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Over-the-counter drugmaker US Pharmaceuticals of Belleville, N.J. drew a Form 483 from the FDA with four observations following an Oct. 6-16, 2020 inspection. Read More
Merck said Tuesday its blockbuster cancer drug Keytruda (pembrolizumab) has received European Commission approval as a standalone therapy for two types of colorectal cancer. Read More
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