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)…

ByDipanshu DixitJanuary 20, 2025

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…

ByRidhi RastogiJanuary 15, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2024

Shots: The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity Our…

BySaurabh ChaubeyOctober 1, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

BySenior EditorJuly 2, 2024

TOP 20

Top 20 Life Sciences Deals of 2023 by Total Deal Value

Shots: Driven by mutual growth and expansion, strategic collaborations are embedded deeply in the modus operandi of life sciences deals. In 2023, the volume of life science deals was comparatively high vs. 2022 The collaboration deal between Daiichi Sankyo and Merck & Co. for $22B ranks first in our list followed by the development and…

ByPrince GiriFebruary 15, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2023

Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

BySenior EditorAugust 16, 2023

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases…

BySenior EditorApril 3, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in January 2023

Shots: The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis PharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 2023

INSIGHTS+

PharmaShots’ Most Read News of 2022

The year 2022 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, clinical trial results and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2022 1. AVEO Entered into a Clinical Trial Collaboration with Merck KGaA to…

BySenior EditorJanuary 2, 2023

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

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

PharmaShots’ Key Highlights of Third Quarter 2024

PharmaShots’ Key Highlights of Second Quarter 2024

Top 20 Life Sciences Deals of 2023 by Total Deal Value

PharmaShots’ Key Highlights of Third Quarter 2023

Insights+: The US FDA New Drug Approvals in July 2023

PharmaShots’ Key Highlights of First Quarter 2023

Insights+: EMA Marketing Authorization of New Drugs in January 2023

PharmaShots’ Most Read News of 2022

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