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Despite a recent warning from HHS that drugmakers could face fines if they continue to hold back 340B drug discounts from clinics and hospitals serving low-income patients, Eli Lilly and AstraZeneca (AZ) appear determined to resist, filing motions in federal court against the department’s June 1 deadline. Read More
Only 23 Republicans voted against the bill Wednesday, a dramatic change from the 250 to 168 floor vote last week when a two-thirds majority was required. Read More
The application is supported mainly by positive phase 3 trial findings and the agency has set a target decision date for the drug in March 2022. Read More
A generic synthetic peptide must not contain a new peptide-related impurity that is more than 0.5 percent of the drug substance, the agency said. Read More
Eli Lilly said its experimental drug, tirzepatide, reduced blood glucose levels and body weight in type 2 diabetics with increased risk of heart disease more effectively than Sanofi’s blockbuster diabetes drug Lantus (insulin glargine) in a head-to-head phase 3 study. Read More
The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
Sandoz has run out of legal recourse and will have to wait for the Enbrel patents to expire before it can launch biosimilar Erelzi, which has been FDA-approved since August 2016. Read More
G20 leaders are expected to call for patent-pooling whereby drugmakers will share patents voluntarily, allowing developing nations to manufacture COVID-19 products. Read More
The FDA clarified in a new guidance released yesterday when it is appropriate for drug sponsors to submit an abbreviated new drug application (ANDA) for a synthetic peptide drug product that references an already approved synthetic peptide of recombinant DNA origin. Read More