Fast track

Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

Retrieved on: 
Monday, July 13, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
  • The FDAs decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2, said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer.
  • We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward, said zlem Treci, Chief Medical Officer at BioNTech.
  • The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

Retrieved on: 
Monday, July 13, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
  • The FDAs decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2, said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer.
  • We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward, said zlem Treci, Chief Medical Officer at BioNTech.
  • The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H2158 for the Treatment of Chronic Hepatitis B Virus Infection

Retrieved on: 
Thursday, July 9, 2020

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need.

Key Points: 
  • The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need.
  • 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.
  • The Company previously received Fast Track designation for its first-generation core inhibitor ABI-H0731, currently in Phase 2 development.
  • Assembly Biosciences, Inc.is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome.

CorMedix Inc. Reports Submission of Defencath™ New Drug Application

Retrieved on: 
Wednesday, July 8, 2020

The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath.

Key Points: 
  • The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath.
  • The FDA has 60 days to review the submission for completeness to make a filing decision and grant a priority or standard review.
  • Khoso Baluch, CorMedix CEO commented,I would like to thank the team for their tremendous effort to get us to the submission of the NDA last week.
  • FDA granted rolling submission of the new drug application (NDA) and CorMedix has submitted the NDA.

EspeRare Receives FDA Breakthrough Therapy Designation for Investigational Prenatal Treatment ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Retrieved on: 
Monday, July 6, 2020

These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .

Key Points: 
  • These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .
  • The FDA Breakthrough Therapy Designation intends to expedite the development and review of drugs for serious or life-threatening conditions.
  • Having the FDA Breakthrough Therapy Designation means scientists can aspire starting a clinical trial to confirm the findings for ER-004 and ultimately, if successful, make this treatment an option for families.
  • In Europe, the program receives support from the EMA's PRIME (Priority Medicines) and also the Orphan Drug Designation.

EspeRare Receives FDA Breakthrough Therapy Designation for Investigational Prenatal Treatment ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Retrieved on: 
Monday, July 6, 2020

These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .

Key Points: 
  • These results, demonstrating that this prenatal treatment has a profound and life-changing effect on these infants,werepublished in the New England Journal of Medicine 1 .
  • The FDA Breakthrough Therapy Designation intends to expedite the development and review of drugs for serious or life-threatening conditions.
  • Having the FDA Breakthrough Therapy Designation means scientists can aspire starting a clinical trial to confirm the findings for ER-004 and ultimately, if successful, make this treatment an option for families.
  • In Europe, the program receives support from the EMA's PRIME (Priority Medicines) and also the Orphan Drug Designation.

Sun BioPharma, Inc. Receives FDA Fast Track Designation for SBP-101

Retrieved on: 
Tuesday, June 30, 2020

One of FDAs Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs.

Key Points: 
  • One of FDAs Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs.
  • Programs with Fast Track Designation may benefit from more frequent meetings with and written communications from FDA, in addition to being eligible for accelerated approval and priority review if certain criteria are met.
  • Fast Track Designation also provides eligibility for a rolling review of a New Drug Application (NDA), which allows for completed sections of an NDA to be submitted for FDA review.Usually NDA review does not begin until the company has submitted the entire application to the FDA.
  • Fast Track Designation is important for Sun BioPharma because it enhances our ability to develop SBP-101 as efficiently as possible, said Suzanne Gagnon, M.D., Chief Medical Officer of Sun BioPharma.

Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Retrieved on: 
Friday, June 26, 2020

This FDA Breakthrough Therapy designation is an important milestone in the development of AXS-05 for Alzheimers disease agitation, a serious, prevalent, and debilitating condition for which there is currently no approved therapy, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.

Key Points: 
  • This FDA Breakthrough Therapy designation is an important milestone in the development of AXS-05 for Alzheimers disease agitation, a serious, prevalent, and debilitating condition for which there is currently no approved therapy, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.
  • We look forward to working with the FDA over the coming months as we advance the development of AXS-05 for the treatment of Alzheimers disease agitation.
  • Breakthrough Therapy designation is granted by the FDA in order to expedite the development and review of drugs for serious or life-threatening conditions.
  • AXS-05 has been granted U.S. Food and Drug Administration Breakthrough Therapy designation for major depressive disorder, Fast Track designation for treatment resistant depression, and Breakthrough Therapy and Fast Track designations for Alzheimers disease agitation.

Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L

Retrieved on: 
Tuesday, June 23, 2020

"The Fast Track designation by the FDA provides further validation of seviprotimut-L as a potential new and important cancer vaccine for patients with localized melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Operating Officer at CK Life Sciences.

Key Points: 
  • "The Fast Track designation by the FDA provides further validation of seviprotimut-L as a potential new and important cancer vaccine for patients with localized melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Operating Officer at CK Life Sciences.
  • Benefits of Fast Track designation include more frequent communication with the FDA, a rolling submission of the marketing application, and eligibility for Priority Review and Accelerated Approval, if relevant criteria are met.
  • The interval between progression from Stage II to Stage III/IV melanoma marks a critical therapeutic intervention point to improve survival.
  • Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines.

Ovid Therapeutics Receives FDA Rare Pediatric Disease Designation for OV101 for the Treatment of Angelman Syndrome

Retrieved on: 
Friday, June 19, 2020

The FDA has previously granted Orphan Drug and Fast Track designations for OV101 for the treatment of Angelman syndrome.

Key Points: 
  • The FDA has previously granted Orphan Drug and Fast Track designations for OV101 for the treatment of Angelman syndrome.
  • OV101 has received Rare Pediatric Disease Designation from the FDA for the treatment of Angelman syndrome.
  • The FDA has also granted Orphan Drug and Fast Track designations for OV101 for both the treatment of Angelman syndrome and Fragile X syndrome.
  • In addition, the European Commission (EC) has granted orphan drug designation to OV101 for the treatment of Angelman syndrome.