Oxaliplatin

Ipsen delivers strong sales in the first quarter of 2024, driven by growth platforms & new medicines, and confirms its full-year guidance

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水曜日, 4月 24, 2024
Core, FDA, Ipsen, Food, Pancreatic cancer, Oxaliplatin, RNA, Webcast, Patent, ADC, District court, Fluorouracil, Patient, Paragraph, Dicarboxylic acid, DSM-IV codes, Therapy, CER1, Growth, Pharmaceutical industry

“The delivery of our strategic plan continues to be evidenced by a strong top line, supported by the success of the growth platforms and the increased contribution of the new medicines.

Key Points: 
  • “The delivery of our strategic plan continues to be evidenced by a strong top line, supported by the success of the growth platforms and the increased contribution of the new medicines.
  • Moreover, the pipeline continues to deliver, illustrated this quarter by the regulatory approval in the U.S. of Onivyde as a first-line treatment for pancreatic cancer.
  • “This year marks a pivotal period for our growth plans, with the launches of four new medicines or indications.
  • In April 2024, Ipsen announced an exclusive global licensing agreement for STRO-003, an antibody-drug conjugate (ADC) targeting the ROR1 tumor antigen.

Panbela Therapeutics Announces Interim Data Analysis for ASPIRE Trial Pushed to Q1 2025

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月曜日, 4月 22, 2024
MSN, Safety, Protein-bound paclitaxel, OTCQB, Prognosis, Survival, Oxaliplatin, Doctor of Philosophy, Therapy, Patient, Fluorouracil, Dicarboxylic acid, Data analysis, PBLA, Pharmaceutical industry

MINNEAPOLIS, April 22, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), (“Panbela”), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as Q1 2025.

Key Points: 
  • MINNEAPOLIS, April 22, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), (“Panbela”), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as Q1 2025.
  • As of the latest assessment, less than half of the required events for the interim analysis have occurred.
  • "The early indications from the ASPIRE trial support this belief, and we remain committed to advancing this important study and look forward to sharing the interim results in March 2025."
  • Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.

Genentech’s Columvi Meets Primary Endpoint of Overall Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Study

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月曜日, 4月 15, 2024
Research, FDA, Genetics, Clinical Trials, Stem Cells, Biotechnology, Pharmaceutical, Health, Science, Oncology, Phase, Safety, DLBCL, Risk, Food, European Commission, ROG, Survival, Oxaliplatin, Roche, Aggressive lymphoma, Disease, Rituximab, Patient, Civil service commission, GemOx, Diagnosis, B-cell lymphoma, Pharmaceutical industry

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival.
  • Safety of the combination appeared consistent with the known safety profiles of the individual medicines.
  • The data will be submitted to health authorities and shared at an upcoming medical meeting.
  • Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, so patients can start treatment soon after diagnosis.

Onchilles Pharma Presents at AACR 2024 New Preclinical Data for N17350 and N17465 Demonstrating the Potential for Potent and Tumor-Selective Treatment

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火曜日, 4月 9, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cancer, Pharma, Blood, Doxorubicin, Oxaliplatin, Breast, San Diego Convention Center, CDX, Prostate cancer, Death domain, Therapy, Immunogenic cell death, Patient, Neoplasm, ICD, Lung, Toxicity, AACR, Immune system, Carboplatin, Ovarian cancer, CD95, Vaccine

N17350 and N17465 are novel first-in-class oncology programs that harness the potent efficacy of the innate immune system and have the potential to become a major new treatment modality for a wide range of cancer types.

Key Points: 
  • N17350 and N17465 are novel first-in-class oncology programs that harness the potent efficacy of the innate immune system and have the potential to become a major new treatment modality for a wide range of cancer types.
  • Lev Becker, Ph.D., Scientific Founder, Onchilles Pharma, said, “We are excited to unveil systemically delivered N17465 that has the potential to redefine the treatment of solid tumors.
  • The data presented today demonstrate that N17465 exhibits potent and tumor-selective efficacy, mobilizes the immune system for anti-tumor immunity, and produces durable responses in mouse models as a monotherapy.
  • We are confident that N17350 and N17465 represent a novel class of molecules that could become the new foundation of cancer treatment.

GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

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金曜日, 4月 19, 2024
FDA, Total, Colorectal cancer, Mutation, Immunology, Lung cancer, Priority review, NMPA, National Medical Products Administration, Cetuximab, Progression-free survival, New Drug Application, Irinotecan, Oxaliplatin, Recurrence, RAS, CRC, ESMO, Medicine, ASCO, Canadian International Council, Disease, Incidence, Patient, Liver, Peritoneum, Food and Drug Administration, BTD, Lung, Death, Biology, Clinical trial, EGFR, Therapy, Cancer, NSCLC, Breakthrough therapy, Prevalence, Pharmaceutical industry

"We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.

Key Points: 
  • "We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.
  • We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients.
  • Targeting KRAS G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver, International Journal of Molecular Science, Mar.
  • Disease Burden of Total and Early-Onset Colorectal Cancer in China from 1990 to 2019 and Predictions of Cancer Incidence and Mortality, Clinical Epidemiology, Feb. 2023
    4.

Summary of opinion: Onivyde pegylated liposomal (previously known as Onivyde), 21/03/2024 Positive

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水曜日, 4月 3, 2024
European Commission, Civil service commission, Patient, Irinotecan, Oxaliplatin, Committee, Dicarboxylic acid, Medication package insert, Marketing, CHMP, Pancreas

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.
  • The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
  • Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
  • 1New text in bold

Summary of opinion: Onivyde pegylated liposomal (previously known as Onivyde), 21/03/2024 Positive

Retrieved on: 
水曜日, 4月 3, 2024
European Commission, Civil service commission, Patient, Irinotecan, Oxaliplatin, Committee, Dicarboxylic acid, Medication package insert, Marketing, CHMP, Pancreas

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.
  • The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
  • Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
  • 1New text in bold

Summary of opinion: Onivyde pegylated liposomal (previously known as Onivyde), 21/03/2024 Positive

Retrieved on: 
水曜日, 4月 3, 2024
European Commission, Civil service commission, Patient, Irinotecan, Oxaliplatin, Committee, Dicarboxylic acid, Medication package insert, Marketing, CHMP, Pancreas

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.
  • The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
  • Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
  • 1New text in bold

FibroGen Appoints Deyaa Adib, M.D. as Chief Medical Officer

Retrieved on: 
月曜日, 3月 11, 2024
Therapy, Breast cancer, SAN, Pharmacology, ARIAD Pharmaceuticals, Biotechnology, Baxalta, Bone marrow, Drug development, Prostate, Acute leukemia, Acting, Stomach, Sanofi, Oxaliplatin, Astellas Pharma, Patient, Oncology, Qasr El Eyni Hospital, Stromal cell, Pancreatic cancer, IND, Head, Colorectal cancer, Cancer, Prostate cancer, Medical imaging

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities.
  • “Deyaa’s leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be key to accelerating our oncology pipeline and bringing novel cancer therapies to patients in need,” said Thane Wettig, Chief Executive Officer of FibroGen.
  • “We will benefit immensely from Deyaa’s broad and deep experience in oncology drug development, including his experiences in both pancreatic and prostate cancers.”
    “I am excited to join FibroGen and lead the clinical development organization at this important time for our company,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • Prior to joining FibroGen, he was the Chief Medical Officer of Triumvira Immunologics Inc. where he led the transition of two novel cell therapy programs into clinical development.

Merrimack Reports Full Year 2023 Financial Results

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木曜日, 3月 7, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Investment, FDA, Food, Sale, Irinotecan, Dissolution, Oxaliplatin, Pancreas, Medication

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (“Merrimack” or the “Company”) today announced its full year 2023 financial results for the period ended December 31, 2023.

Key Points: 
  • Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (“Merrimack” or the “Company”) today announced its full year 2023 financial results for the period ended December 31, 2023.
  • “This approval triggers a $225 million payment which is due from Ipsen to Merrimack before the end of March.
  • As of December 31, 2023, Merrimack had cash, cash equivalents and short-term investments of $18.9 million, compared to $19.4 million as of December 31, 2022.
  • As of December 31, 2023, Merrimack had 14.4 million shares of common stock outstanding.