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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
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
The company is currently seeking Emergency Use Authorization from the FDA and approval from Japan’s Pharmaceuticals and Medical Devices Agency for the test. 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
Pfizer and BioNTech released new study results yesterday indicating their COVID-19 vaccine would likely induce immunity for all 10 mutations on the spike protein of the SARS-CoV-2 viral strain identified in the UK, but other research suggests the vaccine might not be effective against new variants. Read More
Emeryville, Calif.-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger RNA technology designed to combat future variants of the coronavirus. Read More
Maryland’s state Senate has voted to overrule Gov. Larry Hogan’s veto of a bill to fund the state’s Prescription Drug Affordability Board (PDAB), an independent entity meant to cap prices for costly drugs in the state by 2022. Read More
The European Union (EU) and Canada will see temporary reductions in shipments of the Pfizer/BioNTech COVID-19 vaccine as Pfizer upgrades its Belgian facility to meet a goal of producing 2 billion doses annually, raising concerns as global coronavirus cases surge. Read More
Pennsylvania-based Jubilant Therapeutics and Philadelphia’s Wistar Institute are collaborating on a treatment that could tamp down the out-of-control immune reactions that occur in some COVID-19 patients. Read More
Sweden’s Cyxone has enrolled the first patient in a phase 2 trial of its investigational rheumatoid arthritis compound, rabeximod, in COVID-19 patients. The orally administered drug is intended to prevent disease progression in hospitalized COVID-19 patients by controlling hyperactivated immune cells in the lungs. Read More