FDA

The U.S. drug regulator on June 29 declined to approve MediWound Ltd.’s topical burn treatment NexoBrid, sending the company’s shares tumbling in trading.

Eric Lander, founding director of the Broad Institute of MIT and Harvard and science adviser for the White House, said in an interview that he wants to have an available vaccine that can fight the next pandemic in about 100 days after recognizing the initial outbreak.

Moderna Inc. said on April 28 the U.S. government had agreed to increase the contract for the company’s Covid-19 vaccine by $236 million to roughly $1.25 billion, to include additional costs related to the shot’s studies.

Emergent BioSolutions’ Phase III trial of SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) to treat hospitalized patients with COVID-19 showed that the addition of the treatment to Gilead Sciences’ remdesivir did not provide clinical benefit compared to standard of care plus placebo in hospitalized adult COVID-19 patients with symptoms for less than 12 days.

AstraZeneca released primary analysis showing that the company’s AZD1222 vaccine demonstrated 76 percent efficacy against symptomatic Covid-19, 100 percent efficacy against severe or critical disease and hospitalizations, and 85 percent efficacy against symptomatic Covid-19 in people 65 years and older.

Merck logo

Merck entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/Covid-19 medicines and vaccines.

Novavax

Drug developer Novavax Inc. completed enrolling 30,000 volunteers in a late-stage study of the company’s Covid-19 vaccine in the United States and Mexico.

Johnson & Johnson secured more than $1 billion in additional funding for the company’s Covid-19 vaccine research through an expansion of J&J’s partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.

Johnson & Johnson and the U.S. Department of Health and Human Services expanded an agreement to support the next phase of Covid-19 vaccine candidate research and development, the company said.

President-elect Joe Biden hit the ground running with the announcement of his transition team’s Covid-19 advisory board that will be co-chaired by public health experts and includes Rick Bright, a vaccine expert and the former director of the Biomedical Advanced Research and Development Authority (BARDA), who raised concern about President Trump’s response to the pandemic in April.