Simone Fishburn

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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 FDA has missed another PDUFA review deadline, this time for a treatment that a small biotech is developing for an ultrarare disease. Stealth Biotherapeutic...

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...

YouTube video by BioCentury Video Ep. 80 - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs

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...

With Medicxi’s backing, Curevo takes aim at Shingrix with $110M series B With a new $110 million series B led by Medicxi, Seattle-based Curevo is moving a potential competitor to blockbuster shingles vaccine Shingrix toward...

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...

I will be watching for it

Embrace the competition from China, says Maraganore The rising competition from China is to be welcomed not feared, says John Maraganore, who argues the innovation will push biotechs globally to greater...

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.

Crippling NIH is handing China a huge advantage: a Perspective It’s arguable as to whether the chaos around the executive orders this week in which NIH has been swept up is a feature or a bug of the Trump admini...

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 boom signals China’s galloping speed of innovation If anyone still doubts the competitiveness of China biotechs in innovation and dealmaking, the boom of companies founded on the so-called “NewCo Mod...

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.

Guggenheim Securities Hires Jami Rubin to Expand Healthcare Investment Banking Practice Guggenheim Securities announced today that Jami Rubin will join the firm’s healthcare investment banking practice as a Senior Managing Director.

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 New G'day, From Melbourne On the ground for Bounces' first major trip: the 2025 Australian Open.

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...

Letter from the Editor: Untangling reality and expectations in 2025 Optimism appears to be in short supply entering 2025, replaced largely by exhaustion. So what are the options for making 2025 over-deliver on expectations?...

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

Novo’s market cap slims down on CagriSema obesity data Novo Nordisk received a lump of coal in its stocking this season. It arrived in the form of Phase III data for its most important weight loss candidate, Ca...

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

CagriSema misses the mark in obesity Novo Nordisk has received a lump of coal in its stocking this season. It arrived in the form of Phase III data for its most important weight loss candidate...

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

Bob Temple, father of modern FDA, set to retire Robert “Bob” Temple, who helped revolutionize the ways medical products are developed and regulated, is retiring from FDA after 52 years at t...

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, which emerged from stealth in October, was co-founded by Medicxi and antibody engineer Jonny Finlay. Epstein said Finlay came up with the idea years ago at a group within Medicxi called UltraHuman, which is dedicated to developing best-in-class immuno-oncology antibodies. “He worked on it for about four or five years, but then they didn’t really know what to do with it. And then the Summit data came out,” said Epstein.

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:

Only the paranoid survive, and the CEO’s paradox, from Aoife Brennan Leading companies through the turbulence of the past few years and the uncertainty of the next ones takes not just resilience, but an ability to grapp...

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

Learning human biology: a Q&A with Genentech’s Nikhil Wagle The growing ability to learn from patient samples begets the responsibility to do so, according to Gentech’s SVP and Global Head of Translational Me...

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...

Tubulis: Enhancing ADC stability via new conjugation methods Tubulis is innovating on the linker, payload and drug-to-antibody ratio of antibody-drug conjugates, with a modular platform that optimizes for ADC stabili...

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.

RFK Jr. & HHS, Blenrep’s comeback, China deals: a BioCentury podcast Giving Robert F. Kennedy Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding...

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.

Jefferies recap, FDA commissioner & Biosecure update: a BioCentury podcast Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that lies ahead as a result of the U.S...

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

Pharmas challenging Novo and Lilly in obesity Eli Lilly and Novo Nordisk have clearly set themselves apart from other pharmas in the scale of their pipelines, revenues and business development activiti...

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