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For the week of:

March 2, 2026

Global experiments in rare disease innovation

Overlaps, differences in approaches in Australia, China, India, Korea, the U.K. and the U.S.

Regulation

Rare disease spotlight: Stargardt’s first approval in sight as next-gen aims to restore vision

Behind Belite’s progression-slowing RBP4 inhibitor are a wave of therapies aiming to activate retinal function

Product Development

Emerging models point to a new operating system for rare disease innovation

It is time to integrate advances from around the globe to realize the potential to treat millions who suffer from very rare conditions: a Perspective

Editor's Commentary

Punching above its weight, Korea draws Western partners in CNS

A growing unpartnered CNS inventory meets rising Western appetite for BBB delivery and next-gen biologics

Deals

With $7.8B takeout, Gilead sees Arcellx’s cell therapy as competitive with J&J’s

Gilead takes full control, economics around registrational treatment for multiple myeloma as it prepares to take on Carvykti

Deals

Product Development

AtaiBeckley’s MDMA moves anxiety scales, but key questions remain for next trial

The psychedelic’s efficacy signal in social anxiety disorder is encouraging, but durability, effect size and dosing frequency need to be clarified

CagriSema’s commercial prospects dim further after head-to-head miss

Novo’s combo delivers less weight loss than tirzepatide in REDEFINE 4

Data Byte

‘NewCo Model’ maintains buzz, with debut of Solstice, Slate

With two more this week, the five NewCos announced this year add neurology and cell therapy to the East-West model

Novo’s ‘triple G’ shows competitive weight loss in partner’s Phase II

UBT251 delivers 17.7% placebo-adjusted loss at 24 weeks in China study

EMA’s CHMP recommends three new orphan drugs, rebuffs two FDA-approved programs

Plus positive recommendation for Moderna’s combined flu and COVID-19 mRNA vaccine

Discovery & Translation

Science Spotlight: Trio of papers decodes endometrial biology

Plus: Non-invasive antibiotic delivery to the ear and epigenome innovations with ties to companies

Regulation

FDA’s prosaic single-trial default standard

The policy shift is unlikely to live up to FDA Commissioner Makary’s prediction of a ‘surge’ in drug development

FDA U-turn brings Immedica’s therapy to patients with ultra-rare disease

Accelerated approval of Loargys follows 2023 refusal to file

Deals

With 35Pharma buy, GSK sees ‘best-in-class’ competitor to Winrevair in PAH

$950M takeout closely follows pharma’s $2.2B Rapt deal; both moves come shortly after new CEO Luke Miels succeeded Emma Walmsley

Finance

With $60M round, BreezeBio turns delivery platform into internal pipeline: Venture Report

Plus: Two new NewCos emerge, Alveus draws cash for obesity pipeline, and more

Generate IPO meets goal, but shares sink in aftermarket: Public Equity Report

Plus: Avidity spinout arrives on NASDAQ; five biotechs price follow-ons; and more

List of Western VCs tapping Japan biotech incentive continues to grow

RA Capital, The Column Group, TPG among firms selected by AMED for matching program

Biopharma Stock Performers

Use BioCentury's interactive dashboard to view top-performing biopharma stocks for the day and the week.

Product Development

Gossamer, Grail down by more than half after late-stage misses

Politics, Policy & Law

U.S. investigating Chinese state support, pricing in biotech sector

Deals

MGI divests Complete Genomics as Biosecure looms

Gilead’s Arcellx buy. Plus: ctDNA as surrogate endpoint — a BioCentury podcast

Management Tracks

Longtime Alkermes CEO Pops to hand baton to COO Jackson; Sarepta CEO to depart at year-end

Merck names Oosthuizen head of new cancer unit

BioCentury ISSN 1097-7201