BioCentury

Current Editions

November 3, 2025
Tidmarsh signals higher bar for accelerated approvals but faster trial starts

CDER director says FDA is re-evaluating cancer endpoints and moving to speed clinical trial regulation, including IND process

Politics, Policy & Law

Intrigue builds as Novo goes public with higher Metsera bid

Disputing legitimacy of rival bid, Pfizer has brief window to renegotiate or pursue legal, political alternatives

Deals

Rolling your sleeves up: Behind the scenes of a biotech takeout with Sophie Kornowski

Fresh off a $1.2B takeout of Boston Pharma by GSK, Kornowski parlays her years in pharma BD into lessons for biotechs, on The BioCentury Show

Deals

Product Development

China’s Innovation Moment: Takeaways from the 12th China Healthcare Summit

On BioCentury’s latest podcast: Paradigm-shifting speed of development, landmark deals, homegrown talent and a surging Hong Kong market

Emerging Company Profile

Dispatch Bio: Toward tumor-agnostic immunotherapy

Philadelphia-based newco designing a two-part therapy for use across many solid tumor types

Data Byte

Data comp: How the most-advanced Lp(a) therapies stacked up in Phase II

Despite pelacarsen’s first-mover advantage, olpasiran and lepodisiran offer speedier, longer-lasting Lp(a) reduction with less frequent dosing

At least four PDUFA dates on FDA’s November docket

Decisions expected for Arrowhead siRNA, Kura AML small molecule

Discovery & Translation

Science Spotlight: Autoimmune Treg therapy from Nobel Prize winner Sakaguchi

BioCentury’s translational roundup also highlights five papers on delivery advances

Regulation

CDER Director George Tidmarsh’s biomarker comments, in his own words 

Tidmarsh said FDA has launched an initiative to assess surrogate endpoints for accelerated approval in cancer and other diseases

Deals

Novartis’ biggest deal in years complements its gene therapies with late-stage antibody-oligonucleotide conjugates

The pharma’s $12B Avidity takeout delivers trio of programs for muscular dystrophies, all nearing regulatory submission; cardio spinout to follow

Finance

Hong Kong queue swells with IPO, dual listing candidates: Finance Report

BrightGene, NovaBridge, Alebund, Ribo and Lupeng all seek HKSE offerings; MapLight gives back its gains; and more

Biopharma Stock Performers

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

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