Top Story Today
Colorado Got the Green Light to Import Canadian Drugs. Now Comes the Hard Part.
Colorado became only the second state (after Florida) to win FDA authorization for importing prescription drugs from Canada, a move the state says could save consumers $51 million over three years. But don't expect pills to cross the border anytime soon. Each of the 24 drugs and dosages on Colorado's list still needs individual FDA approval before a single tablet ships. And there's an even bigger problem: Canada doesn't want to play along. Ottawa has maintained export restrictions since 2020, and when Colorado approached 23 manufacturers last year, none agreed to supply drugs. The real power of this authorization may be the threat it poses, not the imports it delivers.
Why it matters: The precedent matters more than the pills. Every state that clears the FDA's importation pathway turns up the political pressure on U.S. drug pricing, giving lawmakers and negotiators a concrete benchmark (Canadian prices roughly 50-55% lower than U.S. prices) to wave in every boardroom and hearing room.
Read more →Deals and M&A
UCB Bets $2 Billion on a Cancer Drug Repurposed for Autoimmune Disease
UCB is paying $2 billion upfront (up to $2.2 billion total) for Candid Therapeutics, a two-year-old startup using T-cell engagers, antibodies originally designed to kill cancer cells, to wipe out the rogue immune cells behind autoimmune diseases. The lead drug has treated 68 patients across lupus, myasthenia gravis, and other conditions, but no pivotal trial has read out yet. UCB is betting the approach could deliver CAR-T-level immune resets in a simple, off-the-shelf injection.
Read more →Chiesi Pays $1.9 Billion for the First Oral Pill That Treats HAE Attacks
Every on-demand treatment for hereditary angioedema required a needle until KalVista's EKTERLY came along. The oral pill blocks plasma kallikrein within about 15 minutes of dosing, and its Phase 3 trial showed symptom relief in 1.79 hours versus 6.72 on placebo. Italy's Chiesi closed the $1.9 billion acquisition in June, making it the biggest deal in the company's history and a cornerstone of its growing rare disease franchise.
Read more →Adaptive Biotech Is Breaking Up With Itself
Adaptive Biotechnologies plans to split its profitable cancer diagnostics business (clonoSEQ, $212 million in 2025 revenue, growing 53% in Q1 2026) from its speculative AI-powered drug discovery platform. The diagnostics side has 70%-plus gross margins and clear growth. The drug discovery arm brought in $3.8 million last quarter. Two businesses, two investor bases, one stock ticker that satisfied neither. Structure TBD by year end.
Read more →Clinical and Regulatory
One CRISPR Infusion Knocked Out 87% of HAE Attacks. The Effect Is Holding Past Two Years.
Intellia's lonvo-z delivered an 87% reduction in monthly hereditary angioedema attacks versus placebo with a single infusion, and 62% of patients were completely attack-free at six months. Long-term Phase 1 follow-up is even more striking: 98% attack reduction sustained past 23 months. If approved (BLA filing targeted for a 2027 launch), it would be the first systemic in vivo CRISPR therapy to reach market.
Read more →Spyre Posts the Strongest Histologic Data Yet in the Anti-TL1A Race for UC
Spyre's SPY002 hit a 10.7-point reduction on the Robarts Histopathology Index in ulcerative colitis, blowing past the 7-point threshold for meaningful improvement. Clinical remission reached 33% and endoscopic improvement hit 42% at 12 weeks. Analysts at Guggenheim maintained a $115 price target. The catch: this was open-label data. Placebo-controlled results from Part B aren't expected until 2027.
Read more →Neumora's Depression Drug Went 0-for-3. The Stock Is Under a Dollar.
Navacaprant failed all three Phase 3 depression trials with a combined effect size of essentially zero. In one study, placebo actually beat the drug. Neumora's stock went from $11 to under $1, the company cut 35% of staff, and it's now pivoting to early-stage programs in Alzheimer's agitation, schizophrenia, and obesity with cash runway guided into Q3 2027.
Read more →Policy and Transparency
Medicare Wants to Block Pharma's Favorite Pricing Escape Hatch
CMS proposed a rule that would treat subcutaneous reformulations of Keytruda and Opdivo as the same drug as the original IV versions for Medicare negotiation purposes. That closes the strategy of filing new FDA approvals to reset the IRA negotiation clock. With $41 billion in combined sales at stake and comments due August 17, the concrete is being mixed on a tunnel Merck and BMS spent years digging.
Read more →Europe's Clinical Trial Registry Is Missing Half Its Results
A new analysis of 234 European clinical trials found fewer than half posted results on time, and only 42% had fully complete summaries. Academic sponsors are the worst offenders, though industry's compliance rate still leaves a significant share of trials overdue. Individual EU member states have fining authority for noncompliance; they just aren't using it.
Read more →