Tag: Daiichi Sankyo

FDA Approved Daiichi Sankyo Enhertu

The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or met...

AZ and Daiichi Sankyo Presented “Clinically Meaningful” Responses to Trastuzumab Deruxtecan

AstraZeneca and Daiichi Sankyo have presented new mid-stage data showing “clinically meaningful” responses in patients with advanced breast cancer taking trastuzumab deruxtecan. The pivotal Phase I...

Daiichi Sankyo Started Legal Action against Seattle Genetics

Daiichi Sankyo has started legal action against Seattle Genetics. The case centers on linker technology used in antibody-drug conjugates (ADCs) including Daiichi’s AstraZeneca-partnered DS-8201. In...

FDA Granted Priority Review for Trastuzumab Deruxtecan

astrazeneca
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for trastuzum...

Astellas Agreed to Transfer Marketing Autorization for Three Products in Asia to Daiichi Sankyo

astellas
Astellas Pharma Inc. announced that subsidiaries of Astellas will transfer their marketing authorizations, trademark, and related contracts for “Nasea (5HT3 receptor antagonist-type antiemetic)”, “Per...

Daiichi Sankyo Announced Launch of VANFLYTA® in Japan

Daiichi Sankyo Company, Limited announced the launch of VANFLYTA® (quizartinib), an oral FLT3 inhibitor, in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid le...

Daiichi Sankyo Launched Oxycodone Extended Release Tablets NX “Daiichi Sankyo” in Japan

Daiichi Sankyo Company Limited announced it has launched a new generic formulation of oxycodone hydrochloride hydrate extended release tablets for sustained cancer pain treatment in Japan: Oxycodone E...

Daiichi Sankyo Announced Results from Edoxaban Plus P2Y12 Inhibitor Study

Daiichi Sankyo Company, Limited announced results from ENTRUST-AF PCI, the first large randomised study to evaluate the efficacy and safety of once-daily edoxaban (brand name as LIXIANA®) plus a P2Y12...

FDA Granted Approval to Daiichi Sankyo’s Turalio

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with seve...

Daiichi Sankyo Published Results of the Phase 3 Study of the Bempedoic Acid/Ezetimibe Combo

Daiichi Sankyo Europe GMbH announced that results from the 12-week, pivotal Phase 3 bempedoic acid / ezetimibe FDC tablet study (also known as Study 053) were published in the European Journal of Prev...

Rights for Four Diagnostic Imaging Agents to be Transferred from Daiichi Sankyo to GE Healthcare

GE-healthcare
Daiichi Sankyo Company, Limited and GE Healthcare have agreed that, Daiichi Sankyo will return the exclusive development and marketing rights in Japan for four approved diagnostic imaging agents to GE...

Daiichi Sankyo Looks to Sell its OTC Drug Unit

Japan’s Daiichi Sankyo Co Ltd is in talks with several companies to sell its wholly owned over-the-counter (OTC) drug unit, with the final price likely to reach around 100 billion yen ($900 million), ...

FDA Panel Voted on Daiichi’s Cancer Drugs

Daiichi Sankyo’s hope for a regulatory approval of its acute myeloid leukemia therapy quizartinib hit a snag after an advisory panel with the U.S. Food and Drug Administration (FDA) overwhelmingly vot...

AstraZeneca to Pay Daiichi-Sankyo $6.9 billion for Shared Rights to a New Cancer Drug

AstraZeneca Strikes $6.9 Billion Cancer Deal With Japanese Drugmaker. Deal for part of the rights to Daiichi Sankyo’s antibody drug is part of Astra’s heavy investment in cancer research. In a move...

First Drug for Rare Cancer under Priority Review

Daiichi Sankyo has been given a priority review from the FDA for pexidartinib, which is vying to become the first systemic drug therapy for rare cancer tenosynovial giant cell tumour (TGCT). The Ja...