T-cell leukemia

Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers

Retrieved on: 
Lunedì, Aprile 8, 2024
FDA, Pharmaceutical, Health, Oncology, Acute lymphoblastic leukemia, Growth, Disease, Caregiver, New Drug Application, Patient, Nelarabine, NDA, Breast, Leukemia, Agency, Cancer, T-cell leukemia, Adenocarcinoma, Ovary, Food, Pharmaceutical industry

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers.

Key Points: 
  • Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers.
  • The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of November 30, 2024.
  • “With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of U.S. patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid,” said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology.
  • The company recently raised $35 million in Series B funding that has allowed Shorla to accelerate the growth of its oncology portfolio.

Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States

Retrieved on: 
Giovedì, Luglio 6, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Partnership, T-cell leukemia, Acute lymphoblastic leukemia, New Drug Application, NDA, Acute leukemia, Patient, Growth, Leukemia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, today announced it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company.

Key Points: 
  • Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, today announced it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company.
  • “We are excited to partner with and leverage the developer’s oral oncology liquid manufacturing expertise,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology.
  • “This commercial partnership is a strong endorsement of our commitment to bring to market differentiated oncology treatments to address key areas of unmet needs for patients.”
    Under the terms of the agreement, the developer will continue to manufacture PIP-101.
  • Shorla also has plans to have three products on market and three or more in development by end of year 2024.

Shorla Oncology & EVERSANA Announce Commercial Launch of Recent FDA-Approved Nelarabine Injection for the Treatment of T-cell Leukemia Across the United States

Retrieved on: 
Martedì, Maggio 16, 2023
CHOP, T-cell acute lymphoblastic leukemia, Pharmacovigilance, Children's Hospital of Philadelphia, Hospital, Patient, Boxed warning, Cancer, T-ALL, Ageing, Leukemia, FDA, T-cell leukemia, Disease, Vaccine, Nursing, Pharmaceutical industry

CAMBRIDGE, Mass. and CHICAGO, May 16, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla'), a U.S.-Ireland pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of the company's oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) in adult and pediatric patients aged one year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Key Points: 
  • Nelarabine Injection, which received FDA approval in March of 2023, is now available for order through major wholesalers and specialty distribution partners.
  • Shorla Oncology selected EVERSANA to support the commercialization launch for the therapy in 2021.
  • "What a milestone for the Shorla Oncology team to officially have this new treatment option available to the oncology community across the U.S.," said Jim Lang, CEO, EVERSANA.
  • Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers.

Shorla Oncology Announces U.S. FDA Approval of Nelarabine Injection for the Treatment of T-cell Leukemia

Retrieved on: 
Martedì, Marzo 7, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, MD, T-cell leukemia, Research, Leukemia, T-ALL, Division, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, T-cell acute lymphoblastic leukemia, Patient, Cancer, Food, Childhood cancer, FDA, U.S. FDA, Pharmaceutical industry

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL).

Key Points: 
  • Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL).
  • Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage.
  • “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this U.S. FDA approval,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology.
  • “We are delighted to announce this first U.S. FDA approval for Shorla Oncology, and we look forward to a successful launch in the U.S.,” said Dennis Purcell, Chairman of the Board at Shorla.

US T-Cell Leukemia Market and Competitive Landscape - 2022 - ResearchAndMarkets.com

Retrieved on: 
Mercoledì, Ottobre 5, 2022
Biotechnology, Pharmaceutical, Health, Oncology, T-cell leukemia, Epidemiology, Competitive landscape, Research, Oil

The "US T-Cell Leukemia Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US T-Cell Leukemia Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.
  • The report US T-Cell Leukemia Market and Competitive Landscape Highlights - 2022, provides comprehensive insights into T-Cell Leukemia pipeline products, T-Cell Leukemia epidemiology, T-Cell Leukemia market valuations and forecast, T-Cell Leukemia drugs sales and competitive landscape in the US.
  • T-Cell Leukemia pipeline: Find out the products in clinical trials for the treatment of T-Cell Leukemia by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
    T-Cell Leukemia drugs: Identify key products marketed and prescribed for T-Cell Leukemia in the US, including trade name, molecule name, and company
    T-Cell Leukemia market valuations: Find out the market size for T-Cell Leukemia drugs in 2021 in the US.
  • Find out how the market advanced from 2019 and forecast to 2027
    T-Cell Leukemia drugs market share: Find out the market shares for key T-Cell Leukemia drugs in the US
    Evaluate commercial market opportunity assessment, positioning, and segmentation for T-Cell Leukemia products

HUYABIO Announces HBI-8000 Brand Name of Hiyasta™

Retrieved on: 
Giovedì, Giugno 24, 2021
Non-Hodgkin lymphoma, Medical specialties, Clinical medicine, Health, Lymphoma, Cancer, T-cell lymphoma, PMDA, T-cell leukemia, Leukemia

SAN DIEGO, June 24, 2021 /PRNewswire/ -- HUYABIO International (HUYABIO), the leader in acceleratingglobal development of China's pharmaceutical innovations, announced today that HBI-8000 will bemarketed under the brand name Hiyasta in Japan.

Key Points: 
  • SAN DIEGO, June 24, 2021 /PRNewswire/ -- HUYABIO International (HUYABIO), the leader in acceleratingglobal development of China's pharmaceutical innovations, announced today that HBI-8000 will bemarketed under the brand name Hiyasta in Japan.
  • Hiyasta was recently approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adult T-cell leukemia/lymphoma (ATLL) as monotherapy.
  • Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "Today's approval of Hiyasta for ATLLcame in just 9 months.
  • Hiyasta was also submitted to the PMDA in March for approval as monotherapy to treat peripheral T-cell lymphoma (PTCL).

Global T-Cell Leukemia Epidemiology and Patient Flow Analysis & Forecasts Report 2020-2035 - ResearchAndMarkets.com

Retrieved on: 
Mercoledì, Maggio 12, 2021
Health, Oncology, Lymphocytic leukemia, Medical specialties, Branches of biology, Clinical medicine, Leukemia, T cell, T-cell leukemia, Large granular lymphocytic leukemia, Lymphoid leukemia

b'The "Global T-Cell Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal T-Cell Leukemia Epidemiology and Patient Flow Analysis - 2021, provides T-Cell Leukemia epidemiology, demographics, and patient flow.

Key Points: 
  • b'The "Global T-Cell Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal T-Cell Leukemia Epidemiology and Patient Flow Analysis - 2021, provides T-Cell Leukemia epidemiology, demographics, and patient flow.
  • The data is presented by Pharma G7 countries including the US, France, Spain, Italy, UK, Japan.\nThe research provides population data to characterize T-Cell Leukemia patients, history of the disease at the population level (T-Cell Leukemia prevalence, T-Cell Leukemia incidence) and at the clinical level (from diagnosis to treated patients).
  • It also helps to identify patient sub-groups (age, gender, sub-groups) to understand targeted population for research and development, commercialization.\nDemographics: T-Cell Leukemia patients by age group, gender\nThe data from this research will help executives:\nEstablish basis for T-Cell Leukemia market sizing, assessing market potential, and developing drug forecast models\nIdentify T-Cell Leukemia patients segments through age groups, gender, and disease sub-types\nEvaluate T-Cell Leukemia market opportunities, identify target patient population\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210512005460/en/\n'

miRagen Announces Proposed Public Offering of Common Stock and Warrants to Purchase Common Stock

Retrieved on: 
Giovedì, Febbraio 6, 2020
Lymphoma, Medical specialties, Medicine, Non-Hodgkin lymphoma, RTT, Clinical medicine, Anatomical pathology, T-cell lymphoma, Cutaneous T cell lymphoma, Shelf registration, Security, T-cell leukemia

All of the common stock and warrants to purchase common stock are being offered by miRagen.

Key Points: 
  • All of the common stock and warrants to purchase common stock are being offered by miRagen.
  • This offering is being made pursuant to an effective shelf registration statement of miRagen filed with the Securities and Exchange Commission (the SEC).
  • miRagen is developing cobomarsen for the treatment of patients with certain cancers, including cutaneous T-cell lymphoma and adult T-cell leukemia/lymphoma.
  • miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.

miRagen Announces Major Changes to Company’s Strategy

Retrieved on: 
Mercoledì, Dicembre 11, 2019
Medical specialties, Non-Hodgkin lymphoma, Medicine, RTT, Branches of biology, Anatomical pathology, Lymphoma, T-cell lymphoma, Cutaneous T cell lymphoma, T-cell leukemia

Dr. Rubin remains excited about the potential of the Companys technology and will continue to provide guidance and advice to miRagen through a consulting arrangement.

Key Points: 
  • Dr. Rubin remains excited about the potential of the Companys technology and will continue to provide guidance and advice to miRagen through a consulting arrangement.
  • Aspire Capital has the obligation to purchase common stock from miRagen in amounts and based on timing determined by miRagen in its sole discretion, subject to certain limits.
  • miRagen is developing cobomarsen for the treatment of patients with certain cancers, including cutaneous T-cell lymphoma and adult T-cell leukemia/lymphoma.
  • miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.

Rafael Pharmaceuticals Enters into Collaboration with the National Institutes of Health (NIH) to Test CPI-613® (devimistat) in Cytokine Independent (Acute) HTLV-1 Associated Adult T-cell Leukemia/Lymphoma

Retrieved on: 
Giovedì, Ottobre 17, 2019
Cancer, Medical specialties, RTT, Acute lymphocytic leukemia, Medicine, Lymphoma, Lymphocytic leukemia, Adult T-cell leukemia/lymphoma, Human T-lymphotropic virus 1, Human T-lymphotropic virus, Leukemia, T-cell leukemia

This collaboration will test CPI-613 (devimistat), Rafaels first-in-class clinical lead compound, in cytokine independent (acute) HTLV-1 (human T-cell leukemia virus type 1) associated adult T-cell leukemia/lymphoma.

Key Points: 
  • This collaboration will test CPI-613 (devimistat), Rafaels first-in-class clinical lead compound, in cytokine independent (acute) HTLV-1 (human T-cell leukemia virus type 1) associated adult T-cell leukemia/lymphoma.
  • Devimistat targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells.
  • We are honored to enter into a collaboration with the NCI, said Sanjeev Luther, President and CEO of Rafael.
  • We strongly identify with their mission of fostering innovative research in order to protect and improve the health of the nation.