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What’s in Today’s Brief? (March 7th Preview)
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FDA’s embattled vaccine chief Prasad exits again — April departure
Vinay Prasad will leave the FDA at the end of April, marking a second departure after a tenure marked by high-profile reversals and industry clashes. Multiple outlets reported the move; STAT and other outlets detailed controversies tied to vaccine and gene-therapy review decisions under Prasad’s leadership. The resignation follows public disputes over review pathways for Moderna’s flu shot and demands for additional trials on rare-disease therapies. The exit leaves the Center for Biologics Evaluation and Research (CBER) leadership in flux and raises immediate questions about ongoing reviews of vaccines, cell and gene therapies.
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Servier picks up Day One: $2.5B deal for pediatric glioma drug
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion, securing Ojemda (tovorafenib), an FDA‑approved therapy for pediatric low‑grade glioma, and an early‑to‑late-stage oncology pipeline. Company statements and filings show Servier will fund the purchase with cash and investments, and Day One’s shares jumped on the premium offer. Servier’s U.S. CEO David Lee framed the deal as a strategic push into rare cancers, aligning Ojemda with the company’s existing pediatric brain-tumor assets. The transaction consolidates a marketed pediatric oncology product with development-stage programs across adult and pediatric solid tumors.
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FDA doubles down on uniQure — defends sham‑controlled trial demand
The FDA has publicly defended reviewers’ request for a sham‑controlled randomized study for uniQure’s AMT‑130 Huntington’s gene therapy, rejecting the company’s characterisation of the procedure as ethically untenable. A senior, anonymous FDA official clarified that the agency asked for scalp incisions and anesthesia rather than full burr holes, and affirmed reviewers’ view that a randomized design is needed. UniQure has pushed back, citing prior pivotal Phase 1/2 results and accusing the agency of changing earlier guidance. The exchange highlights tension over trial design standards for surgically delivered gene therapies and underscores regulators’ insistence on randomized evidence for high‑risk neurologic interventions.
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Petrelintide underwhelms investors: Roche/Zealand readout misses expectations
Roche and Zealand Pharma reported Phase 2 ZUPREME‑1 results for amylin analogue petrelintide showing roughly 10.7% mean weight loss versus 1.7% for placebo — below investor expectations for a mid‑teens placebo‑adjusted outcome. Zealand’s shares plunged after the announcement and analysts questioned the drug’s differentiation in a crowded obesity market dominated by higher‑efficacy GLP‑1 candidates. Zealand maintained that safety and tolerability were encouraging and signalled plans for a Phase 3 program. The readout sharpens competitive dynamics among peptide-based obesity contenders and may reshape partner and investor interest in amylin analogues.
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CAR‑astrocyte therapy: single injection prevents and clears amyloid in mice
Researchers at Washington University engineered astrocytes expressing chimeric antigen receptors (CAR‑As) that prevented amyloid‑β plaque formation when given prophylactically and reduced established plaque burden by about half with a single injection in Alzheimer’s mouse models. The Science paper from Marco Colonna’s team details in‑brain cellular immunotherapy that leverages astrocytes’ abundance and longevity as an alternative to repeated antibody dosing. The authors note additional work is required to optimize delivery, dosing and safety before translational steps; CAR‑As represent a cell‑based approach distinct from monoclonal antibody strategies. CAR‑astrocytes may offer a path to durable central nervous system immunotherapies if peripheral and on‑target/off‑target risks can be managed.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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