Fast track

4D Molecular Therapeutics Receives FDA Fast Track Designation for 4D-310 Gene Therapy for Treatment of Fabry Disease

Thursday, August 13, 2020 - 12:00pm

4D-310 is a gene medicine engineered with a proprietary optimized AAV capsid discovered by 4DMT through its proprietary Therapeutic Vector Evolution platform.

Key Points: 
  • 4D-310 is a gene medicine engineered with a proprietary optimized AAV capsid discovered by 4DMT through its proprietary Therapeutic Vector Evolution platform.
  • Were pleased that the FDA has granted Fast Track designation for 4D-310, said David Kirn, MD, co-founder, chairman and chief executive officer of 4DMT.
  • Patients with Fabry currently have significant unmet medical needs, despite enzyme replacement therapies [ERT].
  • Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.

Insurtech Leader FastTrack Unveils New Logo and Refreshed Website

Thursday, August 6, 2020 - 1:38pm

Furthermore, FastTrack's website reboot provides new and returning visitors alike with a fresh perspective of FastTrack's tailor-made automation technology and how it drives its comprehensive suite of Solutions & Services in a visually engaging and user-friendly format.

Key Points: 
  • Furthermore, FastTrack's website reboot provides new and returning visitors alike with a fresh perspective of FastTrack's tailor-made automation technology and how it drives its comprehensive suite of Solutions & Services in a visually engaging and user-friendly format.
  • "We are beyond thrilled to share our new look logo and website with our clients and industry partners," states Paul Taylor, COO of FastTrack.
  • FastTrack is the leading full-service technology platform in the Life & Disability insurance vertical that automates critical elements of the claims adjudication and new business application process, helping Carriers enhance the accuracy of claim and underwriting decisions.
  • Our primary goal is to help claims professionals and underwriters make consistent, repeatable, clear, objective, and defensible benefit and employability determinations.

Biosight Granted U.S. FDA Fast Track Designation for BST-236 for the Treatment of Acute Myeloid Leukemia

Tuesday, August 4, 2020 - 1:00pm

BST-236, Biosights lead product candidate, is a novel antimetabolite, designed to provide the benefit of intensive chemotherapy while avoiding much of its toxicity.

Key Points: 
  • BST-236, Biosights lead product candidate, is a novel antimetabolite, designed to provide the benefit of intensive chemotherapy while avoiding much of its toxicity.
  • The FDA Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions to fulfill an unmet medical need, ultimately enabling drugs to reach patients more rapidly.
  • A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters related to the drugs clinical development plan as well as eligibility for accelerated approval and priority review.
  • BST-236 was granted Orphan Drug Designation from the FDA, which entitles Biosight to seven years of market exclusivity upon BST-236 marketing approval for the treatment of AML.

ReViral Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection

Tuesday, August 4, 2020 - 1:00pm

ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection.

Key Points: 
  • ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection.
  • We are very pleased that sisunatovir has received Fast Track designation for the treatment of serious RSV, a significant global health concern, said Alex Sapir, CEO, ReViral.
  • A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review, and potential approval.
  • ReViral is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics, with an initial focus on the treatment of respiratory syncytial virus (RSV).

FDA Grants Fast Track Designation for BCX9930 in PNH

Monday, August 3, 2020 - 12:00pm

RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
  • PNH patients have a tremendous need for therapy improvements and it is exciting for patients that the FDA has reviewed our proof of concept PNH data and granted Fast Track status.
  • We look forward to working closely with the FDA to fully utilize the opportunities presented by our Fast Track designation to advance this important medicine to patients as quickly as possible in PNH.
  • This press release contains forward-looking statements, including statements regarding potential benefits associated with an FDA Fast Track designation.

DGAP-News: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 1:00am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • "The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte.
  • "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

Imara Announces IMR-687 Granted Fast Track Designation and Rare Pediatric Disease Designation for Treatment of Beta-Thalassemia

Thursday, July 30, 2020 - 12:00pm

The FDA previously granted Orphan Drug designation for IMR-687 for the treatment of patients with beta-thalassemia and Orphan Drug, Fast Track and Rare Pediatric Disease designations for the treatment of patients with sickle cell disease.

Key Points: 
  • The FDA previously granted Orphan Drug designation for IMR-687 for the treatment of patients with beta-thalassemia and Orphan Drug, Fast Track and Rare Pediatric Disease designations for the treatment of patients with sickle cell disease.
  • We are pleased to receive from the FDA both Fast Track designation and Rare Pediatric Disease designation for IMR-687.
  • Fast Track designation helps us create the opportunity to potentially accelerate the development of IMR-687 in beta-thalassemia.
  • Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process.

Larimar Therapeutics Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CTI-1601 for the Treatment of Friedreich’s Ataxia

Tuesday, July 28, 2020 - 1:00pm

The U.S. Food and Drug Administration (FDA) previously granted Orphan Drug, Fast Track and Rare Pediatric Disease designations to CTI-1601 for the treatment of FA.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) previously granted Orphan Drug, Fast Track and Rare Pediatric Disease designations to CTI-1601 for the treatment of FA.
  • Larimar expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) this year.
  • Phase 1 trial of CTI-1601, which has the potential to become the first frataxin replacement therapy for patients with FA.
  • Orphan drug designation in the EU is granted by the European Commission based on a positive opinion issued by the EMA COMP.

Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation

Tuesday, July 28, 2020 - 12:45pm

More information about FDA Fast Track designation can be found at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approva... .

Key Points: 
  • More information about FDA Fast Track designation can be found at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approva... .
  • These mutations include extracellular domain allosteric mutations of HER2, as well as EGFR and HER2 kinase domain exon 20 insertions, and additional activating oncogenic drivers of ErbB.
  • Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

CytRx Corporation Highlights Orphazyme's Completion of Rolling Submission of its New Drug Application with the U.S. FDA for Arimoclomol in Niemann-Pick Disease Type-C

Tuesday, July 21, 2020 - 2:00pm

Arimoclomol has received Fast Track and Breakthrough Therapy Designations for the treatment of NPC, in addition to Orphan Drug and Rare Pediatric Disease Designations.

Key Points: 
  • Arimoclomol has received Fast Track and Breakthrough Therapy Designations for the treatment of NPC, in addition to Orphan Drug and Rare Pediatric Disease Designations.
  • The FDA has up to 60 days to determine whether to accept the application for review.
  • These data support the role of enhanced Heat-Shock Protein 70 expression in Niemann-Pick disease Type C and may have applications in other lysosomal disorders."
  • In addition, one of CytRx's drug candidates, arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties.