Pharminent

CDER and CBER get permanent directors

HHS named Michael Davis to lead CDER and Karim Mikhail to lead CBER on September 8, converting both from acting roles as part of a four-person slate that included FDA’s first deputy commissioner for AI. Continuity at the two largest review centres while the commissioner seat awaits confirmation.

Salt-form cabozantinib walks past the patents

Handa Oncology won final approval for OMCAZIO (cabozantinib lauryl sulfate) in advanced RCC, HCC and epNET. A different salt form from Exelixis’ Cabometyx — a route that does not read on the malate estate, which makes it structurally unlike ordinary generic entry.

BioMarin runs two Voxzogo tracks — don’t merge them

FDA accepted an sNDA for full approval in achondroplasia; the 2021 clearance was an accelerated approval on a surrogate endpoint. Separately, a Phase 3 win in hypochondroplasia — a different skeletal dysplasia — supports a planned filing there.

New FDA oncology chief signals continuity

R. Angelo de Claro, confirmed permanent OCE director after acting in the role since December 2025, used his first interview to stress organisational continuity and regulatory modernisation. Directional intent rather than enacted policy — but relevant to accelerated approval and confirmatory trial expectations.

Atogepant hits in menstrual migraine

AbbVie’s Qulipta met the primary endpoint and all reported secondaries in the Phase 3 LUNA trial, using intermittent perimenstrual dosing. There is no approved targeted preventive in this indication, setting up a first-mover sNDA.

Semaglutide moves 40.4% of children below the obesity line

In the Phase 3 STEP Young trial, 40.4% of children on semaglutide plus lifestyle modification reached a BMI below the obesity threshold at 68 weeks. Enrolment went down to age 6, below the current U.S. approval for adolescents 12 and older.

Oral TLR7/8 antagonist clears Phase 2 in lupus

Beeline Medicines’ afimetoran met its primary endpoint in a global Phase 2 in SLE, moving to Phase 3 across two lupus indications. An oral option in a space held by the injectable biologics anifrolumab and belimumab. The asset originated at Bristol Myers Squibb.

79% response — and still below the bar

Tyra’s dabogratinib posted a 79% response rate in Phase 2 SURF302, under analyst expectations. Note the setting: low-grade intermediate-risk non-muscle-invasive bladder cancer, where the comparator is repeat resection — not erdafitinib, which is approved in metastatic disease.

Encoded raises $275M for Dravet gene therapy

A Series F with GV among the backers funds ETX101, an AAV gene therapy for Dravet syndrome, through pivotal development plus internal manufacturing build-out. One of the larger gene therapy financings of 2026.

Samsung Biologics books $262M through 2033

A manufacturing contract with an undisclosed European pharma client. The multi-year tenor is the notable feature — long-duration bookings lock in capacity utilisation. Samsung’s separate move into peptide manufacturing via acquisition remains pending.

Solstice launches with $225M for porustobart

An unusually large Series A for a single-asset company, led by RA Capital, taking the next-generation CTLA-4 antibody porustobart into Phase 2 as a neoadjuvant immuno-oncology therapy. Continued institutional appetite for differentiated checkpoint biology.

Argonaut sheds diagnostics to focus on fill-finish

The CDMO divested its life sciences and diagnostics division to private equity firm 1315 Capital, concentrating on aseptic fill-finish for injectable biologics. Deal terms and the unit’s revenue contribution were not disclosed.

Sandoz targets 100+ biosimilars by 2040 — from 13 today

The 13-to-100 baseline is what makes the target aggressive: roughly a sevenfold portfolio expansion, backed by a $300M drug substance facility in Ljubljana and a vertically integrated supply chain, alongside a goal of more than doubling sales by 2035.

Takeda’s R&D chief to retire in June 2027

Andy Plump departs after roughly 12 years with no successor named; he stays in post until one is found. Watch whether the hire is internal — implying continuity in the partnership-heavy model he built — or external, which more often precedes portfolio pruning.

Novartis shareholders press on M&A discipline

Investor scrutiny is rising after setbacks to pipeline and commercial assets sourced through acquisition, raising questions about deal diligence and integration at a company that has leaned heavily on external innovation.

Winners this week

Under pressure

Neutral but pivotal

Also inside

Data Snapshot

The numbers that matter: 563 patients in DeLLphi-305 · 40.4% of children below the obesity line in STEP Young · $275M Encoded Series F · $262M Samsung Biologics booking · 100 Sandoz biosimilars by 2040.

Also inside

What to Watch Next

Forward catalysts: the DeLLphi-305 hazard ratio and CRS rates that decide whether maintenance gets a third drug · Tyra’s organ-sparing pivotal design · Takeda’s R&D succession ahead of June 2027.

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