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Eli Lilly has announced that it will drop the list price of its Insulin Lispro Injection by 40 percent in the U.S. as of Jan. 1, bringing the drug’s list price down to 2008 levels. Read More
Acting FDA Commissioner Janet Woodcock outlined the FDA’s proposed commitments to industry under the next iteration of the Prescription Drug User Fee Act (PDUFA) — and pledged to support enhanced reviews of emerging biotherapeutics — during a virtual public meeting held yesterday. Read More
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has let his staff know that he is now also acting director of the agency’s Office of Vaccines Research and Review (OVRR) as its two top officials prepare to retire this fall. Read More
Under the 340B program, pharmaceutical manufacturers extend lower pricing to hospitals and clinics that treat significant numbers of low-income patients. Read More
The risks have been well-known for years, but the Department of Defense has neither assessed them nor solved any of the problems they present, the document notes. Read More
The FDA would like to know more about whether drug shortages are happening at the point of manufacture or downstream in the supply chain, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni said in remarks yesterday at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More
Novo Nordisk has agreed to a $100 million settlement in a 2017 class action lawsuit that accused the company of making kickbacks to pharmacy benefit managers (PBMs) and failing to disclose information about its revenues related to insulin. Read More
HHS has issued an updated contingency plan in case government funding runs out this week, covering FDA operations in case Congress fails to pass a stopgap measure funding the federal government from Oct. 1 through Dec. 3. Read More
Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), on Friday defended overriding the CDC’s own advisory panel, which voted the previous day not to recommend a Pfizer COVID-19 booster shot for people at high risk of contracting the disease in the workplace. Read More