The FDA has set a Prescription Drug User Fee Act (PDUFA) date of 30 November 2024. Credit: Tada Images via Shutterstock. A new drug application (NDA) from US-Ireland speciality pharmaceutical company Shorla Oncology has been accepted by the US Food and Drug Administration (FDA) for SH-201, an oral version of the related leukaemia chemotherapy drug. The regulatory agency will give a decision on the approval on 30 November 2024 under the Prescription Drug User Fee Act. Shorla obtained the rights to SH-201, previously named PIP-101, in July 2023 from an unnamed developer. Under the agreement, the developer was to continue to manufacture the drug until Shorla received an NDA. Shorla will now be responsible for the launch, commercialisation and sales of SH-201 in the US. SH-201 is an oral liquid drug, making the treatment accessible to patients who may struggle with taking tablets or other dosage forms. It slows or stops the growth of certain forms of leukaemia, including chronic myeloid leukaemia and acute lymphoblastic leukaemia. See Also: J&J and Legend’s Carvykti scores early line approval for MM by FDA FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for solid tumours According to a report on GlobalData’s Pharma Intelligence Center, there will be 17,562 cases of CML in the eight major markets (US, UK, Spain, France, Italy, Germany, Canada, and Japan) in 2030. GlobalData is the parent company of Pharmaceutical Technology. The company is headquartered in Ireland and has operations in the US. In October 2023, Shorla received $35m in Series B funding round led by Kurma Partners’ Growth Opportunities Fund to boost its oncology portfolio growth by advancing drug candidates such as SH-201. In March 2023, the FDA granted approval for Shorla’s Nelarabine injection (SH-111), an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The regulatory approval, which was indicated for T-cell lymphoblastic lymphoma (T-LBL) and T-cell acute lymphoblastic leukaemia (T-ALL), was the company’s first product to receive approval in the US market. Shorla added to its oncology portfolio by acquiring the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind for commercialisation in the US market in October 2023, approved in the US to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis. In the announcement accompanying the NDA, Shorla’s CEO Sharon Cunningham said: “With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of US patients diagnosed with leukaemia and other cancers who do not currently have the option of an oral liquid.”

上市批准申请上市引进/卖出

2021-05-06

·GlobeNewswire

T-cell Leukemia Pipeline: Comprehensive Analysis of 15+ Key

Los Angeles, USA, May 05, 2021 (GLOBE NEWSWIRE) -- T-cell Leukemia Pipeline: Comprehensive Analysis of 15+ Key Players and 15+ Key Therapies Out of all T-cell Leukemia pipeline therapies, HBI-8000 is set to capture the maximum patient pool owing to its immunomodulatory function. DelveInsight’s ‘T-cell Leukemia Pipeline Insights’ report provides a holistic view of the pipeline therapies that are under development in pre-clinical as well as clinical stages of development, and growth prospects across the T-cell Leukemia domain. Some of the key highlights of the T-cell Leukemia Pipeline report: Got queries? Want to know more? Request for Sample @ T-cell Leukemia Emerging Therapies and Forecast The report lays down a complete coverage of the therapeutics by development stage, product type, and route of administration, molecule type, and MOA type for T-cell Leukemia across the complete product development cycle, including all clinical and non-clinical stages. The T-cell Leukemia pipeline report puts on the table business opportunities, threats, prospective collaborations, strong competitors, growth strategies, and failed as well as discontinued drugs. T-cell Leukemia Pipeline Drugs Request for Sample to know more @ T-cell Leukemia Pipeline Analysis, Key Companies and Futuristic Trends T-cell Leukemia Therapeutic Assessment The T-cell Leukemia Pipeline report proffers exhaustive insights into active pipeline assets segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Get in touch with our Business executive for Rich and Deep Market Assessment and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Daiichi Sankyo; Bioniz; Otsuka Pharmaceutical; Seagen /Takeda; HUYA Bioscience; iCell Gene Therapeutics; Gracell Biotechnology; Ascentage Pharma Group; Celgene Corporation; Shorla Pharma; AVM Biotechnology; Expression Therapeutics; miRagen Therapeutics, and others.Key T-cell Leukemia Pipeline Therapies: Valemetostat; BNZ-1; ASTX 660; Brentuximab vedotin; HBI-8000; CD4CAR; CD7 UCAR-T cells; APG-115; Romidepsin; SH-111; Cobomarsen; AVM-0703, and others. Reach out @ T-cell Leukemia Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ T-cell Leukemia Emerging Therapies Browse through Related Reports CAR T-Cell Therapy for Acute Lymphoblastic LeukemiaDelveInsight’s “CAR T-Cell Therapy for Acute Lymphoblastic Leukemia (ALL)- Market Insights and Market Forecast- 2030” report. CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Pipeline DelveInsight’s, “CAR T-Cell Therapy for Acute Lymphoblastic Leukemia - Pipeline Insight, 2021,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in CAR T-Cell Therapy for Acute Lymphoblastic Leukemia pipeline landscape. Adult T Cell Leukemia Lymphoma MarketDelveInsight's "Adult T-Cell Leukemia-Lymphoma - Market Insights, Epidemiology, and Market Forecast-2030" report. Acute Myeloid Leukemia MarketDelveInsight's "Acute Myeloid Leukemia (AML) Market Insights, Epidemiology, and Market Forecast-2030" report. B-Cell Chronic Lymphocytic Leukemia MarketDelveInsight's "B-Cell Chronic Lymphocytic Leukemia - Market Insights, Epidemiology, and Market Forecast-2030" report. Hairy Cell Leukemia Market Insight Epidemiology and Market ForecastDelveInsight's 'Hairy Cell Leukemia (HCL)- Market Insights, Epidemiology and Market Forecast-2028' report. Bowens Disease MarketDelveInsight's "Bowen's Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Buergers Disease MarketDelveInsight's "Buerger’s Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Brucellosis MarketDelveInsight's "Brucellosis - Market Insights, Epidemiology, and Market Forecast-2030" report. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

细胞疗法合作

2021-04-23

·BioSpace

Shorla Pharma Announces FDA Filing Acceptance and Priority Review for T-cell Leukemia Treatment

April 23, 2021 07:00 UTC Biopharma company prepares for launch of first US product CLONMEL, Ireland--(BUSINESS WIRE)-- Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced today that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the company looks forward to working closely with FDA to bring this much needed product to market later this year. “We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukemia,” said Sharon Cunningham, CEO and Co-founder of Shorla Pharma. “It’s a desperately needed product and a life-changing treatment that we are honored to bring to patients in the United States, and later, worldwide.” Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, plus an extensive industry network that includes the Children’s Oncology Group in the U.S., the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs. T-cell leukemia is an aggressive blood and bone marrow cancer which progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children, with this particular treatment often in shortage. The expedited review granted for this filing recognizes the urgent need for the product. Added Orlaith Ryan, Shorla Pharma CTO and Co-founder, “Reaching this milestone is an important step as we continue to make progress across our growing pipeline. Our focus is on developing innovative oncology treatments for women and children, with a focus on rare cancers where existing treatments are limited, in short supply or inadequate.” The company is also developing a drug for treating breast and ovarian cancers, and an oral solution to treat patients with glioblastoma who have trouble swallowing. About Shorla Pharma Ltd Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Pharma Ltd is a privately held, specialty pharmaceutical company with an advanced pipeline of innovative oncology drugs for women's, orphan and pediatric cancers. The company concentrates on indications where existing treatments are limited, in shortage or inadequate for the target population. Shorla's growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. For further information, please visit . View source version on businesswire.com: Contacts Rachel Ford Hutman Rachel@fordhutmanmedia.com +1-301-801-5540 Source: Shorla Pharma Limited View this news release online at:

优先审批合作

100 项与 SH-111 相关的药物交易

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