Tags : Daiichi

Weekly Snapshot (Jul 06 – 10, 2020)

1. LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis Published Date: Jul 10, 2020 | Tags: LEO, Reports, US, FDA, Acceptance, BLA, Tralokinumab, Treat, Adults, Moderate to Severe, Atopic Dermatitis 2. Philips Collaborates with BioIntelliSense to Enhance Remote Patient Monitoring Published Date:  Jul 10, […]Read More

Insights+: Key Events of ASCO 2020 Virtual Annual Meeting #ASCO20

The American Society of Clinical Oncology (ASCO) is a platform for cancer experts to share views on the latest advancements and new approaches in cancer research and was held virtually this year due to the COVID-19 pandemic. The program features over 250 virtual oral abstract presentations and virtual 2,500 poster presentations in 24 disease-based and […]Read More

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US

Shots: The US FDA’s BT designation is based on an ongoing P-II DESTINY-Lung01 study assessing Enhertu in 170 patients with HER2 mutant or HER2 overexpressing unresectable and m-nsq. NSCLC, progressed after one or more systemic therapies including CT, molecular targeted therapy or immunotherapy and data from P-I study, published in Cancer Discovery The overall safety […]Read More

Immunic Exercises its Worldwide Exclusive Option to License for IMU-856

Shots: Immunic has exercised its exclusive option to license a group of compounds for Daiichi’s IMU-856. Daiichi to receive up front, certain future development, approval & sales milestone payments plus royalties on IMU-856. Immunic to get exclusive commercialization rights for IMU-856 in all countries, including the US, EU, and Japan Additionally, the option includes patent […]Read More

PharmaShots Weekly Snapshot (October 14-18, 2019)

1. Johnson & Johnson Initiates Voluntarily Recall of a Single Lot of its Baby Powder in the US Published: Oct 18, 2019 | Tags: JnJ, Initiates, Voluntarily, Recall, Baby Powder, US 2. AbbVie’s Rinvoq (Upadacitinib) Receives CHMP Positive Opinion to Treat Moderate to Severe Active Rheumatoid Arthritis Published: Oct 18, 2019 | Tags: AbbVie, Rinvoq, Upadacitinib, Receives, […]Read More

AstraZeneca and Daiichi Report the US FDA’s Acceptance of BLA

Shots: The BLA submission is based on P-I study and the pivotal P-II DESTINY-Breast01 study. The P-II DESTINY-Breast01 study assessing Trastuzumab deruxtecan in 253 patients with HER2+ unresectable/metastatic breast cancer prior treated with Trastuzumab Emtansine The US FDA has granted Priority Review to Trastuzumab deruxtecan to treat patients with HER2+ mBC with its expected PDUFA date […]Read More

Exelixis and Daiichi Report Launch of Minnebro (Esaxerenone) Tablets for

Shots: The approval of Minnebro (Esaxerenone) tablets (1.25/2.5/5 mg) is based on P-III ESAX-HTN study in patients with hypertension, with its regulatory approval submitted to MHLW in Feb’18 In Q2’19, Exelixis will receive $20M as milestone payment from Daiichi, as per their research collaboration for the development of therapies targeting mineralocorticoid receptor signed in 2006 […]Read More

AstraZeneca and Daiichi Report Results of Trastuzumab Deruxtecan (DS-8201) in

Shots: The P-II DESTINY-Breast01 study involves assessing of Trastuzumab Deruxtecan (DS-8201) in 253 patients with HER2+ unresectable and/or m-breast cancer prior treated with trastuzumab emtansine The P-II DESTINY-Breast01 study result: met its 1EPs; safe & tolerable as in previous trials; supporting the onset of FDA’s BLA submission in H2’19 Trastuzumab Deruxtecan (DS-8201) is an ADC, […]Read More

Daiichi Signs an Exclusive License Agreement with Esperion, for $1.2B

Shots: Esperion to receive $150M upfront, $150M sales milestones and up to $900M regulatory milestones including royalties. Daiichi to get exclusive commercialization rights for Esperion’s bempedoic acid and bempedoic acid /ezetimibe drug in EU and Switzerland Esperion plans for the file NDA and MAA for bempedoic acid / ezetimibe to the US FDA and EMA […]Read More