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FDA Accepts NDA For Otsuka’s Novel Hyponatremia Treatment

FDA has accepted Otsuka’s new drug application for the investigational V2-vasopressin receptor antagonist tolvaptan, which could enter an increasingly crowded market.

Eisai Enters Agreement With Minophagen; Gains Asian Access to Liver Disease Products

Under the shadow of Eisai’s recent, massive “Dramatic Leap Plan” acquisitions, the company acquires the Asian development and marketing rights for Minophagen Pharmaceutical’s Stronger Neo-Minophagen C and Glycyron products.

Lundbeck/Takeda Advance Novel Anxiety Candidate To Phase III

H. Lundbeck and Takeda Pharmaceutical have initiated Phase III trials of their novel mood and anxiety disorders candidate Lu AA21004 roughly four months after inking a co-development deal, the firms announced Dec. 18.

Otsuka Bolsters Oncology Stable With IV Busulfex Acquisition

Otsuka looks to be strengthening its oncology business with the acquisition of PDL BioPharma’s IV Busulfex (busulfan), the company’s second cancer product acquisition of the year.

Takeda and GSK Challenge Latest Data Linking TZDs To Cardiovascular Events

Takeda and GlaxoSmithKline are disputing the findings of a Canadian study published in the December 12 issue of the Journal of the American Medical Association linking thiazolidinediones to cardiovascular events.

Astellas/Cardiome's Vernakalant Wins Advisory Committee Approval In 6-2 Vote

FDA's Cardiovascular and Renal Drugs Advisory Committee voted to approve Astellas Pharma/Cardiome's new drug application for its antiarrhythmic Kynapid (vernakalant hydrochloride injection) Dec. 11.

Eisai Strengthens Oncology Position With $3.9 Billion MGI Pharma Acquisition

In a move that will bolster its position in oncology, Eisai will buy MGI Pharma in an all-cash deal valued at $3.9 billion, the firms announced Dec. 10.

Astellas Advances Antibody R&D Agenda With Agensys Purchase Worth Up To $537 Million

Astellas has agreed to buy Agensys, a privately held U.S. biotech with a portfolio of novel cancer targets and monoclonal antibodies to match, in a deal worth up to $537 million, the firms announced Nov. 27.

Astellas, Daiichi Move Ahead With Factor Xa Programs

Astellas and Daiichi Sankyo both are on track to proceed to Phase III for their respective oral Factor Xa inhibitors, the companies indicated in second quarter earnings presentations on Nov. 7.