Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220.
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
Antibody-drug conjugates are the hot spot for deals in Asia, but investors questioned whether oncology is really the place to be, during the Asia Bio Partnering Forum in Singapore April 24 to 25.
X4 Pharmaceuticals Inc. is raring to go with marketing after the firm scored U.S. FDA approval of Xolremdi (mavorixafor) capsules for patients 12 years and older with warts, hypogammaglobulinemia, infections and myelokathexis, or WHIM syndrome, to increase the number of circulating mature neutrophils and lymphocytes.
The government of Colombia, after signaling its intent to do so at the end of 2023, issued a compulsory license on April 24 for access to generic versions of HIV drug dolutegravir, without the permission of patent owner Viiv Healthcare Ltd.
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.
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.
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