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Details:
Results are from an exploratory analysis of ABT-263 (navitoclax) plus ruxolitinib from Cohort 3 of the Phase 2 REFINE study in JAK inhibitor naïve myelofibrosis patients.
Lead Product(s): Navitoclax,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: ABT-263
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.
Lead Product(s): Navitoclax,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: ABT-263
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Details:
Novartis will begin to progress the integration of MorphoSys, including full access to CPI-0610 (pelabresib), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis.
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition May 16, 2024
Details:
Opzelura (ruxolitinib phosphate), a novel topical cream formulation with selective JAK1/JAK2 inhibitor, is in phase 2 trial for the treatment of adults with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2024
Details:
Through the acquisition, Novartis will strengthen its oncology pipeline with CPI-0610 (pelabresib), a novel and potentially practice changing treatment option with a well-tolerated safety profile provided in combination with ruxolitinib for patients with myelofibrosis (MF).
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $2,897.9 million Upfront Cash: $2,897.9 million
Deal Type: Acquisition February 05, 2024
Details:
CPI-0610 (pelabresib monohydrate) is an investigational BET inhibitor. It is being developed in combination with the JAK inhibitor ruxolitinib for the treatment of myelofibrosis.
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2023
Details:
Xpovio (selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of selective Inhibitor of Nuclear Export (SINE) compounds which down-regulates the levels of multiple oncogenic proteins, being developed for the treatment of cancer.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
Results showed that patients with AD treated with Opzelura (ruxolitinib) experienced a rapid and substantial improvement in itch, which was sustained and further improved through 28 days of treatment in patients with atopic dermatitis.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2023
Details:
Opzelura (ruxolitinib phosphate), a novel cream formulation, is the first and only topical JAK inhibitor approved for use in the UK indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2023
Details:
Xpovio (selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor and currently investigated in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2023
Details:
Voyager V-1 (VSV-IFNbeta-NIS) is based on the VSV platform. Voyager-V1 is designed for enhanced safety, efficacy, and traceability through the inclusion of the interferon beta gene, enabling the virus to: replicate quickly in cancer cells without damaging healthy cells.
Lead Product(s): VSV-IFNbeta-NIS,Ruxolitinib Phosphate,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Voyager-V1
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2023
Details:
Results showed that patients with AD treated with Opzelura (ruxolitinib) experienced a rapid and substantial improvement in itch, which was sustained and further improved through 28 days of treatment in patients with atopic dermatitis.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
Details:
Opzelura (ruxolitinib phosphate), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2023
Details:
Jakafi (ruxolitinib phosphate), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Jakafi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Details:
INCB050465 (parsaclisib) is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.
Lead Product(s): Parsaclisib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: INCB050465
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2023
Details:
Opzelura (ruxolitinib phosphate), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
Recently published results from a Phase 1 trial conducted by ONCOtherapeutics among 28 heavily previously treated MM patients administered RUX, lenalidomide (LEN) and MP demonstrated that the therapy was well tolerated and RUX overcame refractoriness to LEN and steroids.
Lead Product(s): Ruxolitinib Phosphate,Lenalidomide,Methylprednisolone
Therapeutic Area: Oncology Product Name: Jakafi
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
Phase 2 study of IMG-7289 (bomedemstat), an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor, in combination with ruxolitinib (Jakafi®) in people with myelofibrosis (MF) conducted at the Department of Medicine, Queen Mary Hospital.
Lead Product(s): Bomedemstat,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: IMG-7289
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
Opzelura™ (ruxolitinib phosphate), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CMS
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 02, 2022
Details:
XPOVIO (selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
NEXPOVIO (Selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor, functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1).
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Nexpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Menarini
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
Opzelura (ruxolitinib phosphate), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib approved by the U.S. FDA is used for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2022
Details:
Single-agent GRN163L (imetelstat) currently being studied in a separate Phase 3 trial designed to confirm clinically meaningful benefits observed in relapsed/refractory MF patients in Phase 2 study.
Lead Product(s): Imetelstat,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: GRN163L
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
Opzelura (ruxolitinib phosphate), is the first and only topical JAK inhibitor approved for use in the US, indicated for the topical treatment of nonsegmental vitiligo in adult and patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain proteins to decrease the expression of abnormally expressed genes in cancer.
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Encouraging initial data observed in phase 1/2 study of Nexpovio (selinexor) in combination with ruxolitinib in treatment-myelofibrosis, favorable tolerability with nodose-limitingg toxicities and 75% of evaluable patients demonstrating ≥35% spleen volume reduction at week 12.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Nexpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
XPOVIO (Selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
In clinical trials, Jakavi (ruxolitinib) demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GVHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: Jakavi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
In clinical trials, Jakavi (ruxolitinib) demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GvHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: Jakavi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Maruho will receive the rights to develop, manufacture and exclusively commercialize ruxolitinib cream, and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, in Japan.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maruho
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 28, 2022
Details:
XPOVIO is a first-in-class, oral exportin 1 inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1.
Lead Product(s): Selinexor,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: Nexpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Use of Opzelura™ (ruxolitinib cream), a topical JAK1/JAK2 inhibitor resulted in further improvement in facial and total body repigmentation at Week 52, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2022
Details:
Positive opinion from CHMP is based on data from Phase 3 REACH2 and REACH3 trials, demonstrated that Jakavi (ruxolitinib) improved response rates and failure-free survival compared to best available therapy, which provides a promising opportunity for patients living with GvHD.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: Jakavi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Details:
Opzelura a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is first and only topical JAK inhibitor approved for use in US for treatment of atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2022
Details:
The FDA extended the PDUFA action date to allow time to review additional data from the ongoing Phase 3 studies for Opzelura™(ruxolitinib), selective JAK1/JAK2 inhibitor for the treatment of vitiligo.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
Details:
Ruxolitinib cream (Opzelura) is JAK1/JAK2 inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis, currently shown ≥75% improvement from baseline in the facial Vitiligo area.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Opzelura
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2021
Details:
Data from the phase 3 program TRuE-V on ruxolitinib cream for vitiligo will be presented for the first time in an oral late-breaking presentation.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
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 has worldwide rights for the development and commercialization of ruxolitinib cream.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
Pelabresib durably reduced inflammatory cytokines such as tumor necrosis factor alpha (TNF alpha) and interleukin 18 (IL18) as early as 2 weeks and maintained through 24 weeks of treatment, based on an analysis of patient samples.
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF).
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2021
Details:
Constellation's lead product candidates, pelabresib (CPI-0610), a BET inhibitor, and CPI-0209, a 2nd-gen EZH2 inhibitor, are in mid- to late-stage clinical trials and have broad therapeutic potential to offer benefits to patients with various hematological and solid tumors.
Lead Product(s): Pelabresib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: CPI-0610
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition June 02, 2021
Details:
More than 14 abstracts, including new findings from Incyte’s clinical trial programs for ruxolitinib cream in patients with vitiligo and atopic dermatitis, to be presented.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2021
Details:
Expanded access program to allow eligible patients in the united states with covid-19 associated ARDS to receive ruxolitinib will be discussed with the U.S. food and drug administration.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: INCB018424
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
U.S. FDA has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2021
Details:
Recently published results from a Phase 1 trial for 28 heavily previously treated MM patients administered Ruxolitinib, lenalidomide and methylprednisolone demonstrated that the therapy was well tolerated and RUX overcame refractoriness to LEN and steroids.
Lead Product(s): Ruxolitinib Phosphate,Lenalidomide,Methylprednisolone
Therapeutic Area: Oncology Product Name: Jakafi
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2021
Details:
As per the terms of the agreement, the companies plan to initiate a Phase 1b single arm, open-label study evaluating ruxolitinib in combination with CK0804 in patients with myelofibrosis (MF).
Lead Product(s): Ruxolitinib Phosphate,CK0804
Therapeutic Area: Oncology Product Name: Jakafi
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: $294.5 million Upfront Cash: Undisclosed
Deal Type: Collaboration December 30, 2020
Details:
Novartis announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: INC424
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
Results reinforce that ruxolitinib cream treatment results in a rapid, substantial and sustained reduction in itch. Results also demonstrate improvement in patient-reported perceptions of sleep quality, sleep depth and restoration associated with sleep.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Dermatology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Immunology Product Name: Jakafi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2020
Details:
The Novartis trial, conducted in partnership with the pharmaceutical company Incyte, is a placebo-controlled treatment study with ruxolitinib that inhibits the JAK/STAT pathway, which is a channel of communication between proteins in a cell, Andes says.
Lead Product(s): Ruxolitinib Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: Jakavi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020