New Drug Application

Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Health, Medical Devices, Diabetes, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Research, Control, Overweight, Vivani, Symantec Endpoint Protection, Obesity, Visual perception, Medicine, Amylin Pharmaceuticals, Acceleration, Chemistry, New Drug Application, Patient, Conditional sentence, Weight loss, Stroke, Mouse, Acquisition, Second Sight, Insurance, Trial of the century, Alkermes, Risk, Investment, Injection, Depreciation, Food, Pharmaceutical industry

Research and development expenses: Research and development expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022.

Key Points: 
  • Research and development expenses: Research and development expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022.
  • General and administrative expenses: General and administrative expenses during the fourth quarter of 2023 were $1.5 million, compared to $3.4 million during the fourth quarter of 2022.
  • Other income (expense): Other income (expense), net during the fourth quarter of 2023 was $0.2 million, compared to $0.5 million during the fourth quarter of 2022.
  • Net Loss: The net loss during the fourth quarter of 2023 was $6.0 million, compared to $7.3 million during the fourth quarter of 2022.

Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial

Retrieved on: 
Monday, March 25, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, New Drug Application, Patient, Venetoclax, NDA, Standard of care, Acute myeloid leukemia, Clinical trial, Azacitidine, Bone marrow, Food, RARA, Pharmaceutical industry

This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.

Key Points: 
  • This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis.
  • Syros expects to report these pivotal data by the middle of the fourth quarter of 2024.
  • “We are pleased to announce the completion of enrollment of the 190 patients necessary to support the primary CR endpoint in SELECT-MDS-1.
  • Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical trial in newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression.

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

Retrieved on: 
Tuesday, March 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, AP, Mutation, BP, Disease, New Drug Application, Patient, ALL, Shanda, CML, MD, University, MD Anderson Cancer Center, Priority review, MRD, CP, TKI, Glomus tumor, Food, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
  • This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Verastem Oncology Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Strategic management, Diagnosis, Initiation, Research and development, Conference, Immunotherapy, Part, FAK, New Drug Application, Patient, Cancer, RAMP, Accelerated approval (FDA), NDA, Table, SGO, BRAF, Society, IND, Abstract, Bank statement, AACR, Pancreatic cancer, Investment, Verastem Oncology, MEK, Therapy, Safety, GAAP, Gynecologic Oncology (journal), Food, FDA, Annual general meeting, Pharmaceutical industry

Verastem Oncology ended the fourth quarter of 2023 with cash, cash equivalents and investments of $137.1 million.

Key Points: 
  • Verastem Oncology ended the fourth quarter of 2023 with cash, cash equivalents and investments of $137.1 million.
  • Research & development expenses for the 2023 Quarter were $22.5 million, compared to $10.7 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $8.6 million, compared to $6.1 million for the 2022 Quarter.
  • These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP.

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Research, Biopsy, Conference, Carcinoma, Chemistry, Webcast, New Drug Application, Medac, Patient, Mitomycins, NDA, CMC, Software, Safety, Nephrectomy, Patent, Medicare, Investment, RTW, ATLAS, Ureteroscopy, Gesellschaft mit beschränkter Haftung, Food, Pharmaceutical industry

The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.

Key Points: 
  • The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.
  • The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA.
  • The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025.
  • Generated annual net product revenue of $82.7 million in 2023, compared with $64.4 million in 2022 in representing ~28% annual growth.

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

Retrieved on: 
Wednesday, March 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Brain, NSCLC, New Drug Application, Patient, JAMA Oncology, NDA, Anaplastic lymphoma kinase, Crizotinib, Safety, File, Holding, Food, ALK, PDUFA, Pharmaceutical industry

Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Key Points: 
  • Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
  • The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC.
  • The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
  • In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile.

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, Neoplasm, NDA, Cancer, Breakthrough therapy, Senior, HCM, HKEX, Dor, IRC, Prognosis, PFS, Ophthalmology, Pharmaceutical industry

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

WIT Legal Releases New Report on 2023 Activities and Trends in Hatch-Waxman Litigation

Retrieved on: 
Wednesday, March 20, 2024
Orange Book, New Drug Application, Orange, Patent, Abbreviated New Drug Application, WIT, NDA, Johnson & Johnson, Generic drug

NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.

Key Points: 
  • NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.
  • The new WIT report examines Abbreviated New Drug Application (ANDA) cases and the Orange Book-listed products at issue.
  • "Our intent is to provide the most comprehensive review of true ANDA litigation available," said Michael Connelly, WIT President.
  • Additionally, the report goes beyond the specific companies involved to provide insight into the corporate families driving ANDA litigation to highlight potential market dynamics and litigation trends.

FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA® (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children

Retrieved on: 
Monday, March 11, 2024
Astellas Pharma, Capsule, New Drug Application, Patient, IM, Research, Infection, Azole, Marketing, FDA, Food, Pharmaceutical industry

NORTHBROOK, Ill., March 11, 2024 /PRNewswire/ -- Astellas Pharma US, Inc.  (TSE: 4503, President: Mark Reisenauer, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.  

Key Points: 
  • On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.
  • The FDA grants orphan drug exclusivity to orphan drugs that receive FDA marketing approval.
  • The FDA previously granted orphan drug exclusivity for CRESEMBA in 2015 for the treatment of IA and IM in adults.
  • "Astellas recognizes the importance of addressing significant unmet medical needs, especially for pediatric patients with rare and potentially life-threatening IA and IM infections.

Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Lexicon, CRL, New Drug Application, FDA, CKD, Diabetes, Patient, Hearing, NDA, Pharmaceutical industry

THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.

Key Points: 
  • THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD).
  • The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.
  • “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer.
  • Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.