Fast track

Denali Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to ETV:IDS (DNL310) for the Treatment of Patients with Hunter Syndrome (MPS II)

Retrieved on: 
Thursday, March 11, 2021
Food and Drug Administration, Orphan drugs, Health care, Fast track, Health, Breakthrough therapy, Monoclonal antibodies

Using Denalis Transport Vehicle technology, we have designed DNL310 to treat both body and brain in Hunter syndrome after intravenous administration.

Key Points: 
  • Using Denalis Transport Vehicle technology, we have designed DNL310 to treat both body and brain in Hunter syndrome after intravenous administration.
  • Receiving Fast Track designation is an important milestone in the DNL310 development program, and we look forward to our continued collaboration with the FDA to bring safe and effective treatments to patients with Hunter syndrome.
  • Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • Denali expects that Fast Track designation may allow for early and frequent communication with the FDA regarding the development of DNL310 for the treatment of Hunter syndrome.

AltruBio’s Neihulizumab Granted Fast Track Designation by the FDA for Steroid Refractory Acute Graft Versus Host Disease

Retrieved on: 
Monday, March 8, 2021
Medical specialties, Clinical medicine, Transplantation medicine, Medicine, Graft-versus-host disease, Fast track, Stem cells, Biotechnology

Dr. Judy Chou, president & CEO of AltruBio stated, Receiving Fast Track designation for neihulizumab in steroid refractory acute GVHD is another important regulatory milestone for this clinical program.

Key Points: 
  • Dr. Judy Chou, president & CEO of AltruBio stated, Receiving Fast Track designation for neihulizumab in steroid refractory acute GVHD is another important regulatory milestone for this clinical program.
  • This designation validates the fact that although there are treatment options for this condition, significant unmet medical need remains.
  • In order to be considered for Fast Track in an indication with approved therapies, a Fast Track drug must show the potential for advantage over available therapy.
  • In addition to the company sponsored SR-aGVHD trial, it is currently being studied for front line acute graft versus host disease (aGVHD) in an investigator sponsored trial.

Caladrius Biosciences Announces Orphan Drug Designation for CLBS12 for the Treatment of Buerger’s Disease

Retrieved on: 
Monday, March 8, 2021
Health, Pharmaceuticals policy, Life sciences, Food and Drug Administration, Biotechnology law, Drug discovery, Orphan drug, Fast track, Orphan Drug Act

We are very pleased that the FDA has granted orphan drug designation to CLBS12 in Buergers disease.

Key Points: 
  • We are very pleased that the FDA has granted orphan drug designation to CLBS12 in Buergers disease.
  • Achieving orphan designation for CLBS12 takes us one step closer to realizing our goal of fulfilling the unmet medical need for Buergers Disease patients around the world.
  • Orphan Drug designation confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to a receipt by the FDA of marketing approval.
  • Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease.

U.S. Food and Drug Administration Grants Fast Track Designation to Three Passage Bio Gene Therapy Candidates Targeting Rare CNS Disorders

Retrieved on: 
Monday, March 8, 2021
Food and Drug Administration, Life sciences, Health, Fast track, Articles, Pharmaceuticals policy, GM1, Dementia, Orphan drug

Fast Track designation facilitates the expedited development and review of a new drug that demonstrates potential to address unmet medical needs and treats a serious or life-threatening disease.

Key Points: 
  • Fast Track designation facilitates the expedited development and review of a new drug that demonstrates potential to address unmet medical needs and treats a serious or life-threatening disease.
  • In the last year, we have laid the groundwork for Passage Bio to boldly execute on our strategy, said Dr. Goldsmith.
  • PBGM01 is being studied for the treatment of GM1, a rare and often life-threatening CNS disorder that impacts patients worldwide.
  • In addition to Fast Track designation, the FDA has granted PBFT02 Orphan Drug designation for the treatment of frontotemporal dementia.

On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for pafolacianine sodium injection for Identification of Ovarian Cancer During Surgery

Retrieved on: 
Wednesday, March 3, 2021
Health, Life sciences, Oncology, Gynaecological cancer, Gynaecology, Ovarian cancer, Fast track, Cancer, Orphan drug

This designation shortens the review period from the standard 10 months to six months from the acceptance of the NDA.

Key Points: 
  • This designation shortens the review period from the standard 10 months to six months from the acceptance of the NDA.
  • Pafolacianine sodium injection was investigated for use in ovarian cancer under Special Protocol Agreement and received both Fast Track and Orphan designations from the FDA.
  • Additionally, pafolacianine sodium injection is being investigated in lung cancer under Fast Track designation.
  • Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Oblato Announces Fast Track Designation of OKN-007 for Diffuse Intrinsic Pontine Glioma from the FDA

Retrieved on: 
Wednesday, March 3, 2021
Diffuse intrinsic pontine glioma, Fast track, Glioma, Food and Drug Administration, Fast track, Health, Life sciences, Medicine, Zotiraciclib, Clinica 0-19

PRINCETON, N.J., March 3, 2021 /PRNewswire/ --Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG).

Key Points: 
  • PRINCETON, N.J., March 3, 2021 /PRNewswire/ --Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG).
  • 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.
  • In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG.
  • "We anticipate that the Fast Track Designation for DIPG will shorten the NDA review process.

Insurtech Leader FastTrack Bolsters Business Development Team to Meet Market Demand

Retrieved on: 
Tuesday, March 2, 2021
American television series, Television series, FastTrack, Fast track, Chuck

Chuck brings his unmatched claims experience to a talented FastTrack team already deep with Life & Disability vertical proficiencies.

Key Points: 
  • Chuck brings his unmatched claims experience to a talented FastTrack team already deep with Life & Disability vertical proficiencies.
  • "Over the course of my career, I have been able to build an amazing network that is very important to me," states Chuck.
  • "As Director of Business Development for FastTrack, I will continue to strive to be a trusted industry partner that people can depend on to deliver high-value claim handling and risk management automation technology solutions tailor-made for their specific needs."
  • Thomas Capato, CEO of FastTrack, states, "We are incredibly excited to have Chuck as an integral piece on our growing Business Development team.

Retrotope Granted Rare Pediatric Disease Designation from FDA for Lead Development Candidate, RT001, in Two Life-Threatening Neurodegenerative Indications

Retrieved on: 
Thursday, February 25, 2021
Rare diseases, Branches of biology, Clinical medicine, Health, Retrotope, Priority review, Di-deuterated linoleic acid ethyl ester, Food and Drug Administration, Infantile neuroaxonal dystrophy, Friedreich's ataxia, Fast track, Ifood

The first rare pediatric disease designation is for the treatment of infantile neuroaxonal dystrophy (INAD), with the second covering the treatment of Friedreichs ataxia (FA).

Key Points: 
  • The first rare pediatric disease designation is for the treatment of infantile neuroaxonal dystrophy (INAD), with the second covering the treatment of Friedreichs ataxia (FA).
  • To qualify for rare pediatric disease designation, these diseases must affect fewer than 200,000 people in the United States.
  • Retrotope is eligible to receive a priority review voucher should the company secure approval for RT001 in either one of these indications.
  • Recipients of Fast Track designation are eligible for greater access to the FDA during the clinical development process and may also qualify for priority review.

Kura Oncology Receives FDA Breakthrough Therapy Designation for Tipifarnib in Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Wednesday, February 24, 2021
Drugs, Orphan drugs, Health sciences, Health care, Chloroarenes, Imidazoles, Tipifarnib, Breakthrough therapy, Head and neck cancer, Fast track

Tipifarnibs Breakthrough Therapy Designation is based on data from RUN-HN, a Phase 2 clinical trial evaluating tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC.

Key Points: 
  • Tipifarnibs Breakthrough Therapy Designation is based on data from RUN-HN, a Phase 2 clinical trial evaluating tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC.
  • We are very pleased that the FDA has awarded Breakthrough Therapy Designation to tipifarnib, and we appreciate the agencys affirmation of its potential to treat this devastating disease, said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.
  • The granting of FDAs Breakthrough Therapy Designation is based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies.
  • In addition to Breakthrough Therapy Designation, tipifarnib has been granted Fast Track designation by the FDA for the treatment of patients with HRAS mutant HNSCC.

Adial to File Fast Track Application for AD04 with the FDA

Retrieved on: 
Tuesday, February 23, 2021
Fast track, Food and Drug Administration, Life sciences, Healthcare in the United States, Health

Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adials position that AD04 should be considered eligible for an FDA expedited review program.

Key Points: 
  • Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adials position that AD04 should be considered eligible for an FDA expedited review program.
  • Adials correspondence and consultation with the FDA following its expedited review filing in September 2020, leads us to believe that AD04 qualifies for Fast Track consideration, said Adials Head of Regulatory, Dr. Jack Reich.
  • We are working with our regulatory counsel to prepare our Fast Track submission after consultation with the FDA, commented Adials CEO, William Stilley.
  • When reviewing a Fast Track application where there are available therapies, the Fast Track drug must demonstrate advantages over the available therapy currently approved for the indication in order to be considered as meeting an unmet medical need.