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Simone Fishburn

@fishburnsimone.bsky.social
201 followers 129 following 25 posts

Biotech, Brit ex-pat, tennis enthusiast, scientist, editor, women in leadership - not in order of priority

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Simone Fishburn @fishburnsimone.bsky.social · 01/05/2025
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...
biocentury.com
U.S. Political Developments Snap Survey | BioCentury
Discover key insights from BioCentury’s survey on U.S. political developments. Explore industry sentiment, top concerns and download the full report for in-depth analysis.
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steveusdin.bsky.social @steveusdin.bsky.social · 29/04/2025
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
biocentury.com
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...
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Simone Fishburn @fishburnsimone.bsky.social · 18/04/2025
Results out later today! Stay tuned...
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Simone Fishburn @fishburnsimone.bsky.social · 27/03/2025
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...
youtube.com
Ep. 80 - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs
YouTube video by BioCentury Video
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Paul Bonanos @biobonanos.bsky.social · 17/03/2025
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...
biocentury.com
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...
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Simone Fishburn @fishburnsimone.bsky.social · 21/02/2025
I will be watching for it
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Simone Fishburn @fishburnsimone.bsky.social · 14/02/2025
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
biocentury.com
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...
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Jeff Cranmer @jcranmer.bsky.social · 11/02/2025
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.
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Scott Gottlieb, MD @scottgottliebmd.bsky.social · 31/01/2025
statesman.com
Measles is back in Texas with two cases in Houston. Here's what you need to know.
Two Houston measles cases have public health officials worried about possible outbreak.
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Simone Fishburn @fishburnsimone.bsky.social · 31/01/2025
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
biocentury.com
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...
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Simone Fishburn @fishburnsimone.bsky.social · 30/01/2025
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
biocentury.com
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...
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Jeff Cranmer @jcranmer.bsky.social · 29/01/2025
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
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Simone Fishburn @fishburnsimone.bsky.social · 24/01/2025
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.
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Paul Bonanos @biobonanos.bsky.social · 12/01/2025
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.
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Simone Fishburn @fishburnsimone.bsky.social · 10/01/2025
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...
guggenheimsecurities.com
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.
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Ben Rothenberg @benrothenberg.bsky.social · 06/01/2025
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...
benrothenberg.com
A New G'day, From Melbourne
On the ground for Bounces' first major trip: the 2025 Australian Open.
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Simone Fishburn @fishburnsimone.bsky.social · 04/01/2025
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
biocentury.com
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?...
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Stephen Hansen @stephenhansen.bsky.social · 21/12/2024
Updated story on the #CagriSema Phase 3 data in #obesity for $NVO: www.biocentury.com/article/654546
biocentury.com
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...
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Stephen Hansen @stephenhansen.bsky.social · 20/12/2024
CagriSema misses the mark in #obesity www.biocentury.com/article/654546
biocentury.com
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...
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Jeff Cranmer @jcranmer.bsky.social · 20/12/2024
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
biocentury.com
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...
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Paul Bonanos @biobonanos.bsky.social · 19/12/2024
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:
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.
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Jeff Cranmer @jcranmer.bsky.social · 13/12/2024
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
biocentury.com
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...
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Nikhil Wagle, MD @nikhilwagle.bsky.social · 11/12/2024
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...
biocentury.com
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...
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Paul Bonanos @biobonanos.bsky.social · 10/12/2024
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.gcs-web.com
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.
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Paul Bonanos @biobonanos.bsky.social · 03/12/2024
Gilead takes option for Tubulis ADC for $20m up front. Target undisclosed. $30m exercise fee, $415m milestones. www.businesswire.com/news/home/20... My colleague Danielle Golovin's story about how Tubulis' innovations could lead to reduced toxicity: www.biocentury.com/article/6525...
biocentury.com
Tubulis: Enhancing ADC stability via new conjugation methods
Tubulis is innovating on the linker, payload and drug-to-antibody ratio of antibody-drug conjugates, with a modular platform that optimizes for ADC stabili...
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Jeff Cranmer @jcranmer.bsky.social · 03/12/2024
Look for Janux to move today. The 7 y.o. T cell I-O company has early data for its 1st clinical program, JANX007, in pre Pluvicto prostate cancer patients that has shares up nearly 70% in pre-market trading.
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steveusdin.bsky.social @steveusdin.bsky.social · 19/11/2024
On BioCentury This Week, I talked about why RFK Jr, a crank who says FDA is corrupt and pharma is colluding with the CIA to poison Americans, wld be a disaster. And why the biopharma industry should oppose the nomination. Here: www.biocentury.com/article/654233 and fine purveyors of podcasts.
biocentury.com
RFK Jr. & HHS, Blenrep’s comeback, China deals: a BioCentury podcast
Giving Robert F. Kennedy Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding...
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steveusdin.bsky.social @steveusdin.bsky.social · 27/11/2024
Biocentury podcast, includes commentary about Trump's choice for FDA Commissioner, Biosecure act: www.biocentury.com/article/654319 (and open.spotify.com/episode/3iI0... or podcasts.apple.com/us/podcast/b...). Also, my take on Marty Makary ($) www.biocentury.com/article/654324
biocentury.com
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...
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Stephen Hansen @stephenhansen.bsky.social · 28/11/2024
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
biocentury.com
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...
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Stephen Hansen @stephenhansen.bsky.social · 26/11/2024
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
biocentury.com
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...
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Simone Fishburn @fishburnsimone.bsky.social · 25/11/2024
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
biocentury.com
Biotechs now match pharma for FDA approvals
Biotechs are shedding their reliance on pharma to get drugs across the finish line for approval, with half the FDA approved drugs now being taken the whole...
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Paul Bonanos @biobonanos.bsky.social · 25/11/2024
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...
biocentury.com
Blenrep comeback makes the case for early-first cancer approach: a Perspective
There’s an unspoken rule that cancer drugs should be tested in the sickest patients first. It’s time to turn that paradigm on its head.&...
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Pearl Freier @pearlf.bsky.social · 18/11/2024
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
linkedin.com
Simone Fishburn on LinkedIn: Great to be in London for London Life Sciences Week anchored by the…
Great to be in London for London Life Sciences Week anchored by the Jefferies London Healthcare conference. Join us at the BioCentury Inc.-BioIndustry…
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Scott Gottlieb, MD @scottgottliebmd.bsky.social · 17/11/2024
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.
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Simone Fishburn @fishburnsimone.bsky.social · 17/11/2024
Kicking off London Life Sciences week anchored by the Jefferies London Healthcare conference with a good 5-0 win
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Simone Fishburn @fishburnsimone.bsky.social · 17/11/2024
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
biocentury.com
Blenrep comeback makes the case for early-first cancer approach: a Perspective
There’s an unspoken rule that cancer drugs should be tested in the sickest patients first. It’s time to turn that paradigm on its head.&...
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Simone Fishburn @fishburnsimone.bsky.social · 14/11/2024
So will EMA get a flood of applicants from FDA now? I’d think it good hiring opportunity.
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Simone Fishburn @fishburnsimone.bsky.social · 11/11/2024
If you want a "what was known when" about ARIA, APOE4 and Alzheimer's, read Selina Koch's story with a timeline. These decisions were made before the link was known. And knowing the status skews results. The picture evolved over the last few years, she shows. www.biocentury.com/article/654127
biocentury.com
The evolving picture of ARIA risk and APOE4 status in Alzheimer’s
As the amyloid field has settled the debate about efficacy that raged for two decades or more, it finds itself now needing to manage that efficacy against ...
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Simone Fishburn @fishburnsimone.bsky.social · 11/11/2024
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
biocentury.com
The ethics of Alzheimer's trials: more to the story
New York Times reporters have trained a retrospectroscope onto Alzheimer’s disease trials and concluded that drug companies and academic researchers...
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Simone Fishburn @fishburnsimone.bsky.social · 11/11/2024
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
biocentury.com
Prepping for Trump
 The new political reality in Washington presents opportunities, threats and a lot of food for thought for leaders of industries like biopharma that n...
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Simone Fishburn @fishburnsimone.bsky.social · 07/11/2024
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...
biocentury.com
Myths and misperceptions — industry’s stumbling blocks
Our industry is rife with myths that shape its sectors’ perceptions of each other. The cost is that it slows down, impairs, or even prevents th...
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Simone Fishburn @fishburnsimone.bsky.social · 06/11/2024
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.
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Simone Fishburn @fishburnsimone.bsky.social · 05/11/2024
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
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Paul Bonanos @biobonanos.bsky.social · 05/11/2024
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...
biocentury.com
Alzheimer insights: Anti-amyloid safety and tau takeaways, a BioCentury podcast
It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encour...
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Simone Fishburn @fishburnsimone.bsky.social · 04/11/2024
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.
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Simone Fishburn @fishburnsimone.bsky.social · 04/11/2024
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...
biocentury.com
Not out of the woods yet for Alzheimer’s mAbs: a Perspective
Alzheimer’s therapy Leqembi is being used according to its label and without a spike in adverse events over the rates observed in clinical trials, a...
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Simone Fishburn @fishburnsimone.bsky.social · 31/10/2024
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
biocentury.com
How FDA could learn from oncology
Over the last two decades, scientific discoveries have propelled a surge in cancer drug development, but progress in bringing new medicines to patients has...
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Pearl Freier @pearlf.bsky.social · 31/10/2024
By the way, below is BioCentury's Editor-in-Chief & Vice President who recently joined Bluesky #biosky
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Simone Fishburn @fishburnsimone.bsky.social · 29/10/2024
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
biocentury.com
Trump’s remarks stoke fears about FDA leadership
Former President Donald Trump’s embrace of Robert F. Kennedy Jr. has sparked concerns in the biopharma industry over the politicization of public he...
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