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The House Energy and Commerce Committee is marking up a massive $3.5 trillion infrastructure spending package this week that includes provisions aimed at reducing the price of prescription drugs. Read More
COVID-19 vaccine booster shots may be necessary to sustain waning immunity, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks in remarks at the RAPS Convergence annual conference, which is being held virtually this week because of the pandemic. Read More
Gaithersburg, Md.-based Emergent BioSolutions has struck a five-year deal with Providence Therapeutics to help manufacture the Canadian company’s COVID-19 vaccine candidate. Read More
The doctor submitted the results to ClinicalTrials.gov one day after receiving the warning letter, sidestepping a potential fine of at least $10,000 for every day he was in noncompliance. Read More
A federal judge has denied Teva Pharmaceuticals’ motion to dismiss a lawsuit alleging the Israeli drugmaker paid kickbacks to charitable foundations to subsidize Medicare patients’ out-of-pocket payments for its multiple sclerosis drug Copaxone (glatiramer). Read More
A third of the indications for cancer drugs that failed their confirmatory trials after accelerated approval remain on the label for years, with some even getting high endorsements from an alliance of 31 leading oncology centers. Read More
Acting FDA Commissioner Janet Woodcock has sent a letter to the U.S. Patent and Trademark Office (PTO), asking the office to investigate drugmakers’ use of “patent thickets” and other anticompetitive patent practices. Read More
Two outgoing vaccine experts at the FDA as well as experts from the World Health Organization (WHO) are arguing that providing COVID-19 booster shots to the general public isn’t warranted at this time. Read More