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REGEN-COV is currently authorized to prevent COVID-19 infection in people 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease. Read More
The House Ways and Means Committee voted 24-19 yesterday to advance the Build Back Better Act with drug pricing reform provisions, shortly after the same reforms failed to make it into the House Energy & Commerce Committee’s version. Read More
The FDA’s vision of an enhanced drug distribution security program that would allow electronic tracing of every shipment is an impossibly complicated project that would take years to build, expose confidential company information and might even run afoul of federal law, said the Healthcare Distribution Alliance (HDA), the national organization that represents pharmaceutical distributors. Read More
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