Fast track

BerGenBio Receives FDA Fast Track Designation For Bemcentinib / Anti-PD-(L)1 Combination In NSCLC

Retrieved on: 
Tuesday, June 8, 2021
Branches of biology, Life sciences, Biology, Biotechnology, Fast track, Food and Drug Administration, Biomarker, AXL receptor tyrosine kinase

Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

Key Points: 
  • Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.
  • It will enable BerGenBio to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market faster.
  • BerGenBio has developed proprietary biomarkers and companion diagnostic assays for selection of AXL positive patients, the cAXL assay is validated for clinical trial use.
  • Richard Godfrey, Chief Executive Officer of BerGenBio, commented:"Building on our encouraging clinical and translational data, we are excited to receive Fast Track designation from the FDA for the promising combination of bemcentinib in combination with a checkpoint inhibitor.

FDA Grants Accelerated Approval for Alzheimer's Drug

Retrieved on: 
Monday, June 7, 2021
Health sciences, Health, Life sciences, Food and Drug Administration, Medical statistics, Clinical trials, Pharmaceutical industry, Medical terminology, Accelerated approval, Surrogate endpoint, Fast track, Breakthrough therapy

Aduhelm was approved using the accelerated approval pathway , which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Key Points: 
  • Aduhelm was approved using the accelerated approval pathway , which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
  • Accelerated approval can be based on the drug's effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.
  • As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation."
  • If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

Protagonist Therapeutics Receives FDA Breakthrough Therapy Designation for Rusfertide in Polycythemia Vera

Retrieved on: 
Thursday, June 3, 2021
Health sciences, Life sciences, Health, Drug discovery, Breakthrough therapy, Pharmacy, Food and Drug Administration, Fast track, Therapy, Food and Drug Administration Safety and Innovation Act

Breakthrough Therapy Designation requires that the drug candidate treat a serious or life-threatening disease or condition.

Key Points: 
  • Breakthrough Therapy Designation requires that the drug candidate treat a serious or life-threatening disease or condition.
  • "We are thrilled to receive the Breakthrough Therapy Designation for rusfertide in PV, a serious disease where the need for different and better treatment options is clear and pressing," said Suneel Gupta, PhD, Chief Development Officer at Protagonist.
  • Breakthrough Therapy Designation offers additional advantages over Fast Track Designation, including FDA actions to expedite both planned clinical trials and plans for expediting the manufacturing development strategy.
  • Breakthrough Therapy Designation is an FDA program intended to expedite the development and regulatory review of investigational therapies that are designed to address serious or life-threatening conditions.

FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa

Retrieved on: 
Thursday, June 3, 2021
Food and Drug Administration, Priority review, Health care, Health, Prescription Drug User Fee Act, Fast track

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the Oleogel-S10 NDA of November 30, 2021.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the Oleogel-S10 NDA of November 30, 2021.
  • Oleogel-S10previously received Fast Track Designationand Rare Pediatric Disease Designation from the FDA.
  • If the NDA for Oleogel-S10 is approved, the Company will apply for a priority review voucher.
  • Such forward-looking statements reflect the Companys current beliefs and assumptions and are based on information currently available to management.

Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH

Retrieved on: 
Wednesday, June 2, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Peptide hormones, Hormones, Boehringer Ingelheim, Fast track, Glucagon, Endocrine system, Boehringer, Organ systems

20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH).

Key Points: 
  • 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH).
  • The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need.
  • Together with our partner Zealand Pharma, we look forward to working closely with the FDA as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.
  • Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH, said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma.

BridgeBio Pharma Receives FDA Fast Track Designation for Encaleret for the Treatment of Autosomal Dominant Hypocalcemia Type 1

Retrieved on: 
Tuesday, June 1, 2021
Calcium, Rare diseases, Medicine, Electrolyte disturbances, Medical specialties, Clinical medicine, Hypoparathyroidism, Hypocalcemia, Fast track, Hypercalciuria

BridgeBio announced the Fast Track designation on World Hypoparathyroidism Awareness Day, an annual global awareness and education event designed to spotlight and support people living with ADH1 and other types of hypoparathyroidism.

Key Points: 
  • BridgeBio announced the Fast Track designation on World Hypoparathyroidism Awareness Day, an annual global awareness and education event designed to spotlight and support people living with ADH1 and other types of hypoparathyroidism.
  • Hypocalcemia can cause severe muscle cramping and seizures, while hypercalciuria can lead to impaired kidney function and kidney stone formation.
  • It is encouraging to receive Fast Track designation from the FDA as it recognizes the seriousness of ADH1 and the potential for encaleret to address this profound unmet medical need.
  • If the development program is successful, encaleret could be the first approved therapy indicated specifically for the treatment of ADH1.

TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with UKONIQ® (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Retrieved on: 
Tuesday, May 25, 2021
Medicine, Clinical medicine, Orphan drugs, Drugs, Chronic lymphocytic leukemia, Tyrosine kinase inhibitors, Antineoplastic drugs, Leukemia, CLL, Fast track, Progression-free survival, Genta

The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
  • FDA previously granted Fast Track designation to the combination of ublituximab and UKONIQ for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.
  • The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm.
  • Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia.

Imago BioSciences to Present Updated Data from Phase 2 Studies of Bomedemstat for the Treatment of Essential Thrombocythemia and Myelofibrosis at 2021 European Hematology Association Virtual Congress

Retrieved on: 
Friday, May 21, 2021
Health, General Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Health, Life sciences, Drug discovery, Primary myelofibrosis, Thrombocythemia, Orphan drug, Essential thrombocythemia, Fast track

Imago is focused on improving the quality of life of patients with cancer and bone marrow diseases in addition to prolonging their lives.

Key Points: 
  • Imago is focused on improving the quality of life of patients with cancer and bone marrow diseases in addition to prolonging their lives.
  • Imago is evaluating Bomedemstat as a potentially disease-modifying therapy in two Phase 2 clinical trials for the treatment essential thrombocythemia (ET) and myelofibrosis (MF).
  • Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, Orphan Drug Designation for treatment of AML, and PRIME designation by the European Medicines Agency for the treatment of MF.
  • To learn more, visit www.imagobio.com , www.myelofibrosisclinicalstudy.com , www.etclinicalstudy.com and follow us on Twitter @ImagoBioRx , Facebook , LinkedIn and YouTube .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210521005395/en/\n'

Larimar Therapeutics Receives European Medicines Agency Priority Medicines (PRIME) Designation for CTI-1601 in Friedreich’s Ataxia

Retrieved on: 
Thursday, May 20, 2021
Life sciences, Health, Pharmaceuticals policy, Food and Drug Administration, Biotechnology law, Drug discovery, Orphan drug, Fast track, XC2, European Medicines Agency

For more information on the PRIME program visit the EMA website .\nIn addition to PRIME designation, CTI-1601 has also been granted Rare Pediatric Disease designation, Fast Track designation and Orphan Drug designation by the\xc2\xa0U.S.

Key Points: 
  • For more information on the PRIME program visit the EMA website .\nIn addition to PRIME designation, CTI-1601 has also been granted Rare Pediatric Disease designation, Fast Track designation and Orphan Drug designation by the\xc2\xa0U.S.
  • Currently in Phase 1 clinical trials in the\xc2\xa0U.S., CTI-1601 has been granted Rare Pediatric Disease designation, Fast Track designation and Orphan Drug designation by the\xc2\xa0U.S.
  • Food and Drug Administration\xc2\xa0(FDA), Orphan Drug Designation by the\xc2\xa0European Commission, and PRIME designation by the European Medicines Agency.\nLarimar Therapeutics, Inc. (Nasdaq: LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases.
  • Larimar undertakes no obligation to update any forward-looking statements for any reason, except as required by law.\n'

AffyImmune Therapeutics' AIC100 Granted Fast Track Designation for Treating Thyroid Cancer

Retrieved on: 
Monday, May 17, 2021
Anatomy, Food and Drug Administration, Life sciences, Branches of biology, Fast track, Anaplastic thyroid cancer, Thyroid, Pembrolizumab

b'NATICK, Mass., May 17, 2021 /PRNewswire/ -- AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, announced today that the US Food and Drug Administration (FDA) granted Fast Track designation to its lead compound, AIC100, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

Key Points: 
  • b'NATICK, Mass., May 17, 2021 /PRNewswire/ -- AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, announced today that the US Food and Drug Administration (FDA) granted Fast Track designation to its lead compound, AIC100, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.
  • The company previously received Orphan Drug designation for AIC100.\nThe FDA\'s Fast Track designation is designed to facilitate development and expedite review of drug candidates to treat serious conditions and address an unmet medical need.
  • Receipt of Fast Track designation provides grounds for more frequent interaction with the FDA throughout the drug development process for more rapid advancement, earlier approval and access for patients.\n"We are pleased to have received Fast Track designation for our first-in-human CAR T cell product currently being tested in patients with refractory thyroid cancer," remarked Eric von Hofe, President and COO of AffyImmune.
  • "It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need.