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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Shots: Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…
January 31, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
January 28, 2025

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Key Takeaways of J.P. Morgan Healthcare Conference 2025
INSIGHTS+

Key Takeaways of J.P. Morgan Healthcare Conference 2025

Shots:  The 43rd Annual J.P. Morgan Conference took place from 13th to 16th January in San Francisco, USA. J.P. Morgan Healthcare Conference serves as a pioneering hub that features presentations and dialogues on the advances of the healthcare industry by bringing healthcare professionals, researchers, manufacturers, and other healthcare stakeholders to one platform.   Innovation remained the…
January 28, 2025

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Viewpoints_Mina Makar
VIEWPOINTS

Cardiology Care and Beyond: Mina Makar from AstraZeneca in a Riveting Dialogue Exchange with PharmaShots

Shots: At ESC 2024, AstraZeneca presented insights from the real-world OverTTuRe study, exploring the challenges of early diagnosis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) Mina Makar, SVP and Commercial Lead of the Global Cardiovascular, Renal, and Metabolism (CVRM) Biopharmaceuticals Business Unit at AstraZeneca, shared real-world insights on how ATTR-CM manifests as cardiac symptoms Mina highlighted the…
January 27, 2025

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Astrazeneca
NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots: The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…
January 20, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots: The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…
January 20, 2025

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Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-mutated NSCLC

Shots: FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings…
January 15, 2025

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NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was…
January 9, 2025

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NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots:     The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway  Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain  Sipavibart was discovered…
January 9, 2025

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Viewpoints_Richard Watts
VIEWPOINTS

Enhancing Diagnostic Care: Richard Watts from Qiagen in a Stimulating Conversation with PharmaShots

Shots:  Recently, Qiagen entered into a collaboration agreement with AstraZeneca to develop companion diagnostics for chronic diseases using Qiagen’s QIAstat-Dx system  Today, at PharmaShots, we are joined by Richard Watts from Qiagen, who sheds light on their collaboration agreements with AstraZeneca and Eli Lilly, leveraging their syndromic testing platform, QIAstat-Dx  Qiagen has partnered with over…
November 27, 2024

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