Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Axsome, George Medicines, Italfarmaco, Lipocine, Tuhura, Verity.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beone, Compedica, Concentra, Elevation, Formosa, Harrow, Neowise, Nipro, Portage, Samsung Bioepis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Avidity, Everest, In8bio, Merck, Metsera, Newamsterdam, Polypid, Regeneron, Sanofi, Vertex.
Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East.
Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions to analyze the microbiome differences and their effects after transplantation form different intestine areas. The results show how host-microbe mismatches after these interventions could affect gut health.
Insmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 28.7% June 10.
Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting.
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