The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
Barinthus Biotherapeutics plc’s immunotherapeutic against persistent, high-risk human papillomavirus (HPV) infections, VTP-200, was generally well-tolerated in a phase Ib/II study, but did not demonstrate significant signs of efficacy, pooled top-line data show.
Corner Therapeutics Inc. raised $54 million in a series A financing to create vaccines to protect against cancer and infectious diseases by helping the immune system engineer T cells. The company’s core interest is in advancements in immunotherapy through direct manipulation of T cells, which are the “keys to the kingdom for any cancer therapy,” Nick Seaver, Corner’s chief business officer, told BioWorld.
YS Biopharma Co. Ltd. has received clinical trial approval by the Philippine Food and Drug Administration to begin a phase I trial of its YS-HBV-002 immunotherapeutic vaccine, designed to treat chronic hepatitis B virus (HBV) infection. The trial will begin in the Philippines in June.
Spikimm SAS has signed an exclusive collaboration and license option agreement with SATT Conectus Alsace SAS for monoclonal antibodies targeting the BK virus. Reactivation of the BK virus (BKV) in patients receiving kidney transplant, bone marrow or stem cell grafts has potential serious consequences.
South Korea’s Eubiologics Co. Ltd. said it gained the World Health Organization’s (WHO) prequalification designation on April 16 for its simplified oral cholera vaccine, approved as Euvichol-S.
The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Marvax, a heat stable subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.
Vaccination with infectious Plasmodium falciparum sporozoites (PfSPZ) administered with antimalarial drugs (PfSPZ-CVac) is more effective than vaccination with replication-deficient, radiation-attenuated PfSPZ. However, the requirement for drug administration is a significant limitation of the PfSPZ-CVac strategy.
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