Following the advice of a panel of outside experts, the FDA has turned down a potential Covid-19 drug that only had data from a small trial.

Miami, FL-based Veru had repurposed a microtubule disruptor called sabizabulin, which it had been testing in cancer, to treat hospitalized adult patients with moderate to severe Covid-19 who are at high risk for ARDS, or acute respiratory distress syndrome.

CEO Mitchell Steiner suggested that the FDA rejected the drug “because of the possibility of unknown influences, or uncertainties that may have affected the study.” The company noted that the agency offered comments for a proposed confirmatory Phase III.

European regulators recommended the EMA reject Merck’s Covid antiviral, saying that there’s not enough evidence it works in patients.

Merck and partner Ridgeback Biotherapeutics announced the CHMP’s decision on Friday.

The committee refused to recommend the approval of Lagevrio, also known as molnupiravir, by initially stating that the review has been ongoing for more than a year. The committee had supported decisions from member states starting in November 2021, if they wanted to consider early use of molnupiravir before any potential approval.

Pfizer and BioNTech are seeking full approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.

The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.

Merck took another swing at bat to bolster its case for its Covid-19 antiviral — and that swing turned into yet another miss.

The pharma giant said Tuesday morning that its antiviral molnupiravir, branded as Lagevrio, failed to show “a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19” in a Phase III trial.

The study enrolled more than 1,500 participants — all who lived with someone who was newly diagnosed with Covid-19. That household member was also showing at least one symptom or sign of the disease, and had not had said symptoms for more than five days.

Moderna said Wednesday that people won’t need to pay out-of-pocket for its Covid vaccine, regardless of their insurance status, once the US government stops covering the cost of the shots.

Last week, the Department of Health and Human Services confirmed plans to on May 11 end the federal Covid-19 public health emergency. Since Congress hasn’t signed off on additional funds for vaccines and treatments, the government will halt its free shot provision this year.

Novavax will still be manufacturing Covid vaccine doses for the US government.

On Monday, the Maryland-based vaccine maker announced that, in collaboration with HHS and DoD, it plans to deliver up to 1.5 million doses of its Covid-19 vaccine. The agreement will allow for access to Novavax’s Covid vaccine and help with developing other dosages for different strains of the virus, according to a release from Novavax.

UK-based biotech Scancell is lifting the veil off a Phase I trial for its Covid-19 vaccine, but it’ll also be making a pivot on the vaccine’s strategy.

Scancell said in a release on Monday that it is presenting the preliminary data from its Phase I clinical trial, which was conducted at the University of Cape Town Lung Institue in South Africa. The trial was intended to look at two of vaccine Scancell’s candidates, SCOV1 and SCOV2, in patients before testing them as a booster. According to the biotech, both candidates are plasmid DNA-based vaccines.

Daiichi Sankyo is looking to establish a manufacturing apparatus close to home to begin producing the first made-in-Japan mRNA Covid vaccines.

According to a report from Nikkei Asia, Daiichi Sankyo is installing equipment that will have the capacity to produce 20 million doses a year by the fiscal year 2024. The report says that equipment has been installed at a location in the city of Kitamoto, Japan, northeast of Tokyo, and is operated by the subsidiary Daiichi Sankyo Biotech.