Pyrazoles

Xenikos Announces T-Guard® Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives

Retrieved on: 
Monday, July 19, 2021

Xenikos expects to commence this Phase 3 study in the second half of 2021.

Key Points: 
  • Xenikos expects to commence this Phase 3 study in the second half of 2021.
  • Initiate new Phase 3 study evaluating T-Guard versus ruxolitinib in patients with SR-aGVHD following allo-HSCT in the second half of 2021.
  • Complete safety run-in phase of Phase 3 study mid 2022.
  • Mehdi Hamadani, Protocol Officer, Scientific Director of CIBMTR, Medical College of Wisconsin; John Levine, Protocol Co-chair, Director of BMT Clinical Research, Mt.

Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease

Retrieved on: 
Wednesday, July 14, 2021

Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD, said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte.

Key Points: 
  • Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD, said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte.
  • BAT arms were thrombocytopenia (15.2% vs. 10.1%), anemia (12.7% vs. 7.6%), neutropenia (8.5% vs. 3.8%) and pneumonia (8.5% vs. 9.5%).
  • Mortality rates were similar across treatment arms (18.8% in the ruxolitinib arm vs. 16.5% in the BAT arm)1.
  • Deaths reported as primarily due to chronic GVHD complications and/or its treatment were higher in the ruxolitinib vs.

FMC Corporation Granted Interim Injunction Against Agricultural Chemicals Manufacturer Natco for Patent Infringement

Retrieved on: 
Wednesday, July 7, 2021

FMC Corporation (NYSE: FMC), an agricultural sciences company, announced the Delhi High Court today granted the company an interim injunction against NATCO Pharma Limited ("Natco").

Key Points: 
  • FMC Corporation (NYSE: FMC), an agricultural sciences company, announced the Delhi High Court today granted the company an interim injunction against NATCO Pharma Limited ("Natco").
  • The interim injunction restrains Natco from manufacturing, using, distributing, advertising, exporting, offering to sell and/or selling any product which contains chlorantraniliprole, FMC's leading insect control active ingredient.
  • FMC filed the lawsuit against Natco at the Delhi High Court in October 2019 for potential patent infringement of certain Indian patents covering chlorantraniliprole.
  • FMC sells chlorantraniliprole in India under the trade name Rynaxapyr active, which is the primary ingredient in Coragen and Ferterra insecticides.

China Ruxolitinib Market Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 17, 2021

The "Investigation Report on China's Ruxolitinib Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Ruxolitinib Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • According to the market research, the sales value of Ruxolitinib in China has increased year by year from 2017 to 2020, with the highest growth rate of Ruxolitinib in 2020 (4030%).
  • Due to the growth of indications in Ruxolitinib in China, the market will also expand and sales will continue to rise.
  • 2 Sales of Ruxolitinib in China, 2017-2020
    2.3 Sales of Ruxolitinib by Dosage Form in China, 2017-2020
    3 Analysis of Major Ruxolitinib Manufacturers in China, 2017-2020
    4 Prices of Ruxolitinib for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Ruxolitinib drug Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005469/en/

Corcept Therapeutics Settles Patent Litigation with Sun Pharmaceutical

Retrieved on: 
Tuesday, June 15, 2021

The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.

Key Points: 
  • The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.
  • As required by law, Corcept and Sun will submit the agreement to theUnited States Federal Trade Commission(FTC) and theUnited States Department of Justice(DOJ) for review.
  • Similar patent litigation brought byCorceptagainst two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.
  • Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol.

Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference

Retrieved on: 
Saturday, June 12, 2021

Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.
  • We are pleased to be sharing new data from our Phase 3 TRuE-AD program at the RAD Virtual Conference.
  • These data provide additional insights on the potential role ruxolitinib cream could play as a treatment option for patients living with atopic dermatitis.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis

Retrieved on: 
Friday, June 11, 2021

Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).

Key Points: 
  • Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).
  • The FDA extended the PDUFA action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDAs information request.
  • Ruxolitinib cream is a proprietary formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)

Retrieved on: 
Friday, May 28, 2021

News of this potential new treatment will be welcomed by the FOP community, and we await further updates from the FDA.

Key Points: 
  • News of this potential new treatment will be welcomed by the FOP community, and we await further updates from the FDA.
  • Palovarotene is an oral investigational, selective retinoic-acid receptor gamma (RAR) agonist being developed as a potential treatment for people living with the debilitating ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP).
  • Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a record linkage of two national databases.
  • An efficacy and safety study of palovarotene for the treatment of fibrodysplasia ossificans progressiva.

Global Fipronil Market is Estimated to Account For US$ 605.9 Mn By End of 2027, Says Coherent Market Insights (CMI)

Retrieved on: 
Tuesday, May 18, 2021

Fipronil belongs to a group of insecticides called antifungal pesticides which include Terpenes, Atovaquone, Isopropyl, Isomocyan, Styva, and Balsam.

Key Points: 
  • Fipronil belongs to a group of insecticides called antifungal pesticides which include Terpenes, Atovaquone, Isopropyl, Isomocyan, Styva, and Balsam.
  • It has been commonly used as Desitin, Fipronil, Proxindol, and Verserin.\nThe global fipronil market is estimated to account for US$ 605.9 Mn in terms of value by the end of 2027, witnessing a CAGR of 2.9%.\nThe growing adoption of modern agriculture techniques is driving the growth of the fipronil market.
  • According to the Economic Research Service, in 2019, food spending by U.S. consumers, businesses, and government entities totaled $1.77 trillion.
  • In September 2020, the production of key chemicals was 8, 36,435 MT and petrochemicals were 17, 26,502 MT.\nKey companies operating in the global fipronil market include BASF SE, Parijat Industries (India) Pvt.

Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo

Retrieved on: 
Monday, May 17, 2021

The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data , and no new safety signals were observed.

Key Points: 
  • The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data , and no new safety signals were observed.
  • \xe2\x80\x9cWe look forward to working with regulators to bring this much needed treatment option to patients.
  • Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).