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Avian flu has jumped from birds to cows to humans. The U.S. is flying blind Rick Bright warns. It is either the start of a serious outbreak or a fire drill. Either way, the U.S. needs to do much better. Watch at tinyurl.com/46xyhna4 or listen at tinyurl.com/46xyhna4

U.S.-China cross-border biotech $CNTB rejiggers C-suite, board, w/Chinese co-founders narrowing roles as vets from San Diego’s $HRTX take top posts & board member Kleanthis Xanthopoulos becomes chair. Connect also leaning into its U.S. colors -- not long after $IMAB did same

Vladimir Pravdin spent 2 years as a guest of the U.S. government in a federal penitentiary, murdered a colleague in Switzerland, and headed TASS and Soviet intelligence in the U.S. during WWII. More at the Journal of Cold war History:direct.mit.edu/jcws/article/2…

FDA has a different Peter principle problem: poorly articulated, idiosyncratic decision-making. In a BioCentury Editor's Comment, @SteveUsdin1 argues that U.S. FDA approval of Sarepta Therapeutics's gene therapy exposed management failures. biocentury.com/article/652791

In a BioCentury Editor's Commentary, Washington Editor @SteveUsdin1 argues that U.S. FDA approval of Sarepta Therapeutics's gene therapy exposed management failures. $SRPT buff.ly/3KWG79R

$ALNY's goal is to become a top-five biotech by 2025: today's HELIOS-B data helped it leapfrog $argx & $bntx to slide into seventh place

Approval of Sarepta DMD gene therapy revives questions on FDA interactions with companies, patient advocates CBER Director Marks met with biopharma companies, industry-funded advocates while considering gene therapy application ($) biocentury.com/article/652830

Fun fact: I signed a contract in 1776 that in exchange for a summer of gloom, I'll disappear on the 4th of July once every twenty years. This is that year.

Now we’re talking

Calling on translational academics! Do you find it hard to meet #biotech VCs and pharmas? Do you have results and an idea that you'd like to showcase? BioCentury's Grand Rounds conference is designed for you. Sept 9-11, Nashville, TN. Find out more: conferences.biocentury.com/grand-rounds

.U.S. FDA approves vorasidenib from Servier for IDH-mutant Glioma. In Ph 3, the tx led to a median PFS of 27.7 months vs. 11.1 months for placebo, for a risk reduction of 61% (p=0.000000067). That's a lot of zeros!

In an exclusive conversation with BioCentury, Jim Wilson describes how he plans to use newly launched GemmaBio as a vehicle to create a sustainable model for ultrarare disease gene therapies by capitalizing on efficiencies gained from a platform model. biocentury.com/article/653189

Three's a crowd? MBX follows Claire Mazumdar's Bicara Therapeutics, Lonnie Moulder's Zenas BioPharma into IPO queue. The Indiana developer of long-acting peptide therapeutics is latest mid-to-late-stage biotech to seek NASDAQ listing. Paul Bonanos in BioCentury: biocentury.com/article/653368

A 4th biotech has filed to go public on NASDAQ -- on heels of MBX, Bicara, Zenas. Some momentum for a mini-window ahead of the election? Obesity play BioAge Labs' top shareholders: CEO Kristen Fortney, a16z, Khosla, Sofinnova (US), Longitude, RA, Cormorant h/t Paul Bonanos

Incubated by Samsara, led by ex $GILD liver disease top cat Mani Subramanian, OrsoBio now has $164M+ after a series B co-led by Ascenta, Woodline. BioCentury's Paul Bonanos spoke w/ Mani last fall about modulating energy to address obesity, diabetes & more biocentury.com/article/650574

Very much looking forward to this triple header when they hit the Frisk next month

.@NovoNordisk's iNNvest's 1st deal is in obesity play & VIB spinout Tanai. BioCentury's Paul Bonanos speaks w/$NVO's Karin Conde-Knape, Miriam Frieden on iNNvest, which emphasizes proximity to emerging cardiometabolic science, not returns. biocentury.com/article/653591

Launching w/ $75M, start-up GCTx aims to shortcut the cell therapy manufacturing process by activating transcription factors involved in cell fate. BioCentury's Danielle Golovin profiles the newco, which has origins in George Church's Harvard Medical School lab biocentury.com/article/653593