PDUFA

Biopharma Veteran Ivor Macleod Joins SCYNEXIS as Chief Financial Officer

Retrieved on: 
Tuesday, October 25, 2022
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JERSEY CITY, N.J., Oct. 25, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that Ivor Macleod, an accomplished biopharma industry executive, has joined the Company as Chief Financial Officer.

Key Points: 
  • JERSEY CITY, N.J., Oct. 25, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that Ivor Macleod, an accomplished biopharma industry executive, has joined the Company as Chief Financial Officer.
  • We are thrilled to welcome Ivor to the SCYNEXIS management team, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS.
  • Ivor has over 30 years of experience in the life sciences industry and has held multiple financial and operational roles, including supporting research and development, product launch, and subsequent commercialization.
  • Mr. Macleod joined SCYNEXIS from Athersys, Inc. where he served as Chief Financial Officer since January of 2020.

SCYNEXIS Presents Positive Interim Data of Oral Ibrexafungerp for Severe Fungal Infections from Ongoing Phase 3 FURI Study During IDWeek 2022

Retrieved on: 
Monday, October 24, 2022
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All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.

Key Points: 
  • All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.
  • The analyses were presented during IDWeek 2022 held in Washington, D.C., October 19-23, 2022.
  • The data presented includes 113 patients enrolled in the FURI study who had completed treatment through October 2021.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review

Retrieved on: 
Wednesday, October 26, 2022
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Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI).
  • The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2023.
  • The FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application.
  • Seres has received an upfront license payment of $175 million and will receive an additional $125 million upon FDA approval of SER-109.

Hugel Aesthetics Receives FDA Acceptance of BLA Resubmission for LetibotulinumtoxinA for Injection for Glabellar Lines

Retrieved on: 
Tuesday, October 25, 2022
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Hugel America, Inc. (Hugel Aesthetics) announced today the acceptance of its Biologics License Application for letibotulinumtoxinA, by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Hugel America, Inc. (Hugel Aesthetics) announced today the acceptance of its Biologics License Application for letibotulinumtoxinA, by the U.S. Food and Drug Administration (FDA).
  • The FDA considered the resubmission a Class 2 response and has assigned a April 6, 2023 action date per the Prescription Drug User Fee Act (PDUFA).
  • Jim Hartman, President of Hugel Aesthetics, stated, We have worked diligently to advance our regulatory submission of letibotulinumtoxinA.
  • Hugel Aesthetics is a division of the global medical aesthetics leader, Hugel, Inc., focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, and Australia.

Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol® for the Treatment of Dry Eye Disease

Retrieved on: 
Monday, October 24, 2022
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The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review.

Key Points: 
  • The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review.
  • The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliqs NDA after reviewing the application is June 8, 2023.
  • If approved, CyclASol would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease.
  • Novaliq further plans to submit a marketing authorization application to the European Medicines Agency and further authorities in 2023.

Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Retrieved on: 
Monday, October 24, 2022
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The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

Key Points: 
  • The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.
  • The FDAs prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
  • Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

WCG FDAnews Announces: PDUFA and BsUFA Reauthorization Developments Webinar on Nov. 8, 2022

Retrieved on: 
Tuesday, October 25, 2022
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FALLS CHURCH, Va., Oct. 25, 2022 /PRNewswire-PRWeb/ -- PDUFA and BsUFA Reauthorization Developments What Regulatory, Compliance, and Quality Professionals Need to Know Tuesday, Nov. 8, 2022, 1:30 p.m.–3:00 p.m. EST https://wcg.swoogo.com/pdufa-and-bsufa

Key Points: 
  • Former FDA official will provide the clarity you need in preparation for the PDUFA, BsUFA reauthorization changes.
  • After challenging debates, Congress passed a bare-bones reauthorization of the prescription drug and biosimilars user fee programs.
  • What does the future hold for the accelerated approval and clinical trial diversity drug- and biologic-related riders?
  • Now is the time to prepare for the inevitable changes.

Silverback Therapeutics, Inc. announces the FDA’s acceptance of ARS Pharmaceuticals’ NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) including Anaphylaxis

Retrieved on: 
Friday, October 21, 2022
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If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

Key Points: 
  • If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.
  • The majority of adverse events in clinical trials were mild in nature without any meaningful nasal irritation or pain.
  • There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions.
  • ARS Pharma is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis.

ARS Pharmaceuticals Announces FDA Acceptance of NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) Including Anaphylaxis

Retrieved on: 
Friday, October 21, 2022
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If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

Key Points: 
  • If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023.
  • There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions.
  • ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis.

U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for CAMZYOS® (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy

Retrieved on: 
Friday, October 21, 2022
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Currently, it is recommended that many patients with severe symptomatic obstructive hypertrophic cardiomyopathy undergo SRT.

Key Points: 
  • Currently, it is recommended that many patients with severe symptomatic obstructive hypertrophic cardiomyopathy undergo SRT.
  • Key secondary endpoints include impact on exercise gradient LVOT, NYHA Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) and biomarkers at Week 16.
  • Patients are typically diagnosed in their 40s or 50s, and as many as 50% of patients have a hereditary predisposition.
  • The most frequent cause of obstructive HCM is mutations in the heart muscle proteins of the sarcomere.