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...
I will be watching for it
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, 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:
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.
