VEGF

EQS-News: Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®

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суббота, декабря 30, 2023
NAMD, Quality of life, Partnership, Eye, Risk, Teva Canada, Retina, Paratriathlon, Blood, Visual impairment, AMD, VEGF, OECD, Genentech, Health Canada, Ranibizumab, NOC, Growth, Supervisory board, Patient, Generic drug

Press Release // December 07, 2023

Key Points: 
  • Press Release // December 07, 2023
    Munich, Amsterdam, Zug, Toronto – Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto®1 (Ranibizumab), a biosimilar to Lucentis®2, for the treatment of several serious retinal diseases in Canada.
  • Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries.
  • Commercial launch by Teva Canada Ltd. is expected to start in the first quarter of 2024.
  • “The approval in Canada underlines the excellent work we have done together with our partners in the development of FYB201/Ranopto®.

Clearside Biomedical Reports Significant Progress in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD

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четверг, декабря 14, 2023
Axitinib, AMD, Injection, VEGF, Pharming, Eye, TKI, OASIS, Patient, Pharmaceutical industry

ALPHARETTA, Ga., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD). Topline data results are expected in the third quarter of 2024.

Key Points: 
  • ALPHARETTA, Ga., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).
  • Topline data results are expected in the third quarter of 2024.
  • “As we continue to make significant progress in our ODYSSEY trial, we are optimistic about the potential benefits of CLS-AX, our proprietary suspension of axitinib for suprachoroidal injection,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.
  • “Axitinib is a highly-potent tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.

EQS-News: Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

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среда, декабря 27, 2023
European Medicines Agency, VEGF, EMA, Retina, Ranibizumab, AMD, Marketing, Aflibercept, MAA, Patient

Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Key Points: 
  • Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
    The issuer is solely responsible for the content of this announcement.
  • Press Release // December 27, 2023
    Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea®(Aflibercept)
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea®1 (Active Ingredient: Aflibercept), for review.
  • Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases.
  • "The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition.

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

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пятница, декабря 15, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, MSD, Medicine, DSM-IV codes, PD-L1, NYSE, Potassium, Food, Progression-free survival, RECIST, Merck & Co., Head, Pneumonia, Blood transfusion, Dana–Farber Cancer Institute, Risk, Lymphocyte, Hypoxia, Everolimus, Bleeding, IMDC, Fatigue, Sepsis, Patient, Pregnancy, PFS, Effectiveness, Belzutifan, Week, VHL, VEGF, RCC, COVID-19, PD-1, Creatinine, TKI, ORR, Harvard Medical School, Death, Anemia, Fatal, Sodium, Hospital, Pleural effusion, HIV disease progression rates, MRK, Pharmaceutical industry, Birth control, Merck

Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.

Key Points: 
  • Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.
  • Patients could have received up to three prior treatment regimens and were required to have measurable disease per RECIST v1.1.
  • Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
  • Adverse reactions that required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%).

FRUZAQLA™ (fruquintinib) Now Available from Onco360 for the Treatment of Adult Patients with Metastatic Colorectal Cancer (mCRC)

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вторник, ноября 21, 2023
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Lancet, National Cancer Institute, Jazz Pharmaceuticals, Takeda, CRC, Specialty pharmacy, Anti-VEGF, VEGFR-3, Mortality, Patient, Pharmacy, Large intestine, VEGF, Caregiver, PharMerica, Colorectal cancer, Cancer, Diagnosis, Metastasis, Death, Hospital, Irinotecan, JAMA, Pharmaceutical industry

Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.

Key Points: 
  • Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.
  • Colorectal cancer is the fourth most frequent diagnosed cancer and second leading cause of death in the U.S.
  • Fruquintinib vs Placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicenter, randomized double blind, phase 3 study.
  • Effect of fruquintinib vs Placebo on overall survival in patients with previously treated metastatic colorectal cancer.

MEI Pharma Reports First Quarter Fiscal Year 2024 Results and Operational Highlights

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четверг, ноября 9, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bevacizumab, MEI, Glycolysis, Colorectal cancer, Acute myeloid leukemia, Lymphoid leukemia, ASH, Cohort, Investment, Patient, Research, CDK9, Calendar, Wind, VEGF, Exposition, Cancer, AML, Society, Neoplasm, OXPHOS, Venetoclax, Kyowa Kirin, Pharmaceutical industry, Cryptocurrency

The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.

Key Points: 
  • The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
  • For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022.
  • Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022.
  • MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022.

Inhibitor Therapeutics, Inc. Exclusive License with Johns Hopkins University

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среда, декабря 13, 2023
Licensing factor, Johns Hopkins University, FGF, HUVEC, Inhibitor, JHU, Itraconazole, Basal-cell carcinoma, Therapy, National Cancer Institute, VDAC1, INTI, Literature, Cell proliferation, Patient, BCC, EGF, Angiogenesis inhibitor, Prostate cancer, Endothelium, AMPK, VEGF, Neoplasm, System, License, Blood, Enzyme inhibitor, Cancer, ATP, Lung cancer, Growth, API, Metastasis, Invention, RNA, Patent, Pharmaceutical industry, Vaccine

TAMPA, Fla., Dec. 13, 2023 /PRNewswire/ -- Inhibitor Therapeutics, Inc. ("Inhibitor") (OTCQB: INTI) has entered into an exclusive, worldwide licensing agreement (the "License") with Johns Hopkins University (JHU) for their U.S Patent 8,980,930 (Canada Patent 2,572,223) "New Angiogenesis Inhibitors". Angiogenesis Inhibitors, as described by the National Cancer Institute, are unique cancer fighting agents as they block the growth of blood vessels that support tumor growth rather than blocking the growth of the tumor cells themselves. Inventors affiliated with JHU developed this patent, listing Itraconazole as an Active Pharmaceutical Ingredient (API) that has anti-angiogenic properties.

Key Points: 
  • TAMPA, Fla., Dec. 13, 2023 /PRNewswire/ -- Inhibitor Therapeutics, Inc. ("Inhibitor") (OTCQB: INTI) has entered into an exclusive, worldwide licensing agreement (the "License") with Johns Hopkins University (JHU) for their U.S Patent 8,980,930 (Canada Patent 2,572,223) "New Angiogenesis Inhibitors".
  • Inventors affiliated with JHU developed this patent, listing Itraconazole as an Active Pharmaceutical Ingredient (API) that has anti-angiogenic properties.
  • Inhibitor believes the License is a mutually beneficial agreement, yielding a modest annual royalty rate with milestone payments typical to such a license.
  • A total of 13 new 'surgically eligible' lesions across 8 of the 38 patients developed over the duration of the study.

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

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понедельник, декабря 11, 2023
Urine, Reproduction, Skeleton, Headache, PSA, Kidney, Erythroderma, Patient, Pharmacy, Birth, Nephrotic syndrome, MBA, Cancer, Miscarriage, Safety, Incidence, VTE, Bevacizumab, Corneal opacity, Wound healing, VEGFR2, Gastrointestinal perforation, Hemoptysis, Female, Fetus, CHF, Celltrion, Pharming, Necrotizing fasciitis, Heart failure, Fistula, Risk, Tracheoesophageal fistula, Bleeding, Organogenesis, Partnership, Rhinitis, Hypertension, Primary ovarian insufficiency, Back pain, Pregnancy, Glioblastoma, PRES, Nosebleed, Skull, FDA, ATE, VEGF, MBM, Hypertensive encephalopathy, Toxicity, Nursing, Pharmaceutical industry, Birth control, Dietary supplement, Proteinuria

Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.

HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

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четверг, ноября 9, 2023
Survival, HKEX, FDA, VEGF, Eli Lilly and Company, RAS, PDUFA, Food, American Medical Association, Colorectal cancer, Priority, European Medicines Agency, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Journal, Priority review, Quality of life, CRC, Medicine, Partnership, FACP, Cancer, Metastasis, Patient, Diagnosis, Vanderbilt University Medical Center, EGFR, Anti-VEGF, Pharmaceutical industry, Takeda, Lancet

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that its partner Takeda received approval from the U.S. Food and Drug Administration (“FDA”) for FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (“VEGF”) therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.1,2 This approval was received under Priority Review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30, 2023.

Key Points: 
  • The FDA approval of FRUZAQLA triggers a US$35 million milestone payment from Takeda.
  • Fruquintinib is developed and marketed in China by HUTCHMED following approval in September 2018, under the brand name ELUNATE™, in partnership with Eli Lilly and Company.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023 .

PharmAbcine Receives Safety Review Committee Approval to Advance to Dose Level 2 of Clinical Trial of PMC-403 with Neovascular Age-related Macular Degeneration following Dose Level 1 Safety Data

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четверг, ноября 9, 2023
KOSDAQ, VEGF, MTD, Trial of the century, Ageing, BVCA, Mall of America, MRF, Index, SRC, The Company, Blood, Safety, Visual acuity, Patient, TIE2, Pharmaceutical industry

Safety Review Committee evaluated dose level 1 safety data of PMC-403 and approved advancing to the higher dose treatment.

Key Points: 
  • Safety Review Committee evaluated dose level 1 safety data of PMC-403 and approved advancing to the higher dose treatment.
  • The starting dose (0.7mg) of PMC-403 showed potential in improving eyesight for neovascular age-related macular degeneration patients with suboptimal response to currently available therapies.
  • In this clinical study, a maximum of 36 patients with neovascular age-related macular degeneration with suboptimal response to currently available therapy will be evaluated for safety and maximum tolerated dose (MTD) of PMC-403.
  • The SRC reviewed the clinical data for dose level 1, and all of the SRC members agreed to advance to the dose level 2.