Tags : Kite

Kite Reports sBLA Submission to the US FDA for Yescarta

Shots: The sBLA submission is based on an ongoing P-II ZUMA-5 study assessing single infusion of Yescarta in ~160 patients (≥18 yrs.) with r/r indolent NHL of either FL or marginal zone lymphoma subtypes, prior treated with 2L therapies, including an anti-CD20 mAb combined with an alkylating agent The 1EPs of the study is ORR […]Read More

PharmaShots Weekly Snapshot (Aug 31 – Sept 04, 2020)

1. AbbVie to License I-Mab’s Lemzoparlimab (TJC4) for ~$2B Published: Sept 04, 2020 | Tags: AbbVie, License, I-Mab, Lemzoparlimab, (TJC4), ~$2B 2. Kite and HiFiBiO Therapeutics Collaborate to Develop Antibodies Targeting Acute Myeloid Leukemia Published: Sept 03, 2020 | Tags: Kite, HiFiBiO Therapeutics, Collaborate, Antibodies, Targeting, Acute Myeloid Leukemia 3. Abbott Initiates LIFE-BTK Trial to […]Read More

Weekly Snapshot Jul 27- 31, 2020

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease  Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium […]Read More

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87% patients responded to Tecartus (single infusion), including 62 % patients […]Read More

PharmaShots Weekly Snapshot (April 20 -24, 2020)

1. Sanofi Receives the US FDA’s Approval for its MenQuadfi Meningococcal (MenACWY) Conjugate Vaccine Published: Apr 23, 2020 | Tags: Sanofi, Receives, US, FDA, Approval, MenQuadfi, Meningococcal, MenACWY, Conjugate Vaccine 2.  Takeda to Divest Select OTC and Non-Core Assets in Europe to Orifarm for $670M Published: Apr 24, 2020 | Tags: Takeda, Divest, Select OTC and […]Read More

Gilead and Kite Sign a Three Years Agreement with oNKo-innate

Shots: oNKo-innate to receive an up front, clinical, regulatory & commercial milestones along with royalties on sales of immuno-oncology and cell therapy programs while in exchange, the company will utilize its genome-wide screening techniques and technology platform to discover novel immune cell targets enhancing NK cell anti-tumor immunity and to create NK cell therapies oNKo-innate […]Read More

PharmaShots Weekly Snapshot (February 10-14, 2020)

1. Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma Published: Feb 14, 2020 | Tags: Epizyme, Reports, US, FDA, Acceptance, NDA, Tazverik, tazemetostat, Follicular Lymphoma 2. Soligenix’s RiVax Receives the US FDA’s Fast Track Designation for the Prevention of Ricin Poisoning Published: Feb 13, 2020 | Tags: Soligenix, RiVax, Receives, […]Read More

Kite’s KTE-X19 Receives the US FDA’s Priority Review for Relapsed

Shots: The US FDA has accepted BLA and granted PR designation to Kite’s KTE-X19 for the treatment of patients with r/r MCL The BLA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with r/r MCL following up to prior 5L therapies including an anthracycline, bendamustine-containing CT, anti-CD20 mAb and the […]Read More

PharmaShots Weekly Snapshot (January 27-31, 2020)

ProQR’s QR-421a Receives FDA’s Rare Pediatric Disease Designation for Retinitis Pigmentosa Published: Jan 30, 2020 | Tags: ProQR, QR-421a, Receives, FDA, Rare Pediatric Disease Designation, Retinitis Pigmentosa 2. Eli Lilly’s Fast-Acting Insulin Lispro Receives CHMP’s Positive Opinion in Patients with Diabetes Published: Jan 31, 2020 | Tags: Eli Lilly, Fast Acting Insulin Lispro, Receives, CHMP, Positive Opinion, […]Read More