While biopharmaceutical research is currently concentrating on the threat posed by the COVID-19 pandemic, the disease has provided a sharp reminder that our focus should not be lost on infectious diseases as a whole, along with the growing global problem of antibiotic resistance (AMR), which has the potential to dwarf COVID-19 in terms of deaths and economic costs, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Two weeks after receiving a letter from the FDA citing deficiencies in the NDA seeking approval for VP-102 (cantharidin 0.7% topical solution) in molluscum contagiosum, Verrica Pharmaceuticals Inc. disclosed an unsurprising complete response letter.
LONDON – Twenty-three pharma companies are joining forces in the AMR Action Fund and have raised $1 billion in new money for the clinical development of antibiotic drugs addressing the most resistant bacteria. Working with philanthropic backers, the fund aims to bring two to four new antibiotics through to approval by 2030.
DUBLIN – Osivax SAS has assembled a public funding package of more than €32 million (US$36.3 million) to pursue ongoing clinical development of its universal flu vaccine and to take forward a coronavirus vaccine program based on a similar approach, involving vaccine-like particle (VLP) technology.
Forty years after HIV became a global pandemic, there are now more than 30 drugs approved to treat it. The National Institute of Allergy and Infectious Diseases’ director, Anthony Fauci, and clinical director, Clifford Lane, opined in the July 2, 2020, issue of The New England Journal of Medicine that “considering the spectacular scientific advances that have been made over nearly four decades, it is conceivable that with optimal implementation of available prevention strategies and treatments, the end of HIV/AIDS as a global pandemic will be attainable.”
The checkpoint molecule CD47 has high hopes riding on it in oncology as being the innate immune equivalent of PD-1. Multiple companies are developing blockers against CD47 and/or its ligand, SIRPa, for the treatment of various tumors.
DUBLIN – Top-line data from a phase II pivotal trial of CP-101, Finch Therapeutics Group Inc.’s oral microbiome therapy for chronic Clostridioides difficile infection (CDI), are technically good, but how good is the big question.
A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
BEIJING – Three-year-old Asia-focused startup Everest Medicines Ltd. closed one of the biggest financing rounds in China’s health care market this year, adding $310 million to its war chest. The firm is aiming to advance its late-stage assets in-licensed from global partners to the China market soon.
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