Regulatory

A spectator in silhouette leans over a glass railing and raises an arm toward a baseball field during a night game, with two players standing on the infield below.

Watchdog Wednesday: When Enforcing Your Patent Becomes A Problem

The FTC has told a federal appeals court that what J&J did to competition matters more than what it meant to do. That, along with a big recent Takeda verdict, should change how you think about every defensive patent move.

Jul 1, 2026 Nielsen Hobbs 5 min read members Featured

Watchdog Wednesday: The First JCA Was a Fire Drill

The EU’s debut Joint Clinical Assessment was run on a drug that exposes every trap waiting for orphan developers in 2028.

Jun 24, 2026 Nielsen Hobbs 6 min read members

Watchdog Wednesday: Reading the FDA’s Mixed Signals on Rare Diseases

Sponsors keep misreading red flags for green, yet the traits FDA actually falls for are predictable enough to plan a whole program around.

Jun 17, 2026 Capsul Desk 5 min read members

Milestone Monday: What You'll Pay & Who You're Allowed to Pay It To

GSK spends $10.6bn to outrun a patent cliff while the Pentagon quietly reprices the supply chain underneath everyone. Two different bets on the same question: what is access actually worth.

Jun 15, 2026 Capsul Desk 10 min read members

In the foreground is a chess board with a queen patterned to resemble the UK flag. In the background there is a blurry hospital bed with an in-focus IV line.

Watchdog Wednesday: The UK’s Express Lane for Latecomers

The UK's new "notifiable trial" route can shave weeks off your timeline, but only if you sequence your jurisdictions like a chess player rather than a tourist.

Jun 10, 2026 Nielsen Hobbs 5 min read members

Watchdog Wednesday: US FDA’s AI Trial Revolution Gets Rescheduled

The AI trial pilot survived its own architects' departure. For one more month, the docket is where it gets decided.

Jun 3, 2026 Nielsen Hobbs 4 min read members

Watchdog Wednesday: The EU’s Modular Exclusivity Era Has Arrived

The EU pharma reform package has a 2028 implementation date. That is not a reason to wait.

May 27, 2026 Nielsen Hobbs 5 min read members

Watchdog Wednesday: The FDA's New Front Door Is Not Where You Think

Meetings often get a bad rap around the office water cooler or in popular media, be it through Jack Donaghy’s “Four Chairs. Four!” line in 30 Rock or the

May 20, 2026 Nielsen Hobbs 5 min read members

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