Recon: Merck KGaA to buy SpringWorks for over $3B; US tariffs could increase drug spending by $51B per year
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
U.S. health officials inject new uncertainty into approval process for Covid boosters (STAT)
Our 7 biggest questions as Congress returns to work (STAT)
Exclusive: US pharma tariffs would raise US drug costs by $51 billion annually, report finds (Reuters)
Merck KGaA to purchase SpringWorks Therapeutics in deal worth more than $3 billion (STAT) (Reuters)
Novavax responds to FDA’s trial ask, with Covid vaccine strain updates under scrutiny (Endpoints)
Not so fast on the FDA’s food dye ban — the Supreme Court has changed the rules (The Hill)
FDA commissioner says ‘no plans’ to pull abortion pill mifepristone (Semafor)
In Focus: International
Akeso wins Chinese approval for cancer drug positioned to rival Merck’s Keytruda (STAT)
Novo Nordisk's obesity drug Wegovy debuts in Thailand (Reuters)
Sandoz CEO slams EU-wide drug price proposal, warns US tariffs will hurt patient access (Reuters)
Singapore negotiating for US concessions on pharmaceuticals, chips (Reuters)
France stops Valneva's chikungunya vaccine rollout in over 65s after safety issue (Endpoints)
European regulators recommend new drugs from Vertex, Amgen and Jazz (Endpoints)
Lilly requests EMA to re-examine Alzheimer's drug recommendation (Reuters)
Pharma & Biotech
Major tuberculosis vaccine trial completes enrollment faster than expected (STAT)
Boehringer’s updated results in HER2-mutated lung cancer impress (Endpoints)
Revolution Medicines' KRAS drug shows potential in early cut of lung cancer data (Endpoints)
Daiichi Sankyo says production boost in US will help cushion tariff impact (Endpoints)
GSK’s checkpoint blocker Jemperli cures biomarker-driven rectal cancer (Endpoints)
Keytruda around head and neck cancer surgery cuts chance of disease coming back (Endpoints)
J&J reports durability data for bladder cancer 'pretzel' drug after FDA filing (Endpoints)
Medtech
Tariffs are hitting surgical robots and pacemakers, but device companies aren’t sweating it, yet (STAT)
Revvity beats quarterly estimates on steady demand for medical equipment (Reuters)
Exclusive: Can AI replace animal testing? A new biotech launches to find out (MedTech Dive)
Boston Scientific CFO Dan Brennan to retire after nearly 30 years with the company (MedTech Dive)
Michael Greiner leaves Avanos over offer under new CEO (MedTech Dive)
‘AI Isn’t Flying Off The Shelves In The NHS,’ Says Healthtech Startup CEO (MedTech Insight)
Food & Nutrition
The latest tariff challenge for businesses? Setting prices. (Food Dive)
Meat giant JBS gets SEC approval to list shares in US (Food Dive)
PepsiCo CEO says snacks maker ‘accelerating’ transition to natural ingredients (Food Dive)
USDA Finds Meat, Poultry, Farmed Catfish are PFAS-Free; but Detects PFAS in Half of Wild Catfish (Food Safety)
Government, Regulatory & Legal
UnitedHealth discloses $1.7 million in security spending after slaying of top exec (STAT)
‘Fight for your science’: Researchers urged to speak out at AACR (STAT)
Rural health study is told it’s losing federal funds, and other major heart studies are worried (STAT)
NIH announces six new acting institute directors, many of them filling posts of ousted predecessors (STAT)
HRS Released Framework For Afib Center Of Excellence To Improve Outcomes Through Multidisciplinary Care (MedTech Insight)
Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation (MedTech Insight)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.