Tags : Incyte

Regulatory

Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval as the

Shots: The approval is based on P-II FIGHT-202 (NCT02924376) study which involves assessing of Pemazyre (13.5 mg, qd) in adults with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement The study has three cohorts: Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (March 30 – April 03, 2020)

1. Sorrento Initiates the Next Phase of its Collaboration with Celularity Published: Apr 02, 2020 | Tags: Sorrento, Initiates, Next Phase, Collaboration, Celularity 2.  Celltrion Enters the Next Phase of Development for its Antiviral Therapy to Combat COVID-19 Pandemic Published: Apr 03, 2020 | Tags: Celltrion, Enters, Next Phase, Development, Antiviral Therapy, Combat, COVID-19 Pandemic 3. […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (Dec 30, 2019-Jan 03, 2020)

1. RedHill Terminates its 2014 Deal with Salix Pharmaceuticals for RHB-106 Published: Jan 03, 2019 | Tags: 2014, Deal, RedHill, RHB-106, Salix Pharmaceuticals, Terminates 2. Innate’s Lumoxiti (moxetumomab pasudotox-tdfk) Receives EMA’s MAA to Treat Patients with Relapsed or Refractory Hairy Cell Leukemia Published: Jan 03, 2019 | Tags: EMA, Hairy Cell Leukemia, Innate, Lumoxit, MAA, […]Read More

Regulatory

Incyte Reports Acceptance and Priority Review of NDA for Pemigatinib

Shots: The NDA submission is based on P-II FIGHT-202 study assessing Pemigatinib in patients aged ≥ 18yrs. with previously treated, LA/metastatic cholangiocarcinoma with documented FGF/FGFR status The P-II FIGHT-202 study resulted in 36% ORR, 7.5mos. mDOR with a median follow-up of 15 mos. in patients harboring FGFR2 fusions or rearrangements. AEs are manageable and consistent […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (September 23– 27, 2019)

1. Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial for Patients with Previously Treated Advanced Cholangiocarcinoma Published: Sept 27, 2019 | Tags: Incyte, Reports, Updated, Results, Pemigatinib, P-II, FIGHT-202 Trial, Patients, Previously, Treated, Advanced, Cholangiocarcinoma 2.Pfizer Reports Results of Abrocitinib in P-III JADE MONO-2 Study for Moderate to Severe Atopic Dermatitis Published: Sept 27, 2019 […]Read More

Pharma

Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial

Shots: The P-II FIGHT-202 (NCT02924376) study involves assessing of pemigatinib (13.5 mg, qd) as monothx in adults patients previously treated, LA or metastatic cholangiocarcinoma with documented FGF/FGFR status divided into 3 cohorts: Cohort A (N=107, FGFR2 fusions or rearrangements), Cohort B (N=20, other FGF/FGFR genetic alterations) or Cohort C (N=18, no FGF/FGFR genetic alterations)   […]Read More