AstraZeneca & Daiichi drug wins another FDA approval, this time in lung cancer
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein […]
AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer […]
A Texas court has confirmed the $41.8 million damages awarded to Seagen in its patent dispute with Daiichi Sankyo over beast cancer drug Enhertu, but […]
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
Byondis has filed its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the US and Europe, setting up possible approvals next year and a showdown with […]
Eradicating cancer is an ambitious goal for oncologists and life science companies around the world. But, with a growing number of cancer treatments entering the […]
Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial […]
In February, AstraZeneca and Daiichi Sankyo teased the results of their pivotal trial of Enhertu in HER2-low breast cancer, and, at ASCO, they finally revealed […]
During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer […]
The US Securities and Exchange Commission has sued a former AstraZeneca executive over alleged insider trading in connection with its 2019 deal to acquire rights […]
A study that will look at the feasibility of tracking people’s lifestyle habits for an extended period using a wearable device has got underway in […]
AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients […]
AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu […]
A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 […]
Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels […]
Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 […]
What does the current picture of cardiovascular disease in Europe look like? Surprisingly for many, cardiovascular disease (CVD) is Europe’s leading cause of death – […]
Just over a decade after being acquired by Daiichi Sankyo, US biotech Plexxikon will be shuttered at the end of March, with its R&D projects […]
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The […]
AstraZeneca and Daiichi Sankyo have reported new data with their antibody-drug conjugate for triple-negative breast cancer (TNBC), as they build a case to challenge Gilead’s […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, […]
Shots: The P-III QuANTUM-First trial evaluates quizartinib vs placebo in combination with standard induction and consolidation CT & continued with quizartinib as monothx. in a […]
The EMA has started its review of AstraZeneca and Daiichi Sankyo’s Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer. If […]
Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive […]
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, […]
The dominance of Merck & Co’s Keytruda in the treatment of previously-untreated non-small cell lung cancer (NSCLC) means it will be hard to dislodge – […]
Shots: The companies collaborated to evaluate datopotamab deruxtecan + Keytruda vs Keytruda alone in P-III TROPION-Lung08 trial in ~740 patients with PD-L1 high advanced or […]
Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough […]
AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they […]
Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer […]
In an interview with PharmaShots, Ken Keller, President and Chief Executive Officer at Daiichi Sankyo and Global Head of the Daiichi Sankyo Oncology Business shared his […]
Shots: Esperion to receive $30M up front, ~$175M as sales milestones along with royalties from 5-20% on sales in the territory. Daiichi Sankyo will get […]
NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European […]
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal […]
Shots: The first patient has been dosed in a P-II two-part OLE study that assesses the safety, efficacy, and PK of Pexidartinib {800mg/day (400mg, bid […]
Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, […]
Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL […]
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
Shots: LYSA-LYSARC to conduct a P-II study to evaluate the safety and efficacy of valemetostat in six cohorts of patients with r/r B-cell lymphoma. The […]
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, […]
Shots: Daiichi Sankyo signs an outsourcing Agreement to Manufacture AstraZeneca COVID-19 Vaccine AZD1222 in Japan Following the AstraZeneca’s agreement with the Japanese government to manufacture […]
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, […]
Shots: The P-II HERTHENA-Lung01 study involves assessing patritumab deruxtecan in 420 patients in a ratio (1:1) with EGFR-mutated m/ LA NSCLC prior treated with TKI […]
AstraZeneca and Daiichi Sankyo have announced data from two drugs in lung cancer, which they are developing as part of their ongoing partnership. Results announced […]
Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, […]
Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research […]
Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with […]
Biohaven’s Troriluzole Dwindles Again In Alzheimer’s After Anxiety Biohaven Pharmaceuticals had put too much faith in its third-generation prodrug, Troriluzole. The company has tested the […]
Shots: The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult […]
AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin […]
MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin […]
Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine […]
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which […]
The Scottish Medicines Consortium (SMC) has rejected Daiichi Sankyo’s new cholesterol-lowering drug Nilemdo for use by NHS Scotland, saying the evidence backing the drug isn’t […]
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, […]
Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC […]
Shots: The new agreement involves, Daiichi to get royalties on sales of Movantik plus payments each year starting from 2021 to 2023. RedHill to take […]
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed […]
AstraZeneca has begun a new agreement with Daiichi Sankyo to develop and market an antibody to treat cancer, worth up to $6 billion. The deal […]
Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab […]
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