Results of the survey are in the link below. The first half of 2025 may go down as the time when the golden era of biotech gave way to its darkest days in decades. Market collapse, hollowing out of FDA, decline of US preeminence all weigh on biomedical science. www.biocentury.com/marketing/us...

FDA misses PDUFA goal for Stealth’s Barth syndrome treatment It isn’t clear whether staffing cuts or loss of FDA champions have caused FDA to miss the PDUFA goal for an ultrarare disease therapy. www.biocentury.com/article/655776

Results out later today! Stay tuned...

Hear David Altshuler from @vertexpharm.bsky.social talk about everything from causal biology to how Vertex set out to beat the odds to the very cool items on the shelves behind him. Via @biocentury.bsky.social - open access on YouTube www.youtube.com/watch?v=Zwqn...

Curevo will put a new $110m round toward development of its Shringrix competitor, which it believes has tolerability advantages over the incumbent shingles vaccine. I spoke with the company, new board member Moncef Slaoui (ex-GSK) and lead investor Medicxi. Story: www.biocentury.com/article/6553...

John Maraganore - biotech veteran and leader - tells biotechs to embrace not fear the innovation coming out of China. Competition is good, he argues, and innovation is good wherever it comes from. Respond by matching and outcompeting it. @jmaraganore.bsky.social www.biocentury.com/article/655098

Trump 2.0's plans to slash FDA,NIH risk decimating 2 agencies at the core of U.S. biomedical innovation. @steveusdin.bsky.social @fishburnsimone.bsky.social join me to discuss what's at stake for biotech on the latest #BioCenturyThisWeek podcast. Available wherever you get your pods.

The disruption at NIH has some long-term consequences I argue here. Aside from DEI, WFH etc - this will impair the U.S. preeminence in biomedical science, and that's not good for biotech. www.biocentury.com/article/654890

The NewCo model in which Asia assets are taken to create startups in the U.S. might not sound that new. But it stands out in several ways, and, importantly, shows how fast innovation is happening in China. This is one of the hottest stories in biotech this year. www.biocentury.com/article/654859

Asia's "NewCo Model" kicked off in '21 with the launch of Arrivent and has hit its stride with 9 "NewCo" biotechs -- Asian assets with Western VC $ -- launching since July. 6 of 13 NewCos BioCentury ID'd are in I&I. Analysis by @fishburnsimone.bsky.social here: www.biocentury.com/article/654859

D.C. life: friends who are telling me this is the worst week of their career in the federal government, and it's going to get worse; and others who don't even want to put things in writing. These are not deep staters, they are people who just want to do science to make the world a better place.

Bloomberg is reporting that J&J is considering a bid for Intra-Cellular Therapeutics, whose market cap crossed the $10 billion after touching a 52-week high on Friday. ITCI has one marketed therapy, antipsychotic Caplyta lumateperone; most of the rest of its pipeline is CNS-focused as well.

Jami Rubin goes back to the finance sector - one of the best known biotech equity research analysts at Goldmans, she went into biotech at EQRx and Boundless Bio, (also was at PJT Partners, ARCH Ventures - so she knows a thing or two. www.guggenheimsecurities.com/about/news/p...

A postcard from the Australian Open, where I'm hopeful that Bounces can do some big things during its first major, and that it can be the first of many such trips with subscriber support. 🙏 www.benrothenberg.com/p/2025-austr...

My message for biotech entering 2025. Optimism is in short supply, replaced largely by exhaustion. So what are the options for over-delivering on expectations? www.biocentury.com/article/654609

Updated story on the #CagriSema Phase 3 data in #obesity for $NVO: www.biocentury.com/article/654546

CagriSema misses the mark in #obesity www.biocentury.com/article/654546

Bob Temple, who helped revolutionize the ways drugs are developed and regulated, is retiring from FDA after 52 years. I took a look at his legacy -- from blinded, controlled clinical trials to accelerated approval in today's BioCentury: www.biocentury.com/article/654528

Ottimo, led by former Seagen CEO David Epstein, has a bifunctional PD-1/VEGFR2, has a new $140m series A today, with OrbiMed, Avoro Capital and Samsara leading. It's from an internal project at Medicxi, my colleague Danielle Golovin writes:

Climb Bio CEO Aoife Brennan on how to navigate the biotech CEO paradox -- preparing for repeated setbacks while planning optimistically -- on the #BioCenturyShow with BioCentury Ed in Chief @fishburnsimone.bsky.social www.biocentury.com/article/654451 & wherever you pod

Thanks BioCentury, Karen Tkach Tuzman, and @fishburnsimone.bsky.social for this opportunity to discuss biomarkers, translational research, and our new Translational Medicine organization at Genentech / Roche www.biocentury.com/article/6541...

uniQure says it has alignment with FDA on a path to accelerated approval of its gene therapy for Huntington's disease. Composite UHDRS endpoint; using data from 51 pts across two ongoing studies + one add'l cohort, compared with natural history. Shares +87%: uniqure.gcs-web.com/news-release...

Gilead takes option for Tubulis ADC for $20m up front. Target undisclosed. $30m exercise fee, $415m milestones. www.businesswire.com/news/home/20... My colleague Danielle Golovin's story about how Tubulis' innovations could lead to reduced toxicity: www.biocentury.com/article/6525...

Look for Janux to move today. The 7 y.o. T cell I-O company has early data for its 1st clinical program, JANX007, in pre Pluvicto prostate cancer patients that has shares up nearly 70% in pre-market trading.

On BioCentury This Week, I talked about why RFK Jr, a crank who says FDA is corrupt and pharma is colluding with the CIA to poison Americans, wld be a disaster. And why the biopharma industry should oppose the nomination. Here: www.biocentury.com/article/654233 and fine purveyors of podcasts.

Biocentury podcast, includes commentary about Trump's choice for FDA Commissioner, Biosecure act: www.biocentury.com/article/654319 (and open.spotify.com/episode/3iI0... or podcasts.apple.com/us/podcast/b...). Also, my take on Marty Makary ($) www.biocentury.com/article/654324

The size of the #obesity market means pharmas will play a large role in manufacturing and market the next wave of #AOMs - which pharmas are in and which are out in challenging leaders $LLY and $NVO? www.biocentury.com/article/654168 $VKTX $GPCR $TERN $AZN $AMGN $ROG $XBI

Our latest podcast with @fishburnsimone.bsky.social and @steveusdin.bsky.social with me filling in for @jcranmer.bsky.social while he was watching his beloved @philadelphiaeagles.bsky.social in LA: www.biocentury.com/article/654319

Biotechs are now responsible for half the drugs brought over the finish line for approval (2022-24). That's up from 30% in 2014-16 Moreover, biotechs are fueling the rise in overall FDA approvals --> pie is getting bigger because more biotechs are going it alone. www.biocentury.com/article/654172

With GSK's Blenrep back under FDA review for 2L+ MM, here's my colleague Lauren Martz's piece about testing cancer drugs in earlier treatment settings where they may succeed -- even if they might have failed in later lines: www.biocentury.com/article/6542...

If you're in London tomorrow, BioCentury's Editor-in-Chief @fishburnsimone.bsky.social mentioned their event on Tuesday w/ Centerview Partners' E. Eric Tokat 2 discuss biotech M&A. They have a couple of spaces left if you'd like 2 attend. Always great events: www.linkedin.com/feed/update/... #biosky

The migration of MedTwitter, along with a large cohort of science journalists, to BlueSky is striking in its scale and rapidity. In a short time, this shift has effectively transformed BlueSky into the essential hub for breaking medical news and vibrant scientific discourse.

Kicking off London Life Sciences week anchored by the Jefferies London Healthcare conference with a good 5-0 win

What’s the cost of routinely testing new cancer drugs in the sickest patients? Missing out on some good ones that might work, argues Lauren Martz in BioCentury. www.biocentury.com/article/654200

So will EMA get a flood of applicants from FDA now? I’d think it good hiring opportunity.

A recent NYT piece on ARIA risk & APOE4 status in Alzheimer's trials suggested pharma companies had misled patients by not disclosing results. We don't normally respond to that kind of thing, but this one matters, and they got it wrong: via BioCentury. www.biocentury.com/article/654122

On the whole, I won't be posting about election fallout. But this analysis by Steve Usdin is important for biotech - what to expect, the good and the bad and the who knows? If you read one thing, read this. www.biocentury.com/article/654147

Even in an world that’s quite cohesive — the biotech ecosystem — there are a bunch of myths that each sector has about the other. They get in the way of progress, as players misread incentives. What are pharmas, biotechs & academia getting wrong about each other? www.biocentury.com/article/6540...

I’m going to get through a ton of books the next 4 years with all the news and media I’m not going to obsess over.

So often I hear, “my vote doesn’t make a difference- I’m in a blue/red state.” Not true. The Iowa poll shows that. States change when people turn up. Don’t leave your fate - or democracy - to others. Vote

Lots of Alzheimer's discussion on this week's BioCentury podcast, plus some election talk (if you haven't had enough already) and the state of China's biotech market. Here, or wherever you enjoy podcasts: www.biocentury.com/article/6540...

On the eve of the election, barricades are being put up in DC next to govt buildings. This is where we’re at. Do other western democracies do this? Vote for the not chaos candidate.

Early reports on Alzheimer’s drugs are encouraging, but were not out of the woods yet, writes Selina Koch in BioCentury www.biocentury.com/article/6540...

FDA oncology chief Richard Pazdur has been a major force behind the surge of innovative cancer drugs, partly by saying no to incremental tx years ago. Steve Usdin (BioCentury) talked to him about that and more. www.biocentury.com/article/654022

By the way, below is BioCentury's Editor-in-Chief & Vice President who recently joined Bluesky #biosky

What would FDA look like under Trump? Some (Dem and GOP) stakeholders are very concerned that Trump's favor of RFK Jr. could take the agency in a dangerous direction. Others say, Oh that's just Trump. (no comment...). My colleague Steve Usdin reports in BioCentury: www.biocentury.com/article/653997

Just landed here at Bluesky, and the rest of my posts won't be like this first one. My message: VOTE. Vote like it matters, because it does. Get other people to vote. And most of all, take your kids to vote. Not less important than soccer practice, baseball games or Halloween. Vote.