Fast track

Adial Pharmaceuticals Provides Regulatory and Development Update

Retrieved on: 
Thursday, June 24, 2021
Life sciences, Biotechnology, Health sciences, Pharmaceutical industry, Food and Drug Administration, Pharmacy, Fast track, Biopharmaceutical, Medication

Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration.

Key Points: 
  • Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration.
  • Based on this feedback, Adial will review the additional requirements and data requested by the FDA for a Fast Track Designation.
  • The FDAs Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier.
  • Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions.

LSQ FastTrack® Expands Capabilities To Improve Access To Working Capital For More Businesses

Retrieved on: 
Wednesday, June 23, 2021
File sharing networks, FastTrack, Fast track

The unified platform allows for a single interface for businesses to fill their unique working capital needs.

Key Points: 
  • The unified platform allows for a single interface for businesses to fill their unique working capital needs.
  • FastTrack affords users the ability to securely upload invoices from any device to access working capital and gain real-time insights into their customers' credit.
  • "For many companies, access to working capital is their biggest barrier to growth and we want FastTrack to be at the center of making that access easier."
  • To help companies better understand the working capital options available through FastTrack, LSQ has launched a new web experience with expanded resources and functionality.

Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for PEDMARK™

Retrieved on: 
Tuesday, June 22, 2021
Chemistry, Physical sciences, Inorganic chemistry, Food and Drug Administration, United States Public Health Service, Ototoxicity, Cisplatin, Fast track

We are pleased that the FDA has accepted our PEDMARKresubmission, said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. We look forward to working closely with the FDA through the review process.

Key Points: 
  • We are pleased that the FDA has accepted our PEDMARKresubmission, said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. We look forward to working closely with the FDA through the review process.
  • If approved, PEDMARK stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.
  • Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients.
  • Obtaining Fast Track Designation and Breakthrough Therapy Designation by the FDA is no guarantee that the FDA will approve the NDA resubmission of PEDMARK.

Targovax receives Fast Track designation for ONCOS-102 in melanoma

Retrieved on: 
Tuesday, June 22, 2021
Cancer, Clinical medicine, Medicine, Food and Drug Administration, Immune system, Clusters of differentiation, Fast track, Mesothelioma, Programmed cell death protein 1, Melanoma, Nivolumab

The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.

Key Points: 
  • The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
  • Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
  • This Fast Track approval comes in addition to ONCOS-102s existing Fast Track designation in malignant pleural mesothelioma.
  • Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said"Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need.

Targovax receives Fast Track designation for ONCOS-102 in melanoma

Retrieved on: 
Tuesday, June 22, 2021
Cancer, Clinical medicine, Medicine, Food and Drug Administration, Immune system, Clusters of differentiation, Fast track, Mesothelioma, Programmed cell death protein 1, Melanoma, Nivolumab

The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.

Key Points: 
  • The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
  • Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
  • This Fast Track approval comes in addition to ONCOS-102s existing Fast Track designation in malignant pleural mesothelioma.
  • Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said"Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need.

Applied Therapeutics Granted Fast Track Designation by FDA for AT-007 for Galactosemia

Retrieved on: 
Thursday, June 17, 2021
Life sciences, Food and Drug Administration, Health, Fast track, Galactosemia, Orphan drug, Accelerated approval, PMM2 deficiency, Priority review

Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.

Key Points: 
  • Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.
  • Applied Therapeutics plans to submit an NDA for Accelerated Approval of AT-007 for the treatment of Galactosemia in the third quarter of this year.
  • FDA has previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT-007 for Galactosemia.
  • AT-007 has received both Orphan Drug and Pediatric Rare Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of Galactosemia and PMM2-CDG, and Fast Track designation for Galactosemia.

Cerevel Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to CVL-871 for the Treatment of Dementia-Related Apathy

Retrieved on: 
Tuesday, June 15, 2021
Food and Drug Administration, Health, Drug Safety, Fast track, Investigational New Drug, Priority review, New Drug Application, Dementia, Breakthrough therapy

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.

Key Points: 
  • 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.
  • The designation allows for early and more frequent communication and meetings with the FDA regarding the development of CVL-871 for the treatment of dementia-related apathy.
  • A candidate that receives Fast Track designation is also eligible for rolling review, and potentially priority review, of the marketing application.
  • Cerevel submitted an Investigational New Drug application, or IND, to the FDA for CVL-871 in the first quarter of 2021 for the treatment of dementia-related apathy.

Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma

Retrieved on: 
Monday, June 14, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Cancer treatments, Drugs, Clinical medicine, Cancer, Melanoma, Fast track, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Pembrolizumab, Glembatumumab vedotin, PVSRIPO, Istari Oncology, PVSRIPO, ISTARI ONCOLOGY

In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.

Key Points: 
  • In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
  • Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 30% of metastatic melanoma patients surviving 5 years1.
  • Fast Track is an FDA program designed to facilitate the expedited development of drugs to treat serious conditions and address an unmet medical need.
  • We are thrilled with FDAs decision to grant both Fast Track and Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma, said Matt Stober, President and Chief Executive Officer at Istari Oncology.

Ibex Granted FDA Breakthrough Device Designation

Retrieved on: 
Wednesday, June 9, 2021
Food and Drug Administration, United States Public Health Service, Fast track, Life sciences, United States Department of Health and Human Services, Health care, Breakthrough therapy

TEL AVIV, Israel, June 9, 2021 /PRNewswire/ -- Ibex Medical Analytics , the pioneer in AI-powered cancer diagnostics, today announced the granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of its platform.

Key Points: 
  • TEL AVIV, Israel, June 9, 2021 /PRNewswire/ -- Ibex Medical Analytics , the pioneer in AI-powered cancer diagnostics, today announced the granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of its platform.
  • The FDA's Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer.
  • This FDA designation is an important step forward in making this technology broadly available in the United States."
  • "We are honored to have been granted the Breakthrough Device Designation.

VBI Vaccines Granted FDA Fast Track Designation for VBI-1901 for the Treatment of Recurrent GBM

Retrieved on: 
Tuesday, June 8, 2021
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Research, Infectious diseases, Science, Clinical trials, Health, Brain tumor, Cancer, Glioblastoma, Oncology, Fast track, Causes of death, Life sciences, Fast Track Designation, VBI-1901 and GBM, VBI Vaccines Inc., FAST TRACK DESIGNATION, VBI-1901 AND GBM, VBI VACCINES INC.

VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, VBIs cancer vaccine immunotherapeutic candidate for the treatment of recurrent glioblastoma (GBM) patients with first tumor recurrence.

Key Points: 
  • VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, VBIs cancer vaccine immunotherapeutic candidate for the treatment of recurrent glioblastoma (GBM) patients with first tumor recurrence.
  • Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need.
  • Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM.
  • VBI Vaccines Inc. (VBI) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.