Recon: FDA delays Novavax COVID vaccine approval; European drugmakers push for higher prices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
New England Journal of Medicine gets swept up in U.S. attorney inquiry into alleged bias (STAT)
NIH chief voices support for Nora Volkow, head of drug addiction research institute (STAT)
Roche seeks US tariff relief in direct talks with Trump administration (Reuters)
As FDA delays Novavax' COVID vaccine approval, patients fight back (Reuters)
Drugmakers brace for Trump tariffs with production shifts (Reuters)
What To Do When You Receive a DEA Order to Show Cause (FDA Law Blog)
US at tipping point for return of endemic measles (Reuters)
In Focus: International
Ireland’s Donohoe Says Watching US Companies for Reshoring (Endpoints)
Tariffs Won't Bring US Allies On Board Against China (Endpoints)
European pharma companies push for higher drug prices in EU amid US tariff threats (Reuters)
Semaglutide For MASH Among Raft Of New EU Filings (Pink Sheet)
Roche Q1 sales up 7% on drugs Phesgo, Vabysmo (Reuters)
Pharma & Biotech
Eli Lilly opens a new legal front in its battle against compounded GLP-1s (STAT)
Biotech is back, baby! It’s all upside from here (STAT)
Tariff questions swirl around pharma earnings (STAT)
Many young people want to quit vaping. A new study says medication can help (STAT)
Merck Faces Lawsuit to Block Launch of Easier-to-Use Keytruda (Bloomberg)
UPS Bolsters Health Unit With $1.6 Billion Deal for Andlauer (Bloomberg)
Novo Nordisk's stellar Wegovy-fuelled run of hiking sales guidance could be ending (Reuters)
Sanofi's quarterly profit boosted by Dupixent and newer drugs; forecast unchanged (Reuters)
Medtech
Danaher predicts $350M tariff hit, moves to mitigate impact on profits (MedTech Dive)
Boston Scientific is ‘very bullish’ on 2025 despite $200M tariff hit (MedTech Dive)
Intuitive lowers profit margin forecast due to tariff pressure (MedTech Dive)
Field Medical raises $40M for PFA in ventricular tachycardia (MedTech Dive)
‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’ (MedTech Insight)
Food & Nutrition
FDA asks food industry to phase out artificial dyes (Food Dive)
Food Industry Says There’s No Agreement With US Health Agency to Cut Dyes (Bloomberg)
Government, Regulatory & Legal
UnitedHealth discloses $1.7 million in security spending after slaying of top exec (STAT)
Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe (STAT)
As Republicans push work requirements in Medicaid, Arkansas offers a cautionary tale (STAT)
The volunteer committee advising on newborn screening must be reinstated (STAT)
Former Trump official warns president he’s at risk of ruining his legacy on ending HIV (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web.
Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.