Recon: Roche eyes new trial for Elevidys in bid for EU approval; Biovac wins funding to build biggest vaccine site in Africa

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

In Focus: US

7 key issues we’re watching as RFK Jr. faces a Congressional gauntlet (STAT)
RFK Jr. Says Vaccine Might Have Saved Child Who Died of Measles (Bloomberg)
FDA panel will meet to discuss allowing broader access to certain peptides (STAT)
Hims Jumps as RFK Jr. Seeks to Loosen Peptide Regulations (Bloomberg)
US FDA weighs broader use of testosterone therapy for low sex drive in men (Reuters)

In Focus: International

Roche to launch another Elevidys trial, with eyes on European approval (STAT)
Biovac Wins EU, IFC Money to Build Biggest Africa Vaccine Plant (Bloomberg)
Sun Pharma, Grünenthal Are Said to Vie for US-Listed Organon (Bloomberg)
FDA Looks East—Here’s What Industry Needs to Know (FDA Law Blog)
Boston Scientific plans $88.5M R&D expansion in Ireland (MedTech Dive)

Pharma & Biotech

Novo Nordisk Has Hired 2,000 This Year to Reshape Workforce (Bloomberg)
Novo weight-loss drug may preserve lean body mass better than Lilly's, study finds (Reuters)
US FDA's accelerated approval for drugs needs more transparency, says research firm (Reuters)
New Bain biotech startup, building on BMS drugs, gets a name and a CEO (STAT)
Cochrane review dismissing amyloid drugs draws immediate backlash (Endpoints)
Using versus selling lucrative PRVs: Moderna's cautionary tale (Endpoints)
Lilly's obesity pill heads for diabetes filing after heart risk trial (Endpoints)
Women’s health biotech Freya Biosciences advances microbial therapy for IVF implantation failure (Endpoints)
Scribing startup Abridge adds NEJM, JAMA as it moves into medical AI search (Endpoints)
Abbott Cuts Profit Forecast in Wake of Cancer Screening Deal (Bloomberg)

Medtech

CMS proposes rolling back breakthrough device payment flexibilities (STAT)
Toxic Gas-Emitting Plants Get Pollution Reprieve Under Trump (Bloomberg)
Medtronic confirms paclitaxel balloon’s efficacy in post-approval trial (MedTech Dive)
AIP to acquire Avanos Medical in $1.27B go-private deal (MedTech Dive)
Stereotaxis to buy Robocath for up to $45M (MedTech Dive)
Osteoboost Raises $8M To Scale FDA-Cleared Vibration Device For Osteopenia (MedTech Insight)
Cardiovascular Leads J&J Medtech’s Q1 As Abiomed And Shockwave Deliver Double-Digit Growth (MedTech Insight)

Food & Nutrition

UK Prepares for Food Shortages Caused by Iran War CO2 Crunch (Bloomberg)
Indonesia orders food companies to apply colour-graded sugar, fat content stickers (Reuters)

Government, Regulatory & Legal

For Ben Sasse, Revolution Medicines’ pancreatic cancer trial felt like his best, only option (STAT)
The medical AI revolution requires rethinking health care’s architecture (STAT)
AI could check millions of CT scans for heart risk. Who will pay for it? (STAT)
Wonky US Health Policy Communications Creates Investor Opportunities (Bloomberg)
CBP preps tariff refund portal for April 20 launch (MedTech Dive)

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.