Recon: Bayer plans for $2.2B manufacturing site in Ohio; FDA’s CDER launches clinical trial modernization office

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• FDA seeks public input to support ibogaine research (FDA)
• Transparency makes modern regulatory science stronger - FDA’s transparency roadmap (FDA)
• FDA launches new clinical trial modernization office within CDER (Endpoints)
• FDA approves expanded use of BMS’ Camzyos (The Pharma Letter)
• With FDA approval, Lilly’s BTK drug Jaypirca enters first-line CLL (Fierce Pharma) (Lilly)
• FDA extends review of Novo Nordisk's hemophilia drug over facility issues (Reuters)
• FDA principal deputy COO Melissa Shea departs for NIH (Medtech Insight)
• FDA must ensure American patients can access new and experimental drugs (BioSpace)

In Focus: International

• EU JCAs: New patient templates mark progress, but earlier involvement remains critical (Pink Sheet)
• Dozens quarantined in Siberia after plague institute lab worker dies (Reuters)
• Hansoh plans new EU filing after Aumseqa approval revoked (The Pharma Letter)
• Rebel-held eastern Congo records six new Ebola cases (Reuters)

Pharma & Biotech

• Bayer unpacks plans for $2.2B manufacturing site in Ohio (Endpoints) (Fierce Pharma)
• Novartis pens $7.8B deal for Abogen's in vivo autoimmune T-cell engager (Fierce Biotech)
• Nobel goes to scientists who paved the way for light-activated gene therapies (Endpoints) (STAT)
• Alector soars as Roche licenses Parkinson's therapy for up to $1.27 billion (Reuters)
• Novartis takes rights to Abogen's mRNA T cell engager for $575M upfront (Endpoints)
• CSL to pay $355M upfront to co-develop Alentis’ kidney and liver drug (Endpoints) (Fierce Biotech)
• Pfizer’s Litfulo significantly improved skin pigment measures (The Pharma Letter)
• Biogen's experimental lupus drug shows benefit against skin symptoms (Reuters)
• Regeneron's antibody helps patients regain muscle after stopping GLP-1 therapy (Endpoints)
• Lilly pulls back from Foghorn's synthetic lethality work as biotech sheds 40% of staff (Endpoints)
• Geographic atrophy biotech Aviceda to shut down after phase 2 fail (Endpoints)

Medtech

• Big win for small patients: FDA approves first pediatric heart valve that expands with growth (Medtech Insight) (MedTech Dive)
• Medtronic drug-coated balloon gets FDA breakthrough status (MedTech Dive)
• FDA selects first 5 participants for READI-Home initiative (MedTech Dive) (MedTech Insight)
• Independent review finds FDA met MDUFA V commitments, as PCCP authorizations triple (Medtech Insight)
• Medtronic reveals cardiac mapping and ablation software clearances (MedTech Dive)
• GE HealthCare to buy Sofie for nearly $1 billion to grow medical-imaging business (Wall Street Journal)
• Boyu said to weigh sale of contract medical device maker Quasar (Bloomberg)

Food & Nutrition

• FDA found Cyclospora during Taylor Farms inspection in Mexico (New York Times) (AP News)
• EU-funded project to develop novel technologies for continuous microbial monitoring in poultry supply chain (Food Safety Magazine)
• UK publishes guidance for cell-based food producers on regulatory authorization, growth media safety (Food Safety Magazine)
• Energy drinks’ new college sports partnerships make them more dangerous than ever (STAT)

Government & Legal

• AbbVie joins US government pilot to test drug discount rebates (Reuters)
• Trump announces $90 payments for seniors’ Medicare premium costs ahead of midterm elections (STAT)
• The law has to catch up on orphan-designated drugs with multiple uses (STAT)
• Another win for HCT/P manufacturers: Court vacates and remands FDA’s AXIOFILL determination (FDA Law Blog)
• As CDC redesigns annual health survey, it removes questions about disabilities (STAT)
• NIH awarded all its grant funding, but delayed and opaque decisions stymied researchers (STAT)
• Medicare Advantage plans shift more costs onto seniors in 2027 (STAT)
• Vance's fraud crackdown may raise costs for US health insurers, enrollees (Reuters)
• NIH rolling out streamlined website to help public find information more easily (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.