Simone Fishburn
@fishburnsimone.bsky.social
Biotech, Brit ex-pat, tennis enthusiast, scientist, editor, women in leadership - not in order of priority
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...
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...
May 1, 2025 at 1:53 PM
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...
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...
Reposted by Simone Fishburn
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
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
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...
www.biocentury.com
April 29, 2025 at 12:36 PM
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
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...
An anonymous survey from the BioCentury folks on biopharma sentiment about the Trump administration so far. I just took it myself:
www.surveymonkey.com/r/VWMPWMC
www.surveymonkey.com/r/VWMPWMC
April 2025 Sentiment Survey
BioCentury survey on biopharma industry sentiment about recent U.S. political developments.
www.surveymonkey.com
April 18, 2025 at 1:54 PM
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...
www.youtube.com/watch?v=Zwqn...
Ep. 80 - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs
YouTube video by BioCentury Video
www.youtube.com
March 27, 2025 at 1:32 PM
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...
www.youtube.com/watch?v=Zwqn...
Reposted by Simone Fishburn
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...
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...
www.biocentury.com
March 17, 2025 at 12:15 PM
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
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...
www.biocentury.com
February 14, 2025 at 9:23 PM
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
Reposted by Simone Fishburn
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.
February 11, 2025 at 3:05 PM
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.
Reposted by Simone Fishburn
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
www.biocentury.com/article/654890
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...
www.biocentury.com
January 31, 2025 at 12:59 PM
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
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
www.biocentury.com/article/654859
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...
www.biocentury.com
January 30, 2025 at 10:05 PM
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
www.biocentury.com/article/654859
Reposted by Simone Fishburn
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
January 29, 2025 at 6:57 PM
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.
January 24, 2025 at 11:42 PM
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.
Reposted by Simone Fishburn
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.
January 12, 2025 at 11:21 PM
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...
www.guggenheimsecurities.com/about/news/p...
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.
www.guggenheimsecurities.com
January 10, 2025 at 4:35 PM
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...
www.guggenheimsecurities.com/about/news/p...
Reposted by Simone Fishburn
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...
www.benrothenberg.com/p/2025-austr...
A New G'day, From Melbourne
On the ground for Bounces' first major trip: the 2025 Australian Open.
www.benrothenberg.com
January 6, 2025 at 1:03 AM
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...
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
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?...
www.biocentury.com
January 4, 2025 at 1:31 PM
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
Reposted by Simone Fishburn
Updated story on the #CagriSema Phase 3 data in #obesity for $NVO: www.biocentury.com/article/654546
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...
www.biocentury.com
December 21, 2024 at 2:08 AM
Updated story on the #CagriSema Phase 3 data in #obesity for $NVO: www.biocentury.com/article/654546
Reposted by Simone Fishburn
CagriSema misses the mark in #obesity 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...
www.biocentury.com
December 20, 2024 at 1:39 PM
CagriSema misses the mark in #obesity www.biocentury.com/article/654546
Reposted by Simone Fishburn
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
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...
www.biocentury.com
December 20, 2024 at 2:41 AM
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
Reposted by Simone Fishburn
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:
December 19, 2024 at 12:36 PM
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:
Reposted by Simone Fishburn
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
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...
www.biocentury.com
December 13, 2024 at 1:33 AM
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
Reposted by Simone Fishburn
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...
www.biocentury.com/article/6541...
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...
www.biocentury.com
December 11, 2024 at 3:14 PM
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...
www.biocentury.com/article/6541...
Reposted by Simone Fishburn
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...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease | uniqure BV
The Investor Relations website contains information about uniqure BV's business for stockholders, potential investors, and financial analysts.
uniqure.gcs-web.com
December 10, 2024 at 1:04 PM
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...
Reposted by Simone Fishburn
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...
My colleague Danielle Golovin's story about how Tubulis' innovations could lead to reduced toxicity: www.biocentury.com/article/6525...
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...
www.biocentury.com
December 3, 2024 at 1:05 PM
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...
My colleague Danielle Golovin's story about how Tubulis' innovations could lead to reduced toxicity: www.biocentury.com/article/6525...