VEGF

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

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пятница, мая 26, 2023
Disease, CRC, Progression-free survival, TAK, New Drug Application, JAMA, NDA, American Medical Association, VEGF, Journal, Patient, PDUFA, BSC, Phase, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda

OSAKA, Japan and CAMBRIDGE, Mass. and HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted priority review of the New Drug Application (“NDA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.1,2 The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.

Key Points: 
  • — Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 —
    OSAKA, Japan and CAMBRIDGE, Mass.
  • “We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China.
  • “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients.

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

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четверг, мая 25, 2023
Research, FDA, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Disease, CRC, Progression-free survival, TAK, New Drug Application, JAMA, NDA, PFS, American Medical Association, VEGF, Journal, Patient, VEGFR, PDUFA, BSC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
  • “We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China.
  • “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients.

Daiichi Sankyo Showcases Latest Research Towards Creating New Standards of Care for Patients with Cancer with Data at ASCO and EHA

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четверг, мая 25, 2023
Biotechnology, Pharmaceutical, Health, Oncology, LBA, HER2, Neoplasm, Cancer, Breast, Multimedia, Medicine, Research, NSCLC, Immunotherapy, Carboplatin, Acute myeloid leukemia, ASCO, VEGF, AML, MD, Patient, Daiichi Sankyo, EHA, Dato, ADC, CDT, R, JST, Biliary tract, Pembrolizumab, PARP, Sarah Cannon Research Institute, Fine chemical, Pharmaceutical industry, Medical imaging

Data from DESTINY-PanTumor02 will be featured in an ASCO press briefing.

Key Points: 
  • Data from DESTINY-PanTumor02 will be featured in an ASCO press briefing.
  • “Our data at ASCO and EHA represent another step forward in realizing our vision to create new standards of care for patients with cancer.
  • Executives from Daiichi Sankyo will provide an overview of the ASCO research data and address questions.
  • Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at 2023 ASCO include:

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2023

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четверг, мая 11, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Axys, Monoclonal antibody, US Foods, Interest, Crown Bioscience International, AbbVie, Quality of life, PDL, Rights, TKI, Research, NSCLC, Immunotherapy, Lung cancer, Forbes China Celebrity 100, Sale, Bayer Corporation, VEGF, Patient, Investment, EGFR, SMMT, Webcast, Knowledge, Entrepreneurship, PD-1, FDA, Woman, Summit, Collaboration, Phase, Compugen (company), Michelle, Pharmaceutical industry, Security (finance), Cryptocurrency, Management, Pfizer

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the first quarter ended March 31, 2023.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the first quarter ended March 31, 2023.
  • The Collaboration and License Agreement with Akeso closed on January 17, 2023 after going effective following customary waiting periods.
  • In exchange for these rights, Summit committed to an upfront payment of $500 million, which was paid in two installments.
  • Operating cash outflow for the three month ended March 31, 2023 and 2022 was $13.1 million and $19.0 million, respectively.

Summit Therapeutics Announces First Patient Treated in Phase III HARMONi Clinical Trial Evaluating Ivonescimab (SMT112)

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вторник, мая 9, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Progression-free survival, Lung cancer, TKI, NSCLC, Carboplatin, Immunotherapy, Institutional review board, PFS, Trial of the century, VEGF, Patient, EGFR, TME, SMMT, Neoplasm, PD-1, FDA, Courage, Phase, Pemetrexed, Tumor microenvironment, Safety, Pharmaceutical industry, Nursing, Medical imaging, Paranal Observatory

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study.
  • HARMONi is a Phase III multiregional, randomized, double-blinded study.
  • Specifically, the study will compare ivonescimab combined with pemetrexed and carboplatin chemotherapies against a placebo plus pemetrexed and carboplatin.
  • Over 750 patients have been treated with ivonescimab across multiple clinical studies in China and Australia.

Agenus Provides Corporate Update and First Quarter 2023 Financial Results

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вторник, мая 9, 2023
Oncology, Health, Stem Cells, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Pancreatic cancer, Inc., AACR, Gastrointestinal cancer, Oxaliplatin, Survival, ESMO, Platinum, BRAF, ASAP, TESLA, II, ASCO, MRD, VEGF, RAS, EGFR, Colorectal cancer, Doxorubicin, Irinotecan, Annual general meeting, Mink, Growth, FDA, Ovarian cancer, Therapy, Combination, Safety, Pharmaceutical industry, Holding company, Agenus, Patient

Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of clinical and preclinical-stage cancer treatments, today provided a corporate update and reported financial results for the first quarter 2023.

Key Points: 
  • Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of clinical and preclinical-stage cancer treatments, today provided a corporate update and reported financial results for the first quarter 2023.
  • These results suggest that botensilimab could provide significant benefit to patients who have not responded to or failed other available treatments,” said Dr. Garo Armen, Chief Executive Officer of Agenus.
  • “Agenus is committed to advancing our development programs to make botensilimab available to patients ASAP."
  • First Quarter 2023 Financial Results:
    We ended our first quarter 2023 with a cash, cash equivalent and short-term investment balance of $189.2 million, compared to $193.4 million at December 31, 2022.

Apellis Pharmaceuticals Reports First Quarter 2023 Financial Results

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четверг, мая 4, 2023
Retina, Prescription Drug User Fee Act, ALS, Travel, Swedish Orphan Biovitrum, APLS, Stargardt disease, AMD, European Medicines Agency, Clinical trial, CAD, Geographic atrophy, Stargardt, Cold agglutinin disease, Research, GA, DSM-IV codes, C3, VALIANT, VEGF, Shanda, Patient, Physician, Data, Administration, PEGASUS, PNH, PDUFA, Webcast, United Kingdom, R, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, Mobile phone, Pharmaceutical industry, Nursing, Sewage treatment, Video game, Medical device, EU, Health, G&A, OAKS

EMPAVELI for the treatment of PNH:

Key Points: 
  • EMPAVELI for the treatment of PNH:
    Apellis recorded $20.4 million in EMPAVELI U.S. net product revenue for the first quarter 2023.
  • Cost of sales were $7.8 million for the first quarter 2023, compared to $1.2 million for same period in 2022.
  • Apellis reported a net loss of $177.8 million for the first quarter 2023, compared to a net loss of $138.9 million for the same period in 2022.
  • Apellis will host a conference call and webcast to discuss its first quarter 2023 financial results and business highlights today, May 4, 2023, at 4:30 p.m.

Summit Therapeutics Announces Initial Indications for Clinical Trials for Ivonescimab (SMT112)

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среда, мая 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, US Food Sovereignty Alliance, Quality of life, TKI, NSCLC, Paranal Observatory, Lung cancer, Immunotherapy, VEGF, Patient, EGFR, TME, SMMT, Knowledge, PD-1, FDA, Tumor microenvironment, Food, Safety, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has determined its first two indications in non-small cell lung cancer (NSCLC) in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has determined its first two indications in non-small cell lung cancer (NSCLC) in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab.
  • “I am immensely proud of the speed and efficiency of our team to enable clinical trials for SMT112,” stated Robert W. Duggan, Chairman & Chief Executive Officer of Summit.
  • “I am particularly enthusiastic about the potential of ivonescimab: this shared enthusiasm is the impetus behind Team Summit’s rapid development to enter into multiple Phase III clinical trials with SMT112.
  • Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position.

Skyline Therapeutics to Present at the ASGCT 26th Annual Meeting

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среда, мая 3, 2023
SMN, SMA, RNV, Gene, Anti-VEGF, CNV, NAMD, Clinical trial, SMN1, Toxicity, AAV, CNS, DSM-IV codes, IVT, VEGF, Neuromuscular junction, Patient, Kaay Raav Tumhi, Annual general meeting, Cell, NMJ, American Society of Gene and Cell Therapy, Liver, NHP, Therapy, Society, Human, A-DNA, Choroidal neovascularization, Pharmaceutical industry, Vaccine

SHANGHAI, May 3, 2023 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company dedicated to developing unique and novel solutions to address unmet needs in rare and severe diseases, today announced multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles, CA, May 16-20, 2023.

Key Points: 
  • SHANGHAI, May 3, 2023 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company dedicated to developing unique and novel solutions to address unmet needs in rare and severe diseases, today announced multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles, CA, May 16-20, 2023.
  • SKG0106 is a proprietary AAV vector carrying a transgene genome encoding a novel anti-VEGF protein.
  • Upon delivery, SKG0106 effectively and specifically suppresses the action of human VEGF, a key factor contributing to the pathological angiogenesis in the eyes of nAMD patients.
  • SKG0201 is a novel AAV-mediated gene replacement therapy comprising an optimized human SMN1 cDNA under the control of a unique promoter.

CBIH Announces the Completion of the “Phase of Research and Discovery" for Its Phytotherapy Cancer Scientific Project

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понедельник, мая 1, 2023
Inhalation, Neoplasm, CHNC, Cannabinoid, Quality of life, Research, Biomarker, Doctor of Philosophy, VEGF, Patient, Immune system, Growth, American Cancer Society, Pharmaceutical industry, Science, Cancer, MD

As a result of this research phase, CBIH´s group of scientists has developed a series of formulation proposals for the different cancer stages (from I to IV).

Key Points: 
  • As a result of this research phase, CBIH´s group of scientists has developed a series of formulation proposals for the different cancer stages (from I to IV).
  • These formulations include prototypes of different routes of administration; oral, oromucousal, sublingual, topical, inhalation, rectal, and vaginal route.
  • “The American Cancer Society has projected that the United States will see 1,958,310 new cancer cases and 609,820 cancer-related deaths in 2023.
  • CBIH expects to advance in new approaches to combat this persistent and frighteningly escalating global health concern with this non-clinical development phase.