Fast track

 UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, August 4, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Chemical compounds, Health sciences, Organic compounds, Orphan drugs, Breakthrough therapy, Aziridines, Cancer treatments, Mitomycin C, Oncology, Fast track, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., 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.
  • 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.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005328/en/

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma

Retrieved on: 
Monday, August 2, 2021
Clinical medicine, Medicine, Medical specialties, Cancer immunotherapy, Cancer, Melanoma, Immunotherapy, ALKS, Alkermes, Fast track, Interleukin 2

DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.

Key Points: 
  • DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.
  • Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma.
  • The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.
  • "Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin's potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma

Retrieved on: 
Monday, August 2, 2021
Clinical medicine, Medicine, Medical specialties, Cancer immunotherapy, Cancer, Melanoma, Immunotherapy, ALKS, Alkermes, Fast track, Interleukin 2

DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.

Key Points: 
  • DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.
  • Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma.
  • The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.
  • "Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin's potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Bionomics Announces Plans to Conduct U.S. Initial Public Offering

Retrieved on: 
Monday, August 2, 2021
Finance, Financial markets, Financial economics, ADSS, American depositary receipt, OTC Markets Group, Public offering, Initial public offering

ADELAIDE, Australia, Aug. 2, 2021 /PRNewswire/ -- Bionomics Limited (ASX: BNO, OTCQB: BNOEF), (Bionomics) a global, clinical stage biopharmaceutical company, is pleased to announce that it plans to conduct a registered initial public offering of American Depositary Shares (ADSs) in the United States and a concurrent listing of ADSs on Nasdaq.

Key Points: 
  • ADELAIDE, Australia, Aug. 2, 2021 /PRNewswire/ -- Bionomics Limited (ASX: BNO, OTCQB: BNOEF), (Bionomics) a global, clinical stage biopharmaceutical company, is pleased to announce that it plans to conduct a registered initial public offering of American Depositary Shares (ADSs) in the United States and a concurrent listing of ADSs on Nasdaq.
  • The number of ADSs and price of the proposed offering have not yet been determined.
  • Each ADS would represent a certain number of fully paid ordinary shares in Bionomics.
  • All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our plans to conduct a registered initial public offering in the United States and the timing of the proposed offering.

ERYTECH Granted U.S. FDA Fast Track Designation for Eryaspase in Hypersensitive ALL

Retrieved on: 
Thursday, July 29, 2021
Life sciences, Health sciences, Health, Fast track, Food and Drug Administration, Orphan drug

We believe that the FDAs Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.

Key Points: 
  • We believe that the FDAs Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.
  • In April 2020, eryaspase was also granted Fast Track designation for the development of a second-line treatment of patients with metastatic pancreatic cancer.
  • The FDA and the European Medicines Agency have granted eryaspase orphan drug status for the treatment of pancreatic cancer and ALL.
  • ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.

Arrowhead Pharmaceuticals Receives Breakthrough Therapy Designation from U.S. FDA for ARO-AAT for the Treatment of Alpha-1 Antitrypsin Deficiency Associated Liver Disease

Retrieved on: 
Thursday, July 29, 2021
Infectious diseases, Automotive, General Automotive, FDA, Clinical trials, Cardiology, Biotechnology, Pharmaceutical, Health, Oncology, Health sciences, Life sciences, Health, Hepatology, Pharmacy, Food and Drug Administration, Pharmaceuticals policy, Breakthrough therapy, Alpha-1 antitrypsin deficiency, Fast track, Orphan drug, Alpha-1 Antitrypsin-Associated Liver Disease, Arrowhead Pharmaceuticals, ALPHA-1 ANTITRYPSIN-ASSOCIATED LIVER DISEASE, ARROWHEAD PHARMACEUTICALS

Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission.

Key Points: 
  • Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission.
  • Javier San Martin, M.D., chief medical officer at Arrowhead, said: Patients with AATD associated liver disease currently have no available treatment options other than a liver transplant.
  • Being granted Breakthrough Therapy designation from the FDA is an important milestone for the investigational ARO-AAT program.
  • Individuals with the homozygous PiZZ genotype have severe deficiency of functional AAT leading to pulmonary disease and liver disease.

Endologix LLC Receives FDA Breakthrough Device Designation for ChEVAS™ System

Retrieved on: 
Monday, July 19, 2021
Health, FDA, Medical devices, Surgery, Clinical trials, Cardiology, Biotechnology, Health sciences, Food and Drug Administration, Health, Pharmaceutical industry, Investigational device exemption, Clinical trial, Priority review, Breakthrough therapy, Fast track

Endologix LLC , a leader in the treatment of vascular disease, today announced the companys ChEVAS (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Endologix LLC , a leader in the treatment of vascular disease, today announced the companys ChEVAS (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
  • Breakthrough Devices receive priority review by FDA, and the program provides opportunities for early interaction with FDA personnel to expedite the review and approval process.
  • ChEVAS is currently being evaluated through the ChEVAS ONE IDE (Investigational Device Exemption) clinical study that is approved to enroll approximately 120 patients at up to 50 clinical sites worldwide.
  • Endologix LLC is a California-based, global medical device company dedicated to improving patients lives by providing innovative therapies for the interventional treatment of vascular disease.

Lysogene Announces FDA Fast Track Designation for LYS-GM101 Gene Therapy for the Treatment of GM1 Gangliosidosis

Retrieved on: 
Thursday, July 8, 2021
Stem cells, Biotechnology, Pharmaceutical, Health, FDA, Genetics, Clinical trials, Other Health, Lipid storage disorders, Rare diseases, Branches of biology, Life sciences, Biology, Glycolipids, Gangliosidosis, GM1 gangliosidoses, GLB1, Ganglioside, GM1, Fast track

GM1 gangliosidosis is a fatal autosomal recessive disease caused by mutations in the GLB1 gene leading to accumulation of GM1 ganglioside in neurons resulting in progressive neurodegeneration.

Key Points: 
  • GM1 gangliosidosis is a fatal autosomal recessive disease caused by mutations in the GLB1 gene leading to accumulation of GM1 ganglioside in neurons resulting in progressive neurodegeneration.
  • A product that receives Fast Track designation is eligible for more frequent interactions with FDA, potential eligibility for accelerated approval, priority review, and rolling Biologics License Application (BLA) review.
  • This Fast Track designation demonstrates the regulators sustained interest in Lysogenes cutting edge gene therapy program.
  • Lysogene is a gene therapy Company focused on the treatment of orphan diseases of the central nervous system (CNS).

Cend Therapeutics’ CEND-1 Granted Fast Track Designation for Pancreatic Cancer

Retrieved on: 
Tuesday, June 29, 2021
Food and Drug Administration, Clinical medicine, Medicine, Orphan drugs, Drugs, Antineoplastic drugs, Peptides, iRGD, Accelerated approval, Pancreatic cancer, Fast track, Priority review

CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.

Key Points: 
  • CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.
  • By awarding Fast Track Designation, the FDA has recognized CEND-1s potential to meaningfully improve outcomes for pancreatic cancer patients,said Andrew Dorr, MD, Chief Medical Officer of Cend.
  • Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.
  • Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patients immune system and immunotherapies to more effectively fight cancer.

Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency

Retrieved on: 
Monday, June 28, 2021
Drugs, Orphan drugs, Fast track, Food and Drug Administration, Life sciences, Recombinant factor VIIa, Priority review, Health care, Breakthrough therapy, Drotrecogin alfa

A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.

Key Points: 
  • A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.
  • Receiving a second Fast Track designation is another important milestone in our MarzAA development program.
  • FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
  • Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, an SQ administered next-generation engineered rFVIIa for the episodic treatment of bleeding in subjects with rare bleeding disorders.