Tags : Jazz

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 […]Read More

PharmaShots Weekly Snapshot (Sept 07 -11, 2020)

1. Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis Published: Sept 10, 2020 | Tags:  Janssen, Tremfya, Guselkumab, Biologic, US FDA, Selective, IL-23 inhibitor, Active Psoriatic Arthritis, Severe Plaque Psoriasis, human mAb 2. Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab […]Read More

Jazz Collaborates with Redx Pharma to Develop Two Targeted Cancer

Shots: Redx to receive $10M as up front followed by another $10M in year two and will receive up to $400M as milestones along with royalties on sales of the therapies. The first milestone is payable following IND submission Following a successful IND submission, Jazz will be responsible for further development, manufacturing, regulatory activities, and […]Read More

PharmaMar and Jazz Receive the US FDA’s Priority Review Acceptance

Shots: The US FDA has accepted NDA filing with PR seeking accelerated approval for lurbinectedin to treat patients with SCLC having diseases progression following the prior treatment of platinum-containing therapy The NDA submission is based on P-II monotherapy basket study assessing lurbinectedin in 105 patients with SCLC at 39 centers across the US & EU […]Read More

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

Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to

Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in […]Read More