Olaratumab

Telix Pharmaceuticals Announces Licence Agreement with Lilly for Olaratumab

Retrieved on: 
Sunday, April 10, 2022
Cancer, LinkedIn, TGA, American Cancer Society, Human, Degenerative disease, Partnership, Metastasis, Diagnosis, Marketing, Forward-looking statement, Sarcoma, Multimedia, Olaratumab, Overalls, STS, Survival, Research, Program, Prognosis, Incidence, Achievement, Death, Doxorubicin, Food, TLX, ASX, Australian Securities Exchange, Industry, Safety, MTR, Eli Lilly and Company, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PDGFR, FDA, Acquisition, Patient, Gallium, Pharmaceutical industry, Vaccine, Animal, Company, Telix, EU, Lilly

MELBOURNE, Australia and INDIANAPOLIS, April 10, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, "Telix", the "Company") today announces that it has entered into a licence agreement with Eli Lilly and Company ("Lilly") under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers.

Key Points: 
  • MELBOURNE, Australia and INDIANAPOLIS, April 10, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, "Telix", the "Company") today announces that it has entered into a licence agreement with Eli Lilly and Company ("Lilly") under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers.
  • The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer.
  • The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix.
  • Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis.

2020 Insights into the Global Soft Tissue Sarcoma Market and Competitive Landscape - ResearchAndMarkets.com

Retrieved on: 
Thursday, October 1, 2020
Pharmaceutical, Health, Oncology, Neoplasms, Health, Clinical medicine, Soft-tissue sarcoma, Sarcoma, SARC, Olaratumab, Epithelioid sarcoma

The "Global Soft Tissue Sarcoma Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Soft Tissue Sarcoma Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights into the Soft Tissue Sarcoma pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.
  • This research covers the following: Soft Tissue Sarcoma treatment options, Soft Tissue Sarcoma late stage clinical trials pipeline, Soft Tissue Sarcoma prevalence by countries, Soft Tissue Sarcoma market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.
  • Soft Tissue Sarcoma pipeline: Find out drugs in clinical trials for the treatment of Soft Tissue Sarcoma by development phase 3, phase 2, and phase 1, by pharmacological class and company
    Soft Tissue Sarcoma drugs: Identify key drugs marketed and prescribed for Soft Tissue Sarcoma in the US, including trade name, molecule name, and company
    Soft Tissue Sarcoma drugs sales: Find out the sales value for Soft Tissue Sarcoma drugs by countries
    Soft Tissue Sarcoma market valuations: Find out the market size for Soft Tissue Sarcoma drugs in 2019 by countries.

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma

Retrieved on: 
Thursday, September 17, 2020
Health, Clinical medicine, Medicine, RTT, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Cancer, Melanoma, Nasopharyngeal carcinoma, Sarcoma, Olaratumab

The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

Key Points: 
  • The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.
  • Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types and obvious tumor heterogeneity.
  • The current clinical treatment of soft tissue sarcoma mainly uses cytotoxic anti-tumor drugs, which have significant adverse reactions and poor tolerance.
  • Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA in September 2020.

FDA Lifts All Clinical Holds on Seladelpar

Retrieved on: 
Thursday, July 23, 2020
Health, Breakthrough therapy, Orphan drugs, Olaratumab, Elexacaftor/tezacaftor/ivacaftor

The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold.

Key Points: 
  • The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold.
  • The expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study and unanimously supported re-initiating clinical development of seladelpar pending approval by the FDA.
  • For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA).
  • Seladelpar also received Breakthrough Therapy Designation from the FDA and PRIority MEdicine status from the EMA for PBC.

A new FDA Fast Track designation for Zambon

Retrieved on: 
Tuesday, April 28, 2020
Biotechnology, FDA, Pharmaceutical, Health, Health, Articles, Pharmaceutical industry, Fast track, Orphan drugs, Priority review, Food and Drug Administration, New Drug Application, Accelerated approval, Breakthrough therapy, Olaratumab, Zambon S.p.A., Breath Therapeutics, a Zambon company

LCsAi, developed by Breath Therapeutics which was acquired by Zambon in 2019, previously received orphan drug designation from the FDA and European Medicines Agency for the treatment of BOS.

Key Points: 
  • LCsAi, developed by Breath Therapeutics which was acquired by Zambon in 2019, previously received orphan drug designation from the FDA and European Medicines Agency for the treatment of BOS.
  • We believe Fast Track designation provides an opportunity for frequent interactions with the FDA which may potentially expedite the development and registration of LCsAi, said Paola Castellani, CMO at Zambon.
  • Fast Track Designation may allow a therapy to be eligible for several benefits including enhanced interaction with the FDA and the potential for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) filing, if relevant criteria are met.
  • Additional information about FDA Fast Track designation is available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated... .

CytoDyn Files Request with FDA for Preliminary Meeting for Breakthrough Therapy Designation for Leronlimab in the Treatment of Cancer

Retrieved on: 
Friday, April 3, 2020
Health, Articles, Breakthrough therapy, Orphan drugs, Food and Drug Administration, United States Public Health Service, Fast track, Sacituzumab govitecan, Olaratumab

The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC.

Key Points: 
  • The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC.
  • Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.
  • Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.