BioCentury

Current Editions

February 10, 2025
Biotechs make inroads to precision medicine, solving long-standing problems

70% of new precision medicines approved by FDA in past three years were not sponsored by major pharmas

Product Development

Gene editing companies to gain from FDA’s platform designation update

An upcoming eligibility expansion a gene editing opportunity, but leaves AAVs in the dark

Product Development

The radiopharma landscape takes shape in neuroendocrine tumors

Itm and Perspective’s readouts are the latest clinical advances in GEP-NETs, the first indication to put radioligand therapies on the map

Product Development

Downsizing could cause FDA to miss PDUFA goals

Current, former agency staff say personnel losses from plans to slash government payrolls threaten short- and long-term harm

Politics, Policy & Law

White House plans to slash FDA, NIH would decimate agencies

Draft order would halve FDA staff, cut NIH, eliminate CDC, sources tell BioCentury

Politics, Policy & Law

Product Development

AI-based predictive biology coming soon, Foresite’s Bajaj says

CEO of Foresite Labs betting on integrating AI/MI with medical product R&D — The BioCentury Show

Novo believes new CagriSema trial can hit weight loss goal

Aims to drive additional weight loss after analysis of Phase III REDEFINE 1 obesity data

Emerging Company Profile

Linus: Unlocking biomarkers hidden in hair

N.J.-based company uses metabolites in hair strands to track biological responses to environmental exposures over time

Editor's Commentary

Has interest in ADCs peaked? — a Perspective

Pfizer’s drop of a late-stage ADC this week may signal the ADC frenzy is cooling

Guest Commentary

Call to action: Defending the NIH, the NSF and the foundation of American science — a Guest Commentary

There is an assault on the foundation of U.S. science: Silence is not an option

Rebuilding trust in FDA through labeling clarity and transparency

Regulatory agency must be proactive in fighting the surge in skepticism about the drugs and vaccines it regulates

Market Access

U.S. biosimilars held back by more than just reimbursement

Iqvia’s latest report cites regulatory requirements, investment costs, and lack of market acceptance and predictability

Discovery & Translation

Science Spotlight: New protein degradation mechanism

BioCentury’s roundup of translational innovations also includes new insight into repeat expansion in Huntington’s and 10 new products

Science Spotlight: Ranking AAV capsids for liver gene therapy

BioCentury’s roundup of translational innovation also includes high-resolution spatial proteomics, a more diverse microbiome atlas, and more

Deals

Under Bain’s ownership, Mitsubishi Tanabe to seek deals, growth in Japan

Japanese pharma’s parent chooses $3.4B buyout to create PE-backed standalone company

Finance

European start-ups Akribion, Aplagon each draw funding: Venture Report

German biotech Akribion advancing nucleases for programmable cell depletion; Finland’s Aplagon developing vascular treatment

Strong demand for Sionna latest good sign for IPOs: Public Equity Report

Vertex competitor posts a first-day gain after an upsized offering; plus financings for Gh Research and Tectonic

Australian radiopharma play Advancell taps VCs for $112M in ‘scale capital’

Expanding in U.S., the biotech will build manufacturing capacity for α-emitters, including clinical program for prostate cancer

Management Tracks

ElevAAte: Cultivating the next generation of East Asian American leaders

The non-profit launches to overcome C-suite underrepresentation by helping U.S. biopharma leaders of East Asian descent advance in their careers

Biopharma Stock Performers

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

BioCentury ISSN 1097-7201