PharmaShots Weekly Snapshots (October 25 – 29, 2021)
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
Shots: Health Canada has granted a NOC based on the P-II ZUMA-2 trial that evaluates Tecartus in 74 adult patients with r/r MCL who had […]
Shots: The approval was based on a P-I/II ZUMA-3 study assessing Tecartus in adult patients aged ≥18yrs. with ALL whose disease is refractory to or […]
This thought leadership series has been paid and developed by Kite, a Gilead Company. This Blood Cancer Awareness Month, Blood Cancer UK’s Kate Keightley explains […]
Shots: The company reported 2yrs. & 1 yrs. results from P-III KITE & KINGFISHER studies evaluating Beovu (6mg, q4w) vs aflibercept (2mg) in 926 patients […]
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
Shots: Appia Bio to receive $875M as an up front, equity investment, and milestone along with royalties. Kite will be responsible for the development, manufacturing, […]
Shots: Kite will receive a one-time upfront to purchase Kite’s individualized solid tumor neoantigen TCR discovery platform, R&D & clinical manufacturing facility in Gaithersburg. The […]
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, […]
Shots: Shoreline is eligible to receive ~$2.3B including upfront, development and commercialization milestones and additional payments along with royalties. The agreement follows Kite’s investment in […]
Shots: The P-II ZUMA-5 trial assessing Yescarta in 146 patients aged ≥18rs. with r/r iNHL include FL, prior treated with at least 2L of systemic […]
The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – […]
Shots: The company reported the 1yrs. results from the P-III KESTREL & KITE studies assessing Beovu (6mg) vs aflibercept (2mg) in 926 patients with DME […]
Dr. Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe […]
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron […]
Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult […]
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, […]
Lymphoma Action is the only UK health charity dedicated to people affected by lymphoma. Chief Executive Ropinder Gill and Director of Operations and External Affairs […]
Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with […]
NHS patients in England will be among the first in the world to receive Gilead’s Tecartus cancer cell therapy for certain types of lymphoma, after […]
Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell […]
Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni […]
Shots: The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 […]
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, […]
Shots: The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single […]
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 […]
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 […]
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