Weight Loss Waves, Pazdur’s Exit and FDA Instability, New Neuro Breakthroughs

Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.

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Pfizer followed up its winning $10 billion bid for obesity startup Metsera by adding another molecule to its obesity cabinet, this one from Chinese firm YaoPharma in a deal worth up to $1.9 billion licensing deal announced Tuesday. Meanwhile, Wave Life Sciences and Structure Therapeutics may have changed the weight loss landscape with early and mid-stage data from their candidates that analysts called “very disruptive” and “highly competitive,” respectively.

At the FDA, the confusion and instability continue with the retirement of agency veteran Richard Pazdur just three weeks into his role as CDER director. Pazdur’s exit leaves the FDA with just three veteran leaders from one year ago. The CDC similarly made headlines last week as the revamped vaccines advisory committee voted to recommend postponing the hepatitis B vaccination from birth to two months of age for some infants.

Meanwhile, the Clinical Trials on Alzheimer’s Disease (CTAD) conference generated excitement in the space as Roche, Eisai and others presented new data from their respective candidates. The star of the show was Roche’s next-gen antibody trontinemab, which lowered amyloid levels below the threshold of positivity in 92% of treated patients in a mid-stage study. Meanwhile, Eisai is determined to buck the losing the trend in the anti-tau space. The company’s etalanetug reduced all measurable forms of MTBR-tau243—a specific biomarker of tau tangle pathology in Alzheimer’s—in a Phase Ib/II trial, according to an oral presentation at CTAD.

Finally, check out this week’s deep dives in BioPharm Executive on what pharmas are learning from the Chinese biotech sector and how Japan’s pharma industry is setting its sights on the global market.

Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
Jef Akst is managing editor of BioSpace. You can reach her at jef.akst@biospace.com. Follow her on LinkedIn and Twitter @JefAkst.
Annalee Armstrong is senior editor at BioSpace. You can reach her at  annalee.armstrong@biospace.com. Follow her on LinkedIn.
Dan Samorodnitsky is the news editor at BioSpace. You can reach him at dan.samorodnitsky@biospace.com.
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