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The new plant is projected to reduce time to drug commercialization, lower costs and enable more sustainable manufacturing processes, said the Anglo-Swedish drugmaker. Read More
The FDA is responding to frequently asked questions from generic drugmakers — including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday. Read More
Nearly a dozen bipartisan lawmakers have sent a letter to the U.S. Patent and Trademark Office (PTO), arguing that it has enabled drugmakers to block competition by weakening a system Congress put in place for challenging patent abuses. Read More
The FDA’s drug approval decisions are made in a siloed, ad hoc manner, rather than using institutional knowledge of similar decisions that went before at the agency. And often, the judgments FDA officials make about the research before them on drug candidates are too subjective. Read More
Johnson & Johnson (J&J) is poised to be the next company to jockey for approval for its COVID-19 vaccine booster, just days after FDA’s vaccine experts voted no on Pfizer-BioNTech’s booster for the general population. Read More
In another potential obstacle to the Democrats’ drug pricing reform efforts, Sen. Kyrsten Sinema (D-Ariz.) may not support legislation being considered in both the Senate and House for possible inclusion in a $3.5 trillion spending package. Read More
The UK’s Health Research Authority (HRA) has put trial results reporting in its crosshairs after prompting from UK lawmakers, making it clear that it expects researchers to explain how they met their transparency obligations at the end of their trials. Read More
Boehringer Ingelheim (BI) has joined others calling on the FDA to modify some details of its proposed enhanced electronic drug distribution security program. Read More
An FDA advisory panel declined Friday to recommend approval of a Pfizer/BioNTech COVID-19 vaccine booster for the general population but it voted unanimously, 18-0, to grant an updated Emergency Use Authorization (EUA) covering boosters in people 65 years and older as well as those at high-risk of progressing to severe disease. Read More