BioCentury

Current Editions

May 5, 2025
Deep learning takes protein design to new heights: a Q&A with David Baker

AI models will create whole new classes of therapies, by design

Discovery & Translation

A tale of three disconnects: BioCentury’s sentiment survey reveals major chasms 

Silent leadership, FDA cuts and lack of public trust are cracking biotech’s foundations — Editor’s Commentary

Editor's Commentary

The modern biotech chief commercial officer: skills for success — a Guest Commentary

The CCO role is evolving, argue John Archer and Roger Longman, as applicants must challenge entrenched views and manage a growing set of stakeholders with creativity

Guest Commentary

BIO campaign adds industry voice to pro-vaccine chorus

Public health groups, industry trying to counter flood of anti-vaccine messaging — including from Trump administration officials

Politics, Policy & Law

Biopharma industry confident of IRA fix, hoping to dodge MFN

GOP appears willing to fix the ‘pill penalty,’ Trump is pushing for Medicaid most favored nation also

Politics, Policy & Law

An opportunity that Europe didn’t ask for 

VIB’s Jérôme van Biervliet says on The BioCentury Show that Europe needs to fulfill its long overdue mission in biotech as the U.S. enters uncertain terrain

Finance

Product Development

Jemperli data create line of sight to organ-sparing in rectal cancer and beyond

GSK’s Jemperli leads to sustained clinical complete responses in 95% of rectal cancer patients

Emerging Company Profile

Radiant: Taking valency and multi-specificity up several notches

Canadian start-up’s self-assembling scaffold creates high avidity antibodies against challenging targets

Guest Commentary

Safeguarding sound decision-making at FDA: Guest Commentary

Political interference in product reviews threatens to undermine FDA’s credibility

Data Byte

Moderna’s May PDUFA date to offer next signal on FDA vaccine policy

A next-gen COVID vaccine among eight FDA decisions due in May

Regulation

Makary takes reorg off the table, leaving many empty seats to fill

The FDA commissioner says he’ll retain existing structure, which will require recruiting staff to fill critical positions

FDA misses PDUFA goal for Stealth’s Barth syndrome treatment

It isn’t clear whether staffing cuts or loss of FDA champions have caused FDA to miss the PDUFA goal for an ultrarare disease therapy

Politics, Policy & Law

Politics intrudes into Trump administration’s regulation of vaccines

FDA, HHS allow political appointees to make regulatory decisions about Novavax’s COVID vaccine based on unscientific rationales

Trump administration turning anti-vaccine rhetoric into policy

New HHS vaccine policy could make it impossible to launch improved versions of vaccines

Deals

Kidney disease readout sets up Regulus for Novartis buyout

Structured deal could double the payout to Regulus’ shareholders if microRNA therapy, headed for Phase III testing in ADPKD, wins U.S. approval

Eight-year-run for Pfizer spinout Springworks culminates in Merck KGaA buyout

German pharma adds drugs for rare tumors, expands U.S. footprint via $3.9B acquisition

Biopharma Stock Performers

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

BioCentury ISSN 1097-7201