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The FDA has indicated that it will be asking Pfizer-BioNTech to perform more studies on the COVID-19 vaccine Comirnaty’s booster shot before approving the companies’ supplemental biologics license application (BLA). Read More
Following encouraging talks with the FDA in July, Amylyx Pharmaceuticals plans to submit a new drug application (NDA) for AMX0035, a compound designed to slow neurodegeneration in amylotropic lateral sclerosis (ALS) patients. Read More
The FDA and the European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice to applicants seeking marketing authorization from the EMA for hybrid products and for those filing abbreviated new drug applications (ANDAs) with the FDA for complex generic drugs. Read More
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