Apogee Therapeutics Inc. loaded up on what could total as much as $1.3 billion in financial fuel from Blackstone Life Sciences funds that will be used to propel zumilokibart (zumi), which yielded positive phase II results in atopic dermatitis (AD). A phase III experiment with the anti-IL-13 antibody is planned for the second half of this year, pending talks with regulators.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbvie, Agios, Astellas, Astrazeneca, Boehringer, Daiichi, Gilead, Merck, Novo, Regeneron, Teva.
Acknowledging that the spread of the Andes virus and the resulting disease, hantavirus pulmonary syndrome, “constitutes a credible risk of a future public health emergency,” U.S. Health and Human Services Secretary Robert Kennedy is issuing a declaration to provide liability protection for manufacturers, distributors and providers using favipiravir as a medical countermeasure (MCM) against the virus.
What would normally be a routine meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee May 28 may be more carefully watched given the overall turmoil surrounding vaccines in the U.S. The only task before the adcom is to recommend the COVID-19 vaccine formula for the upcoming season. That conversation will include looking at the effectiveness of the four FDA-approved vaccines currently in use in the U.S.
Upbeat phase II news lately from Spyre Therapeutics Inc. in inflammatory bowel disease (IBD) perked not only the company’s stock but also wider interest in the buzzing space, where developers big and small are trying to tackle such chronic bedevilments as Crohn’s disease and ulcerative colitis (UC).
Less than two weeks after the outbreak was officially declared, animal studies of a newly designed vaccine against the Bundibugyo Ebola virus are now underway in the U.S. and U.K., and the Serum Institute of India is standing ready to manufacture the vaccine for clinical trials. If the animal tests are positive, the vaccine will be ready for clinical trials in two to three months.
Medtronic plc is strengthening its pain management portfolio with its $650 million move to buy SPR Therapeutics Inc. and bring the company’s peripheral nerve stimulation system for sustained pain relief into its neuromodulation offering. The deal marks Medtronic’s third tuck-in deal so far this year, following its $585 million purchase of Cathworks Ltd. and $550 million acquisition of Scientia Vascular Inc., and is also a sign of the momentum in M&A activity in the medtech sector with other players making strategic acquisitions.
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