Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.
Freed from the burden of paper reviews, the US Food and Drug Administration is plotting an escape from legacy free text that burdens electronic reviews with drug quality narratives.
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An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Scrip about the latest developments.
The big pharma forecast a $400m expense this year related to tariffs, but those estimates only reflect medtech tariffs already announced, not potential pharma tariffs.
India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.
The Swiss major follows Lilly and J&J in committing to a significant spend on US manufacturing.
In this week's episode: Trump’s drug pricing executive order; J&J says taxes, not tariffs, influence US manufacturing; Pfizer discontinuation sparks M&A speculation; US tariffs and manufacturing concentration; and tariffs’ pressures on pharma’s complex supply chain.
Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.
Cancer assets drove the highest percentage of biopharma alliance dealmaking in 2024, tripling the frequency of the next highest therapeutic category, neurology.
