If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.
Merck & Co. Inc. and Ridgeback Biotherapeutics Inc. are planning a U.S. emergency filing for potentially the first oral antiviral for COVID-19, after a phase III trial showed molnupiravir cut risk of hospitalization or death by around 50%.
The race to develop better antivirals for COVID-19 is heating up after Pfizer Inc. and Merck & Co. Inc. pushed ahead with clinical development of late-stage candidates, while Rigel Pharmaceuticals Inc. announced encouraging midstage data.
A team of researchers has created peptide-like molecules – "peptoids" – with antiviral properties that could circumvent the naturally occurring antimicrobial peptides' shortcomings.
PARIS – At some point, scientists reported, it may be possible to quarantine viruses rather than humans. For the last two years, European research consortium Virofight has been working on a form of nanotechnology intended to neutralize viruses such as SARS-CoV-2, HIV, influenza and hepatitis viruses.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
DUBLIN – Last May, a quartet of Dutch biotech industry veterans gathered for a socially distanced outdoor meeting in a private garden in Leiden to discuss what could be done to prevent the present COVID-19 fiasco from ever occurring on such a scale again. A new startup, Leyden Laboratories BV, emerged from that conversation, and it has just raised €40 million (US$47.3 million) in a series A round to develop broad-spectrum, self-administered, intranasal antiviral drugs to prevent infection.