Recon: FDA reject’s Cingulate’s ADHD drug over manufacturing issues; Travere licenses Everest kidney disease drug for up to $1.14B

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

In Focus: US

Eli Lilly warns hospitals to submit claims data in the next five days or lose their 340B drug discounts (STAT)
Travere licenses Everest's kidney disease drug in deal worth up to $1.14 billion (Reuters) (Endpoints)
Fulcrum plummets over 50% after scrapping lead sickle-cell drug on FDA concerns (Reuters)
Trump administration releases rules for new Medicaid work requirements (STAT)
FDA declines to approve Cingulate's ADHD treatment over manufacturing issues (Reuters)
Health officials oppose US plan to treat Ebola-exposed Americans overseas (Reuters)
Trump’s New Vaccine EO Could Signal ACIP Emerging From Legal Issues (Pink Sheet)

In Focus: International

WHO says suspected Ebola cases drop to 116 after hundreds ruled out (Reuters)
Congo re-opens airport at centre of Ebola outbreak (Reuters)
Global Biotech Giants Deepen Ties with China’s Drugmakers (Bloomberg)
Biosimilar Drugs: Canada Drops Need For Comparative Clinical Efficacy Studies (Pink Sheet)

Pharma & Biotech

Abivax ulcerative colitis drug shows strong efficacy, but cases of cancer raise concerns (STAT)
At the world’s largest cancer research meeting, data briefly took a backseat to grief (STAT)
Allen Institute launches $200M effort to turn brain atlas lessons into medicines (Endpoints)
Celcuity aims for broad FDA approval after positive breast cancer readout (Endpoints)
Legend Biotech shares first in vivo CAR-T data, its next act after Carvykti (Endpoints)
Roche details narrow failure of breast cancer pill trial (Endpoints)
Legend's experimental cell therapy shows promise in blood cancer patients (Reuters)
Contraline and its male birth control candidate rally $92.5M amid push into 'massive white space' of men's health (Fierce Pharma)
Gilead's Livdelzi scores in rare liver disease trial, portending use in broader patient population (Fierce Pharma)

Medtech

China’s BrainCo Sees Bionic Hand Sales Boom From Robot Makers (Bloomberg)
Resmed completes $340M Noctrix takeover (MedTech Dive)
Intuitive elevates Taylor Patton to chief commercial and marketing officer (MedTech Dive)
GRAIL’s Galleri Cleared Secondary Bars At ASCO, But Primary Endpoint Miss Remains (MedTech Insight)
Child Death Overseas Prompts KayserBetten To Replace Hand Controls On Pediatric Care Beds In US (MedTech Insight)

Food & Nutrition

China recognises Brazil as foot-and-mouth disease free, lifts bans (Reuters)
Eisai whips up Alzheimer’s dietary guidance to expand nutrition program beyond cancer (Fierce Pharmsa)

Government, Regulatory & Legal

Exclusive: Bipartisan group of lawmakers unveil new bill to restrict China biotech (Endpoints)
Online care is caught in the crossfire as states crack down on corporate medicine (STAT)
As FDA misses deadline on electric shock ban, disability advocates speak out (STAT)
Swiss Dental Startup vVardis Is Preparing for US IPO (Bloomberg)
CNPV Public Meeting Questions: US FDA Seeks Talking Points Before Confirming Speakers (Pink Sheet)

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.