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Eli Lilly has agreed to pay Dutch drugmaker Merus up to $1.6 billion to develop novel T-cell re-directing bispecific antibodies for treating various cancers. Read More
Italy is taking legal action against Pfizer for delays in supplying vaccine doses, contending the company is not honoring its supply contract and putting the country’s inoculation campaign at risk. Read More
The Biden administration is facing a tall order to meet its goal of vaccinating 100 million Americans in its first 100 days, given the weaknesses and ongoing delays in the country’s decentralized distribution and vaccination process. Read More
Janet Woodcock stepped into her new role as acting FDA Commissioner this week, pledging in an email to agency staff to maintain the agency’s science-based approach. “The American people can be certain that science — above all — will continue to guide the FDA’s regulatory actions now and into the future,” she said. Read More
Eli Lilly reported yesterday that its monoclonal antibody bamlanivimab (LY-CoV555) significantly lessened the risk of contracting COVID-19 among nursing home residents and staff, according to findings from a phase 3 trial. Read More
Merck announced that it is ending a phase 3 study evaluating its immunotherapy bintrafusp alfa in patients with stage IV non-small-cell lung cancer, following disappointing efficacy results. Read More
The FDA is calling for risk assessments by cell and gene therapy (CGT) manufacturers to minimize the potential for transmitting the SARS-CoV-2 virus through their products, according to a new straight-to-final guidance released yesterday. Read More
Under the Biden administration, the U.S. will join the World Health Organization (WHO)’s COVAX program and may potentially contribute billions of dollars toward providing access to COVID-19 vaccines in low- and middle-income nations, though it’s not yet known how much money the president will pledge. Read More