NDA

Lumicell Introduces Further Research and Insights in Fluorescence-Guided Surgery at the Society of Surgical Oncology (SSO) Annual Meeting

Retrieved on: 
Monday, March 25, 2024
Health, Surgery, Oncology, Medical Devices, Breast cancer, Feasibility, Detection, DVS, Massachusetts General Hospital, Light, Inc., Patient, Neoplasm, Stanford University Medical Center, NDA, University, Doctor of Philosophy, Society, Surgeon, Patient satisfaction, Surgical oncology, SSO, Hospital, PMA, Multimedia, MD Anderson Cancer Center, FDA, Associate professor, Medical imaging

View the full release here: https://www.businesswire.com/news/home/20240325761901/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240325761901/en/
    Barbara Smith, M.D, PhD., presented results from the INSITE study during the Breast Cancer Hub Zone talk during the SSO Annual Meeting 2024.
  • “It’s so energizing to see such a diversity of surgeons across different specialties come together to advance the collective field of surgical oncology,” said Jorge Ferrer, M.D., PhD, Chief Scientific Officer, Lumicell.
  • Most recently, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of the benefit-risk profile of LUMISIGHT™ (pegulicianine) during its March 5, 2024 meeting .
  • The FDA is expected to make a decision on Lumicell’s NDA and PMA in the near future.

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.

LENZ Therapeutics Announces Completion of Merger with Graphite Bio and Provides Update on Recent Clinical and Corporate Progress

Retrieved on: 
Thursday, March 21, 2024
Health, Research, Pharmaceutical, Science, Optical, Biotechnology, FDA, NDA, Therapy, Presbyopia, Pharmaceutical industry

The new combined company will operate under the name LENZ Therapeutics, Inc. and will commence trading on Nasdaq under the ticker symbol “LENZ” on March 22, 2024.

Key Points: 
  • The new combined company will operate under the name LENZ Therapeutics, Inc. and will commence trading on Nasdaq under the ticker symbol “LENZ” on March 22, 2024.
  • After 10 hours, 37% and 48% of patients treated with LNZ100 and LNZ101, respectively, maintained three-lines or greater improvement compared to vehicle.
  • Following the completion of the INSIGHT trial, LENZ initiated three pivotal Phase 3 CLARITY trials for LNZ100 and LNZ101.
  • Leerink Partners acted as exclusive financial advisor to Graphite Bio for the transaction and Goodwin Procter LLP served as its legal counsel.

Results from Italfarmaco Pivotal Phase 3 EPIDYS Study of Givinostat in Duchenne Muscular Dystrophy (DMD) Published in The Lancet Neurology

Retrieved on: 
Tuesday, March 19, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Hospitals, Genetics, Clinical Trials, VL, Civil service commission, Givinostat, Neurology, Catholic higher education, Diarrhea, MAA, The Lancet, Magnetic resonance imaging, Safety, Abdominal pain, NDA, Manuscript, Rehabilitation, Lancet Neurology, University, OLE, EMA, Degenerative disease, Doctor of Philosophy, MD, European Medicines Agency, Duchenne muscular dystrophy, European Commission, NSAA, FDA, DMD, Pediatrics, PDUFA, Pharmaceutical industry

Italfarmaco S.p.A. announced today that the full results from the Company’s pivotal phase 3 EPIDYS clinical trial with givinostat in ambulant boys 6 years of age and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.

Key Points: 
  • Italfarmaco S.p.A. announced today that the full results from the Company’s pivotal phase 3 EPIDYS clinical trial with givinostat in ambulant boys 6 years of age and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.
  • The full manuscript, titled, “Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomized, double-blind, placebo-controlled, phase 3 trial,” is published on The Lancet Neurology website .
  • Participants attended study site visits every 12 weeks for 72 weeks and were evaluated for all endpoints within the study protocol.
  • Upon completion of the 18-month double-blind period, EPIDYS study participants were eligible to enroll in an open-label extension study (OLE study) to receive givinostat on an ongoing basis.

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.

Venatorx Pharmaceuticals Expands Senior Leadership Team

Retrieved on: 
Tuesday, March 12, 2024
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Financial management, Quality control, Medication, Virginia University, Information technology, Goldman Sachs, CFO, Business, Shire (pharmaceutical company), State university system, Patient, Accounting, Strategic planning, NDA, CMC, IPO, Senior, HBV, MBA, Ernst & Young, Mylan, Chemistry, Investment, Therapy, Lehigh University, West Virginia University, CPA, Management

"These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success."

Key Points: 
  • "These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success."
  • He joined Venatorx from Aimmune/Nestle Health Science where he was a Senior Vice President and Head of Technical Operations.
  • Before this, he was the Senior Vice President of Technical Operations with Paratek Pharmaceuticals and over the years has worked at Eagle Pharmaceuticals, Shire with aaiPharma, Elan Pharmaceuticals, Sandoz, and Mylan Pharmaceuticals.
  • Previously, he was Vice President, Technical Assessment and Senior Director for Business Development at Shire Pharmaceuticals to build the product pipeline and support Shire's strategic venture arm through investments.

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update

Retrieved on: 
Monday, March 11, 2024
Health, Pharmaceutical, Research, CFO, Patient, HAE, Health care, CBO, NDA, American Academy, KALV, Factor, MHRA, Clinical trial, Hereditary angioedema, Safety, Pharmacology, AAAAI, Fiscal year, Food, Pharmaceutical industry

(NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.

Key Points: 
  • (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.
  • Third Fiscal Quarter Financial Results:
    Revenue: No revenue was recognized for the three months ended January 31, 2024, or January 31, 2023.
  • The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials.
  • The decrease in the net cash and marketable securities position was due to cash consumption from operating expenses.

Voiant's Commitment to Quality Affirmed by FDA Inspection with No Findings Raised

Retrieved on: 
Tuesday, April 2, 2024
FDA, Documentation, NDA, Food

WALTHAM, Mass., April 2, 2024 /PRNewswire-PRWeb/ -- Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA). The rigorous inspection encompassed an evaluation of the company's procedures, organizational structure, Voiant's imaging platform: Voiant Hub, and the entire trial data process—from the moment of images receipt from clinical sites to the secure transfer of data endpoints to sponsors, including data verification crucial for a New Drug Application (NDA).

Key Points: 
  • Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA).
  • WALTHAM, Mass., April 2, 2024 /PRNewswire-PRWeb/ -- Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA).
  • Laura Guzman, VP of QA and Regulatory Compliance at Voiant "We are delighted to receive such positive feedback from the FDA inspectors.
  • This successful inspection not only underscores Voiant's unwavering commitment to quality but also enhances the company's standing as a reliable partner in the journey from clinical trials to market-ready pharmaceuticals.