said: We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020.

Key Points: 
  • Bahija Jallal, Chief Executive Officer of Immunocore, said: We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020.
  • Tebentafusp has also been granted Fast Track Designation and orphan drug designation from the FDA for uveal melanoma and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme.
  • If approved, Immunocore believes tebentafusp would be the first new therapy for the treatment of metastatic uveal melanoma in 40 years.
  • Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

PharmaDrug Files for FDA Orphan Drug Designation for DMT in Stroke

Retrieved on: 
Thursday, February 11, 2021
Food and Drug Administration, Pharmaceuticals policy, Health sciences, Health, Life sciences, Drug discovery, Pharmacy, Biotechnology law, Orphan drug, Breakthrough therapy, Orphan Drug Act, Fast track

As such, the development of novel approaches to treat ischemic stroke, such as PharmaDrug's DMT program, represent a critical development in reducing patients resulting neurological deficit.

Key Points: 
  • As such, the development of novel approaches to treat ischemic stroke, such as PharmaDrug's DMT program, represent a critical development in reducing patients resulting neurological deficit.
  • With the submission of our orphan drug application to the FDA now complete we will move swiftly to accelerate the research and development of DMT for acute ischemic stroke," said Daniel Cohen, CEO of PharmaDrug.
  • "Additionally, we will continue to broaden our DMT clinical programs by taking advantage of valuable FDA regulatory incentives such as orphan drug, fast track and breakthrough therapy designations."
  • The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

Ellodi Pharmaceuticals Announces Fast Track Designation Granted by the FDA to APT-1011 for the Treatment of Eosinophilic Esophagitis (EoE)

Retrieved on: 
Monday, February 8, 2021
FDA, Health, Clinical trials, Research, Pharmaceutical, Science, Health, Fast track, Food and Drug Administration, Eosinophilic esophagitis, EOE, Articles, Medical specialties, Ellodi Pharmaceuticals, Eosinophilic Esophagitis, APT-1011

We look forward to working closely with the FDA to optimize and expedite the development of APT-1011.

Key Points: 
  • We look forward to working closely with the FDA to optimize and expedite the development of APT-1011.
  • The Fast Track designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission and symptomatic improvement after 12 weeks of treatment (induction), and the long-term maintenance of these improvements.
  • Ellodi Pharmaceuticals is focused on the clinical development of APT-1011, a novel therapy in Phase 3 development for the treatment of Eosinophilic Esophagitis (EoE).
  • Food and Drug Administration Fast Track: Fast Track | FDA
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210208005483/en/

Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome

Retrieved on: 
Friday, February 5, 2021
Life sciences, Biotechnology law, Drug discovery, Orphan drug, Pharmaceuticals policy, Fast track, Articles, Health

Dr. Miller also reviewed the current treatment landscape and unmet need in PWS, as well as the positive biochemical, physical, and behavioral changes observed to date with DCCR treatment in her patients.

Key Points: 
  • Dr. Miller also reviewed the current treatment landscape and unmet need in PWS, as well as the positive biochemical, physical, and behavioral changes observed to date with DCCR treatment in her patients.
  • Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS.
  • Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in theU.S.and EU, and Fast Track Designation in theU.S.
  • Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.

Theratechnologies’ Lead Peptide Drug Conjugate TH1902 Receives FDA Fast Track Designation for the Treatment of Sortilin-expressing Cancers

Retrieved on: 
Thursday, February 4, 2021
Fast track, Food and Drug Administration, Life sciences, Health care, Biotechnology

Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902.

Key Points: 
  • Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902.
  • Theratechnologies announced on January 7, 2021 that it had received a Study May Proceed letter from the FDA for the Phase 1 clinical trial of TH1902.
  • The FDAs fast track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • The purpose of fast track designation is to bring important new drugs to patients earlier.

Cerecor Announces Fast Track Designation for CERC-803 for the Treatment of Leukocyte Adhesion Deficiency Type II

Retrieved on: 
Tuesday, February 2, 2021
Food and Drug Administration, Health sciences, Health care, Health, Fast track, Accelerated approval, Breakthrough therapy, Food and Drug Administration Safety and Innovation Act

We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II, said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor.

Key Points: 
  • We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II, said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor.
  • Fast Track Designation offers us broader access to the FDA and an expedited review process, giving us the potential for accelerated approval to bring a much-needed therapy for patients with LAD-II.
  • Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need.
  • Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.

Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA

Retrieved on: 
Friday, January 29, 2021
Food and Drug Administration, Fast track, Health care, Health, Priority review, Life sciences, Accelerated approval, Breakthrough therapy

BEIJING and BRIDGEWATER, N.J., Jan. 29, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai:603087.SH), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma.

Key Points: 
  • BEIJING and BRIDGEWATER, N.J., Jan. 29, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai:603087.SH), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma.
  • The FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • Receiving Fast Track Designation potentiates frequent meetings and written communication with the FDA.
  • The GLR2007 application is also eligible for Rolling Review and may be eligible for Accelerated Approval, and Priority Review[3].

Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA

Retrieved on: 
Friday, January 29, 2021
Food and Drug Administration, Fast track, Health care, Health, Priority review, Life sciences, Accelerated approval, Breakthrough therapy

BEIJING and BRIDGEWATER, N.J., Jan. 29, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai: 603087.SH), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma.

Key Points: 
  • BEIJING and BRIDGEWATER, N.J., Jan. 29, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai: 603087.SH), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma.
  • The FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • Receiving Fast Track Designation potentiates frequent meetings and written communication with the FDA.
  • The GLR2007 application is also eligible for Rolling Review and may be eligible for Accelerated Approval, and Priority Review[3].

LSQ Experiences Explosive Platform Growth in 2020

Retrieved on: 
Thursday, January 28, 2021
Supply chain management, Economy, Corporate finance, Working capital management, FastTrack, Finance, Supply chain finance, Fast track, LSQ, Working capital, Dynamic discounting, Money

ORLANDO, Fla., Jan. 28, 2021 /PRNewswire/ --LSQ, a leading provider of technology-driven working capital solutions, today highlighted its business progress and key achievements for 2020 anchored by the continued growth of its LSQ FastTrack Working Capital Platform.

Key Points: 
  • ORLANDO, Fla., Jan. 28, 2021 /PRNewswire/ --LSQ, a leading provider of technology-driven working capital solutions, today highlighted its business progress and key achievements for 2020 anchored by the continued growth of its LSQ FastTrack Working Capital Platform.
  • We also reached an important inflection point in the growth of our LSQ FastTrack platform, added exciting new strategic partnerships, and remained a resilient source of funding for our clients throughout the pandemic," stated Dan Ambrico, CEO of LSQ.
  • LSQ continued the accelerated growth of LSQ FastTrack, it's unified working capital platform that allows enterprises of all sizes to offer supply chain finance , dynamic discounting, and accounts receivable finance to their entire Seller ecosystem.
  • LSQ formed a technology partnership with LexisNexis to integrate supply chain finance for legal receivables into their CounselLink platform.