Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.

Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.

The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers.

Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.

Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.

Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.

Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.

Ipsen SA withdrew Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma.