Pemetrexed

Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study

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Mercredi, janvier 18, 2023
NSCLC, Large-cell lung carcinoma, Independent Review Committee, Survival rate, Shanghai Chest Hospital, World Health Organization, IRC, DFS, New Drug Application, Lung cancer, IDMC, Trial of the century, Blind, Death, Safety, HKEX, Pemetrexed, SSE, Immune system, Patient, Diagnosis, Survival, Cisplatin, Mortality, Cancer, Research, Chain reaction, EFS, Recurrence, III, Paclitaxel, Pharmaceutical industry

The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.

Key Points: 
  • The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.
  • Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental New Drug Application in the near future.
  • Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients.
  • Based on the interim analysis, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for phase III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter may significantly extend EFS of patients.

Eagle Pharmaceuticals Provides Business Update and Guidance for 2023

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Mardi, janvier 10, 2023
M&A, Apnea, EBITDA, Pemetrexed, Growth, Eagle, Security (finance), Video game, Pharmaceutical industry

WOODCLIFF LAKE, N.J., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided a business update and guidance for 2023.

Key Points: 
  • WOODCLIFF LAKE, N.J., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today provided a business update and guidance for 2023.
  • Q4 2022 expiration of development partner royalty on the bendamustine franchise profits (BENDEKA®, BELRAPZO® & TREAKISYM®), representing approximately 10% of such profits.
  • In addition, we expect the 2023 decline in bendamustine to be manageable, and the 10% royalty on bendamustine products no longer applies.
  • These efforts, together with our intention to further expand the Company, including M&A, lead us to believe that Eagle is poised for another year of strong earnings growth and profitability in 2023,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy

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Lundi, décembre 19, 2022
Eli Lilly and Company, Pembrolizumab, Food, LLY, Regulation of tobacco by the U.S. Food and Drug Administration, Pemetrexed, Eagle, Platinum, ALK, Patient, NYSE, FDA, Large-cell lung carcinoma, Patent, Mesothelioma, New Drug Application, Pharmaceutical industry

WOODCLIFF LAKE, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

Key Points: 
  • Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.
  • “With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution.
  • At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
  • In February 2020, Eagle received approval from the FDA of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019.

NuCana Reports Third Quarter 2022 Financial Results and Provides Business Update

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Mercredi, novembre 16, 2022
Protide, Immunogenic cell death, PD-1, NSCLC, Docetaxel, Oxaliplatin, European Society for Medical Oncology, Large-cell lung carcinoma, Melanoma, Patient, Neoplasm, Adenocarcinoma, Pembrolizumab, Oncology, Irinotecan, Thymidylate synthase, NCNA, Commencement (album), Security (finance), ESMO, Colorectal cancer, Cancer, Therapy, Pemetrexed, Bevacizumab, Organic acid, Pharmaceutical industry, Medical imaging, Food delivery

EDINBURGH, United Kingdom, Nov. 16, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics.

Key Points: 
  • EDINBURGH, United Kingdom, Nov. 16, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the third quarter ended September 30, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics.
  • As of September 30, 2022, NuCana had cash and cash equivalents of 50.8 million compared to 46.5 million as of June 30, 2022 and 60.3 million at December 31, 2021.
  • NuCana continues to advance its various clinical programs and reported a net loss of 4.5 million for the quarter ended September 30, 2022, as compared to a net loss of 8.0 million for the quarter ended September 30, 2021.
  • Basic and diluted loss per share was 0.09 for the quarter ended September 30, 2022, as compared to 0.15 per share for the quarter ended September 30, 2021.

Immutep Announces Promising Initial Clinical Data from INSIGHT-003 at SITC 2022

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Jeudi, novembre 10, 2022
GLOBE, Carboplatin, Immunotherapy, Society for Immunotherapy of Cancer, IMM, NASDAQ, INSIGHT, Pemetrexed, Cancer, ASX, Pembrolizumab, Patient, TPS, NSCLC, Autoimmune disease, Society, SITC, Pharmaceutical industry

SYDNEY, AUSTRALIA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging initial clinical data from the investigator-initiated INSIGHT-003 trial has been published in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022. INSIGHT-003 is the first trial evaluating Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) as part of a triple combination therapy with standard-of-care anti-PD-1 therapy and chemotherapy.

Key Points: 
  • SYDNEY, AUSTRALIA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep or the Company), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging initial clinical data from the investigator-initiated INSIGHT-003 trial has been published in a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022.
  • The poster entitled Feasibility of eftilagimod alpha (soluble LAG-3 protein) combined with standard-of-care-therapy in advanced non-small-cell lung cancer (NSCLC).
  • Immuteps CEO Marc Voigt also added: We are encouraged to see these promising initial results from INSIGHT-003.
  • Table 1: ORR and DCR for INSIGHT-003 (data cut-off date: 14 October 2022)

NuCana Presents Positive Data on NUC-3373 at the 34th EORTC-NCI-AACR Annual Meeting 2022

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Mercredi, octobre 26, 2022
ICD, SEC, Company, Squamous cell carcinoma, Security (finance), U.S. Securities and Exchange Commission, Bevacizumab, Damage-associated molecular pattern, NASDAQ, CRC, Private Securities Litigation Reform Act, DNA, Cancer, Lung cancer, Goal, Forward-looking statement, DNA repair, Terminology, Pemetrexed, Large-cell lung carcinoma, Immunotherapy, Docetaxel, Protide, Pembrolizumab, Patient, PD-1, Immunogenic cell death, GLOBE, FOLFIRI, Thymidylate synthase, NCNA, Adenocarcinoma, Vaccine, Pharmaceutical industry, NSCLC

BARCELONA, Spain, Oct. 26, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced non-clinical data from two poster presentations at the 34th EORTC-NCI-AACR Annual Meeting being held from October 26 to 28, 2022.

Key Points: 
  • BARCELONA, Spain, Oct. 26, 2022 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced non-clinical data from two poster presentations at the 34th EORTC-NCI-AACR Annual Meeting being held from October 26 to 28, 2022.
  • NUC-3373 generated high intracellular levels of the anti-cancer metabolite FUDR-MP, resulting in TS inhibition, and the DNA-targeting metabolite, FUDR-TP.
  • These data highlight that NUC-3373 may be an effective treatment for non-small cell lung cancer (NSCLC) regardless of histological subtype and basal TS expression.
  • NUC-3373 causes NSCLC cells to release damage associated molecular patterns (DAMPs), molecular signals that activate immune cells leading to immunogenic cell death (ICD).

Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small Cell Lung Cancer

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Mardi, septembre 20, 2022
OS, World, Safety, Lancet, ALK, PD-L2, Society, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Patient, Hospital, Somatic mutation, Research, Death, EUA, COVID-19, HKEX, NSCLC, National Medical Products Administration, Program, Ligand, SSE, Microbiology, NMPA, Mortality, EGFR, Peking Union Medical College, Autoimmunity, Junshi, Risk, FDA, ASCO, Social responsibility, Severe acute respiratory syndrome coronavirus 2, Bamlanivimab/etesevimab, Medicine, Progression-free survival, GLOBE, Marketing, Platinum, HIV disease progression rates, Cancer, Development, Incidence, World Health Organization, American Society of Clinical Oncology, Lung cancer, Pemetrexed, Lung, HR, PD-L1, PD-1, Bamlanivimab, Lilly, PFS, Infection, Pharmaceutical industry, Chinese, Science

This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

Key Points: 
  • This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.
  • Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimabs performance in clinical trials.
  • In China, the number of lung cancer patients is massive and so is the demand for treatment.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).

Accord Healthcare Adds Pemetrexed Injection to Generic Chemotherapy Drug Portfolio

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Mardi, septembre 13, 2022
Intas Biopharmaceuticals, Malignancy, Incidence, Mesothelioma, Ageing, Pemetrexed, Chest pain, Blistering, FDA, Solution, NSCLC, Vomiting, Population, MPM, Product, Lung cancer, Patient, Accord, Cancer, Technology, Heart, Research, Nausea, Fatigue, Chemotherapy, Pharmaceutical industry

DURHAM, N.C., Sept. 13, 2022 /PRNewswire/ -- Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Pemetrexed Injection (Solution) to its line of chemotherapy drugs. The new drug is formulated as a single-dose vial in 25-mg/ml concentrate for solution for infusion.

Key Points: 
  • DURHAM, N.C., Sept. 13, 2022 /PRNewswire/ --Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Pemetrexed Injection (Solution) to its line of chemotherapy drugs.
  • The new drug is formulated as a single-dose vial in 25-mg/ml concentrate for solution for infusion.
  • Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company.
  • Accord Healthcare combines its advanced manufacturing technology with in-house research to produce highly complex, affordable, and essential medicines.

Checkpoint Therapeutics Reports Second Quarter 2022 Financial Results and Recent Corporate Highlights

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Vendredi, août 12, 2022
FDA, U.S. Securities and Exchange Commission, Drug Quality and Security Act, Risk, GLOBE, ORR, Health care, Population, Fortress Biotech, European Medicines Agency, Private Securities Litigation Reform Act, Clinical trial, Securities Exchange Act of 1934, Patent, Society, Research, Annual report, Biologics license application, Pemetrexed, Patient, Marketing, COVID-19, Company, CSCC, D, EGFR, Acquisition, Data, NASDAQ, Chemistry, Dana–Farber Cancer Institute, BLA, Securities Act of 1933, CMC, Platinum, Regulation, CKPT, Pharmaceutical industry, Lithium

WALTHAM, Mass., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2022, and recent corporate highlights.

Key Points: 
  • WALTHAM, Mass., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2022, and recent corporate highlights.
  • In May 2022, Checkpoint announced that it received Pediatric Investigation Plan product-specific waivers from the European Medicines Agency and the U.K.
  • General and administrative expenses for the second quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.9 million for the second quarter of 2021.
  • Net loss for the second quarter of 2022 included $0.7 million of non-cash stock expenses, compared to $1.0 million for the second quarter of 2021.

HERTHENA-Lung02 Phase 3 Trial of Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

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Lundi, août 8, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ADC, International Agency for Research on Cancer, HIV disease progression rates, Survival, Safety, Veni, vidi, vici, Cardiovascular disease, World Health Organization, Sustainable development, Lung cancer, Carboplatin, Senior, Technology, Cisplatin, Organic, Breakthrough therapy, Pemetrexed, Immunoglobulin G, NSCLC, Patient, Quality of life, Cell proliferation, Trastuzumab deruxtecan, Large-cell lung carcinoma, EGFR, HER3, ClinicalTrials.gov, Patritumab, Cleavage, TSE, Doctor of Philosophy, TKI, Research, Lead, Daiichi Sankyo, BTD, Bachelor of Pharmacy, Lung, PFS, DXD, Progression-free survival, Food, Disease, Pharmaceutical industry, Fine chemical, Platinum, Silviculture, Cancer

Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

Key Points: 
  • Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.
  • Initiating this phase 3 trial emphasizes our ongoing commitment to accelerate development of patritumab deruxtecan to potentially improve the standard of care for patients with this specific subtype of lung cancer.
  • Patients will be randomized 1:1 to receive patritumab deruxtecan or platinum-based chemotherapy.
  • A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been recently completed.