BioCentury

Current Editions

November 24, 2025
NLRP3 for obesity: Real or mirage?

Competitors hope better brain penetration will lead to weight loss despite the Phase II miss of Ventyx’s VTX3232

Product Development

Al Sandrock on why neurology might finally be ready to accelerate

From an array of genetic targets to brain-penetrant delivery systems, Voyager CEO sees the pieces finally aligning for neurology-wide progress

Product Development

China biopharma — enter the Oktagon

The world’s toughest arena for drug innovation; will biotech go the way of EVs?

Guest Commentary

FDA should take a more active role in updating drug labels — when there’s strong evidence

A system built for pharma will never realize the full potential of generics, but FDA can help fix this, argue Woodcock, Duke’s Boyer and Williams

Guest Commentary

Kennedy, Makary vows to avoid political interference at CDER will be tested soon

Makary’s reviews of puberty-blockers, SSRIs, involvement in CDER personnel decisions possible flashpoints

Regulation

Product Development

OXR2 agonists show efficacy beyond narcolepsy type 1

With Phase II data from Alkermes and Centessa, OXR2 utility broadens. Centessa’s ORX750 appears the stronger of the two in NT2.

Front Row with BioCentury: The Rapid Rise of Base Editing

With nearly two dozen base editors in the clinic, the nascent technology’s potential is coming into focus

Emerging Company Profile

Iambic: Turning AI and automation into a two-year chemistry-to-clinic cycle

San Diego company’s physics-informed algorithms have begun delivering small molecules to the clinic in two years — and attracting partners

Editor's Commentary

Is there still a commercial opportunity for CRISPR-Cas9 therapies? A perspective

With RNA therapies surging and base editors advancing into the clinic, conventional CRISPR-Cas9 is facing its toughest competitive landscape yet

Data Byte

NME approvals by FDA’s CDER reach 37, tying 2022

Tally could rise quickly as flurries of approvals common near year-end

Regulation

Sydnexis setback highlights FDA’s  lack of transparency, concerns about shifting goalposts

Company’s complete response letter is a poster child for the benefits of public advisory committee meetings

Politics, Policy & Law

Rep. Auchincloss accuses Makary of politicizing FDA

In letter reiterating concerns about CNPV program, Massachusetts lawmaker outlines broader concerns

Deals

J&J sees value beyond lead prostate cancer program in $3B Halda takeout

Privately held Yale spinout delivered first-in-human data for RIPTAC molecule last month, spurring deal

Finance

Sofinnova draws outsized LP interest in new €650M flagship fund

Investors attracted to track record, see path to returns as pharmas’ appetite for M&A remains strong

First projects revealed under Flagship/GSK partnership: Venture Report

Plus: Nine-figure rounds for Solve, Artios and Aspen; and more

Four companies raise nearly $950M in follow-ons: Public Equity Report

Nuvalent, Olema, Invivyd and Inhibikase all price offerings, as some take advantage of other companies’ news

Management Tracks

Remembering Francesco Sinigaglia, a biotech pioneer in Italy

Led the development of Oxervate to treat rare eye disease

Biopharma Stock Performers

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

BioCentury ISSN 1097-7201