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The Institute for Clinical and Economic Review (ICER) issued its final word on two treatments for the autoimmune disease Myasthenia Gravis (MG), saying both are useful medically but need colossal price reductions in order to make them at all affordable. Read More
The House of Representatives passed a bill in a bipartisan 368-56 vote late Tuesday that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process. Read More
In the last 10 months, the FDA evaluated drugs on the market for 10 cancer indications after having granted them accelerated approval (AA) based on surrogate endpoints, and eventually found that the drugs had a confirmed lack of benefit in several indications — but not before Medicare spent $224 million on them from 2017 to 2019. Read More
The FDA is poised to authorize booster shots of Moderna’s and Johnson & Johnson’s COVID-19 vaccines and may also allow a “mix and match” approach. Read More
Lawsuits seeking to force hospitals to administer ivermectin to COVID-19 patients show no signs of slowing in recent weeks — despite repeated warnings by regulators against such use. Read More
Any changes made in a unit operation of continuous manufacturing may have a direct and often immediate impact on downstream and upstream operations, the agency said. Read More
The European Medicines Agency’s (EMA) expert panel on human medicines has recommended approval for Gilead Sciences’ novel therapy for an aggressive form of breast cancer and for five other drugs. Read More
A federal judge has denied a motion from the Department of Justice (DOJ), seeking to stop the disbursement of $10 billion of Purdue Pharma opioids settlement money while the appeals process is ongoing. Read More
Molnupiravir, the controversial COVID-19 oral antiviral made by Merck and subsidiary Ridgeback Therapeutics, will have its day in committee, the FDA has announced. Read More
A day after its unanimous vote in favor of Moderna’s COVID-19 booster shot, a panel of vaccine experts that advises the FDA also voted unanimously to grant Johnson & Johnson’s (J&J) COVID-19 booster shot Emergency Use Authorization (EUA). Read More
An additional dose of the same vaccine as the primary series boosted antibody levels four- to 20-fold, while mixing and matching primary vaccines and booster doses boosted antibody levels six- to 76-fold. Read More