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Immuno-oncology and precision medicine will continue to lead emerging trends in the biopharmaceutical industry this year, the market research firm GlobalData reported. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Read More
Emergent Biosolutions has entered into an agreement to manufacture Humanigen’s lenzilumab, a potential treatment for COVID-19, ahead of an emergency use filing expected early this year. Read More
In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) piled onto the industry challenge to the federal 340B drug discount program, filing a complaint Friday in the U.S. District Court for the District of Maryland against a regulation promulgated by the Trump administration. Read More
In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Read More
Anthony Fauci, the leading U.S. authority on infectious diseases, has cautioned against putting off second doses of Pfizer/BioNTech’s and Moderna’s vaccines to accelerate initial vaccinations, a strategy the UK is currently using and one President Biden has said he will adopt as vaccine makers experience delays in vaccine shipments. Read More
President Biden yesterday revived a travel ban aimed at preventing the mutated strain of SARS-CoV-2 coronavirus first detected in South Africa from reaching the U.S. — and Moderna said it will launch a trial to evaluate a booster shot meant to provide additional protection against the mutated strain. Read More