• Contact us
  • Advertise with us
  • Login
Tashi Pharma
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
No Result
View All Result
Home Global Pharma News

US FDA grants Priority Review to Mobocertinib of Takeda

PRN by PRN
April 28, 2021
in Global Pharma News
28 0
0
Sun Pharma recalls batches of Ganirelix Acetate Injection & Metformin HCl Extended-Release Tablets from US market
18
SHARES
43
VIEWS

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

Mobocertinib is an investigational, first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Center for Drug Evaluation (CDE) for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who have been previously treated with at least one prior systemic chemotherapy.

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. The application was submitted under the FDA’s accelerated approval program. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

Tags: fdaPharma NewspharmacyPharmareg NewsTakeda
Previous Post

Syngene reports revenue from operations growth of 13% in the fourth quarter; 12% for the full year

Next Post

US FDA Advisory Committee votes in favour of Roche’s Tecentriq

PRN

PRN

Related Posts

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine
Global Pharma News

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

by admin
February 23, 2022
NDAs of Sandoz Inc have been acquired by ANI Pharmaceuticals
Global Pharma News

Sandoz launches generic lenalidomide in 19 countries across Europe

by admin
February 20, 2022
Revenue of Pfizer up by 95% for year 2021
Global Pharma News

Revenue of Pfizer up by 95% for year 2021

by admin
February 16, 2022
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Global Pharma News

FDA Authorizes New Monoclonal Antibody that Retains Activity Against Omicron Variant

by admin
February 12, 2022
WHO prequalifies first monoclonal antibody - tocilizumab – to treat COVID-19
Global Pharma News

WHO prequalifies first monoclonal antibody – tocilizumab – to treat COVID-19

by admin
February 12, 2022
Next Post
Roche provides update on tominersen programme in manifest Huntington’s disease

US FDA Advisory Committee votes in favour of Roche’s Tecentriq

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Recent News

Zydus to launch Oxemia

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

March 6, 2022
FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

US FDA publishes guidance on Initiation of Voluntary Recalls

March 5, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

March 5, 2022

Browse by Category

  • Articles
  • Company Focus
  • EDQM
  • EMA
  • European Commision
  • Global Pharma News
  • Guideline News
  • Health Canada
  • Indian Pharma News
  • Interview
  • Medsafe
  • MHRA
  • SAHPRA
  • US FDA
  • Webinar

Browse by Tags

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Contact us

Address:Pharma Reg News, First floor, Shop no.1 , Plot no 241,242, Near Fire station, GIDC, Ankleshwar, Gujarat - 393002.
Phone:+91 8511586232, +91 9029066605
Email:author@pharmaregnews.com

Browse by Tag

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Advertise with us

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • bioanalytical
    • Clinical
  • Webinar
  • Contact us
  • Advertise with us
  • Login

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Are you sure want to unlock this post?
Unlock left : 0
Are you sure want to cancel subscription?