.@US_FDA names six new products for commissioner's vouchers: A BioCentury Data Byte

.@EliLillyandCo sets the bar for #amylin with #eloralintide weight loss data. Amylin monotherapy shows similar weight loss to market-leading Zepbound tirzepatide at @ObesityWeek #OW2025. @StephenPHansen has the analysis in BioCentury $LLY $MTSR $NVO

Jim Wilson’s rethink of funding model underscores ultrarare headwinds. Gemma Bio pivots toward larger orphan markets, spins out ultrarare programs into RareTx

The approval of J&J's Caplyta for major depressive disorder clears a path toward blockbuster sales of the therapy acquired with Intra-Cellular this year, as the pharma projects a $5B goal $JNJ

BioCentury's translational roundup includes methods to alter tissue tropism of virus-like particles, advances in preeclampsia, and several papers from newcos

$NXXT: The Tell - Converts priced at $1.82, warrants at $5.00 → incentive to guide price back to their “control zone.” Probable accumulation $1.55–1.60; near-term magnet $1.82–2.00. Trigger: Volume spike + VWAP > $1.70. Not financial advice—one trader’s view.

Will U.S. public policy usher in an era of cures or cuts? Decisions made today will shape whether the U.S. leads a new era of curative medicine or retreats into risk aversion, argues Max Bronstein in a BioCentury Guest Commentary

BioCentury's latest biopharma management moves: J&J alum Najat Khan named CEO of Recursion. Plus: Prime Medicine hires Matthew Hawryluk as CBO and updates from Atrogi, Esperion, Bioversys

FDA approved only 2 NMEs in October: a BioCentury Data Byte

Biohaven's CRL in spinocerebellar ataxia is the latest evidence that FDA is less receptive to data packages featuring matched historical controls -- and it puts the company in a financial bind as it seeks to move its pipeline forward

Detailed CagriSema data from @NovoNordisk challenge amylin as a muscle-sparing mechanism @ObesityWeek #OW2025. @StephenPHansen analyzes the data in BioCentury

.@US_FDA Commissioner Marty Makary asked Rick Pazdur to serve as CDER director in the wake of Tidmarsh’s ouster -- the OCE director declined

BioCentury's latest biopharma management moves: New CEO for neuroscience start-up Draig is Ivana Magovčević-Liebisch. Plus: Syncona accelerator Slingshot hires John Isaac, Bobby Soni and updates from Target RWE, Forbion, Vor, Ascelia

A trio of CAR T updates in BioCentury's latest Clinical Report. Caribou reports allogeneic data in two cancer indications as Kyverna readies to bring an autoimmune CAR T into Phase III

Will Sarepta’s confirmatory misses test @US_FDA’s resolve on clinical outcomes? The biotech's Vyondys 53 and Amondys 45 miss primary endpoint in confirmatory trial

Blackstone Life Sciences is supplying $700M to @Merck in support of a broad Phase III program for sac-TMT, an antibody-drug conjugate to which the pharma holds rights under a deal with Sichuan Kelun

Novo remains on top as bidding war intensifies for #obesity play Metsera, with Novo's bid of up to $10B outshining Pfizer's revised bid of up to $8.1B $NVO $PFE $MTSR

In BioCentury's Deals Report: Neurocrine taps China-based TransThera for NLRP3 deal; Roche and Manifold in BBB-crossing agreement; a regional deal for 4D and Otsuka; Pfizer's lawsuits to block Novo's bid for Metsera; and more

Last week, George Tidmarsh described his recruitment as @US_FDA's CDER director. It was based on his bond with NIH Director Jay Bhattacharya.

.@US_FDA's George Tidmarsh says he was ousted over objections to a voucher program, but the move seems to have been precipitated by a lawsuit alleging ethics lapses

China’s Innovation Moment: Takeaways from the 12th China Healthcare Summit: Paradigm-shifting speed of development, landmark deals, homegrown talent and a surging Hong Kong market. with @BioPharmaJosh @FishburnSimone @Jeff_Cranmer

Six hours. That’s all it took for a small business to get slammed with a 50% tariff. Elana Woldenberg Ruffman, VP of Marketing and Product Development at @hand2mind, shares how “emergency” tariffs forced her team to sprint across continents to make a children’s toy—only to be