Your essential biotech, medtech, and pharma recap — no noise, just what matters.

It's over. Makary tried to hold the center between the MAHA agenda and traditional FDA regulation, and in the end, neither side was satisfied. Harvard's Dr. Aaron Kesselheim told Democracy Now: "Nobody was happy with what he did." The final straw was e-cigarettes, not drugs. Makary opposed authorizing fruit-flavored vapes because of their appeal to young people. He was overruled. A source told CNN: "He doesn't want to approve youth-appealing flavors, but has been forced to by the powers that be." He resigned Tuesday, one day before he was scheduled to testify before the Senate on the FDA's proposed budget. CNBC reported that a senior administration official "couldn't point to one issue" but described "a buildup of many problems," including abortion policy. Kennedy praised Makary on social media but said the search for a replacement "is already underway." The practical impact on pharma is immediate: PDUFA reauthorization negotiations are underway, the CNPV program has active filings (Revolution Medicines, Lilly T2D), the Expedited IND pathway needs a champion, and the RTCT pilot is supposed to launch this summer. All of this is now in the hands of Kyle Diamantas, a food safety official with no drug development background. The industry's chief regulator is gone, and the three most important Senate-confirmed health positions in the country are sitting empty. 👉 Read Full Analysis

European Mid-Caps Are Buying American Biotechs at an Accelerating Pace

BioSpace reported on Tuesday that mid-sized European drugmakers are "snapping up US biotechs" at an accelerating pace, with differing views on whether the activity represents "the rise of a new buyer class or a quirk of timing." Recent deals from European acquirers include:

Combined, European mid-cap acquirers have deployed more than $5.5B in announced deals in the past month. The drivers are similar to their U.S. counterparts: patent cliff pressure, pipeline gaps, and attractive biotech valuations. But the pattern is new. Historically, cross-border biopharma M&A has been dominated by mega-cap acquirers (Novartis, Roche, AstraZeneca, Sanofi). The emergence of Chiesi, Angelini, UCB, and LEO as active buyers signals that the M&A wave has broadened beyond the usual suspects.

New Guidelines Push for More Aggressive LDL Reduction

New cardiovascular guidelines from the American Heart Association and American College of Cardiology call for more aggressive management of LDL cholesterol, emphasizing sustained low levels of apolipoprotein B and LDL particles as key targets, according to BioSpace. Merck and Amgen are "doubling down" on the opportunity. Merck is advancing its PCSK9 program, and Amgen's Repatha franchise is positioned to benefit from broadened treatment recommendations. The guidelines could expand the addressable market for PCSK9 inhibitors and next-generation lipid-lowering agents significantly, particularly among patients who do not achieve adequate control on statins alone.

BridgeBio's Attruby Shows Survival Signal vs. Pfizer's Tafamidis in ATTR-CM

BioSpace reported that indirect comparisons between BridgeBio's Attruby and Pfizer's tafamidis products showed a numerical survival benefit with BridgeBio's drug in transthyretin amyloid cardiomyopathy (ATTR-CM). While indirect comparisons carry significant limitations, the data position Attruby as a potentially differentiated competitor in the ATTR-CM market. The class generates multi-billion dollar revenue for Pfizer and represents one of the fastest-growing segments in cardiovascular medicine.

👉 Read Full Analysis

The situation is now worse than we outlined on Monday. On Monday, Makary's departure was planned but not executed. Now it is done. Here is the updated status of every key initiative:

CNPV Program: OPERATING but uncertain. Three NMEs approved (Foundayo, Otarmeni, plus Bizengri under accelerated review). Psychedelic CNPVs issued. Revolution Medicines and Lilly T2D filings are planned. Risk level elevated from MODERATE to HIGH. Diamantas has no track record on drug development decisions.

Expedited IND Pathway: STALLED. This was Makary's signature legislative proposal. Without a commissioner advocating for it in Congress, the proposal is unlikely to survive PDUFA negotiations. Risk level: VERY HIGH.

Real-Time Clinical Trial Pilot: UNCERTAIN. AstraZeneca and Amgen pilots are operational. Public comment period closes May 29. But the broader pilot launch planned for this summer requires leadership direction. Risk level: MODERATE to HIGH.

PDUFA Reauthorization: COMPLICATED. The Prescription Drug User Fee Act expires September 30, 2027. Industry negotiations are underway. A leadership vacuum at the FDA introduces uncertainty into fee structures, review timelines, and performance goals that affect every company filing an NDA or BLA.

FDA Staffing: CRITICAL. Former cancer regulator Dr. Richard Pazdur cited Makary's leadership as his reason for leaving. Multiple senior scientists departed during his tenure. Staff morale is described as having "plummeted." Rebuilding institutional expertise takes years, not months.

💊 The European Buyer Thesis

The emergence of European mid-caps as active U.S. biotech acquirers reflects a structural shift. These companies face the same pipeline pressures as mega-caps but with smaller balance sheets, making U.S. clinical-stage biotechs (which are priced well below 2021 highs) particularly attractive targets.

The pattern: European companies with established commercial franchises in specific therapeutic areas are acquiring U.S. biotechs to extend those franchises. UCB (immunology/neuroscience) bought Candid (autoimmune TCE) and Neurona (epilepsy cell therapy). Chiesi (rare disease) bought KalVista (HAE). Angelini (neurology) bought Catalyst (Lambert-Eaton). LEO Pharma (dermatology) bought Replay (gene therapy for genetic skin disease).

BioSpace noted "differing views on whether the activity represents the rise of a new buyer class or a quirk of timing." The consistency of the strategic logic across four different companies suggests this is structural, not coincidental. Expect more European mid-cap deals in H2 2026.

📊 Cardiovascular: The Next Growth Vertical

The updated AHA/ACC guidelines expand the population eligible for aggressive lipid management, particularly PCSK9 inhibitors (Repatha, Praluent) and emerging agents. BioSpace reported Merck and Amgen are "doubling down" on the opportunity.

The cardiovascular drug market has been quiet relative to oncology and GLP-1 in recent years. These guidelines could change that. If PCSK9 inhibitors move from specialty prescribing to broader primary care use, the revenue opportunity expands significantly. Amgen's Repatha and Regeneron/Sanofi's Praluent are positioned to benefit immediately. Next-generation lipid agents (inclisiran, bempedoic acid combinations) also gain relevance.

For our readers: cardiovascular is a vertical we have covered lightly in this series. With new guidelines, active pipeline investment from Merck and Amgen, and BridgeBio's ATTR-CM data challenging Pfizer, expect more CV coverage in the weeks ahead.

🎯 Catalyst Calendar: May 2026 Forward

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