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Another missed deadline by RFK Jr. & Makary's FDA -- this time for a treatment for a very rare disease: www.biocentury.com/article/655776

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Dear Canada- Please accept our deepest apologies from all decent Americans embarrassed by the obnoxious trolling from our man-baby-in-chief who is lacking in both intelligence & any impulse-control whatsoever. ❤️ from your neighbors below, 🇺🇸 #MakeAmericaNormalAgain

submitted 1 day ago • 1769 comments

And now, a note on Bill Owens who, until this past week, was the executive producer of 60 Minutes. We’ll be back next week with another edition of 60 Minutes.

submitted 2 days ago • 1370 comments

At last, a biotech buy that crosses $1B

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A few words on this morning's Merck KGaA/SpringWorks deal: Two rare tumor treatments, a takeout consummated after months of rumors, and relief from an M&A drought: www.biocentury.com/article/6557...

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Hong Kong exchange seizes the moment: Growing momentum at the Hong Kong stock exchange and chaotic policies from the White House may upend the longstanding IPO calculus for Asia’s biotechs. Here's my take in BioCentury: www.biocentury.com/article/655670

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#AACR25 Preview: Bispecific antibodies, targeted protein degraders are front and center at this year’s meeting, driving modality innovation, while post-translational sugar modifications are emerging as a focal point for new target discovery via BioCentury: www.biocentury.com/article/655676

submitted 5 days ago • 0 comments

Two key management moves at Galapagos: - CEO Paul Stoffels (ex-JNJ CSO) is retiring this year, but will remain chairman - Ex-Neumora CEO Henry Gosebruch will be CEO of the planned GLPG spinout Release: www.globenewswire.com/news-release... Background ($): www.biocentury.com/article/6546...

submitted 8 days ago • 0 comments

I just landed in San Salvador a little while ago, and I look forward to meeting with the team at the U.S. embassy to discuss the release of Mr. Abrego Garcia. I also hope to meet with Salvadoran officials and with Kilmar himself. He was illegally abducted and needs to come home.

submitted 14 days ago • 2939 comments

Makary filling key #FDA spots with Capitol Hill alum Grace Graham, Washington lawyer Lowell Zeta, BioCentury's @steveusdin.bsky.social has learned. They'll join the agency's Office of the Commissioner

submitted 13 days ago • 0 comments

Shanghai ADC play Duality braved one of HK's worst downturns of past 20 yrs to stick its landing on the HKSE, offering hope to China biotechs that have been suffering through a multiyear financing drought. I took a closer look in today's BioCentury www.biocentury.com/article/655632

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"Not exactly a pick-me-up" said my BioCentury pal Josh Berlin about this week's BioCentury This Week biotech podcast! But trust him, it's the stuff you know you need to know about what's happening at FDA -- and to the XBI: www.biocentury.com/article/655488

submitted 28 days ago • 0 comments

Just after biotech started to see some green shoots, we're back in a bear market. $XBI cratering in the wake of Peter Marks departure from FDA, looming tariff threat. #FAFO

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here's a short window left to halt the brain drain at FDA,says BioCentury's @steveusdin.bsky.social Senior managers, office directors, and reviewers with decades of experience have accepted or plan to accept buyout offers. Anxiety is high in White Oaks. www.biocentury.com/article/655391

submitted 42 days ago • 0 comments

Shares of WuXi AppTec and WuXi Biologics are closing in on pre-Biosecure Act levels now that the legislation that sought to rein in China CDMOs and genomics companies appears to have faded away. Read my latest in BioCentury: www.biocentury.com/article/655397

submitted 42 days ago • 0 comments

Congress is considering a House bill that would eliminate a huge incentive for pediatric drug development, slash funding for innovative biomedical research & give RFK Jr. authority to implement his agenda w/o Congressional consent, writes @steveusdin.bsky.social www.biocentury.com/article/655338

submitted 48 days ago • 0 comments

My latest on the #Zealand and #Roche deal for amylin agonist pretrelintide: www.biocentury.com/article/655330

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RFK Jr. Vows To Make Measles Deaths So Common They Won’t Be Upsetting Anymore

submitted 61 days ago • 479 comments

Morale at FDA is sinking as news of firings, dubbed a Valentine’s Day massacre by agency staff, started ricocheting from Reddit threads and social media posts to group text chats and phone calls Friday evening, writes @steveusdin.bsky.social www.biocentury.com/article/655114

submitted 71 days ago • 0 comments

Here is the pre-RFK vaccination schedule for your kids. Please download it before he is confirmed and changes/deletes it. Give it to your pediatrician and say this is the schedule you want your kids on. Making this my pinned post.

submitted 84 days ago • 96 comments

Especially shocking because diversity of clinical trials is squarely a scientific necessity if the results are to be representative of and generalizable to the broader population. It's bad science to test a candidate medicine in a non-representative population.

submitted 75 days ago • 1 comment

DISEASES ERADICATED OR DECIMATED BY SCIENCE: 1. Chickenpox 2. Diphtheria 3. Measles 4. Pertussis 5. Pneumococcal Infection 6. Polio 7. Tetanus 8. Typhoid 9. Yellow Fever 10. Smallpox DISEASES ERADICATED OR DECIMATED BY RFK JR. OR PRAYER: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

submitted 76 days ago • 1225 comments

Imagine if @aoc @sanders.senate.gov , every dem, SIMULTANEOUSLY held Town Halls where they allowed grant and contract recipients to explain to the country what it is they do and why it's important Invite all media. Including RW podcasters. @spaces Flood the zone Call it a Day Of Transparency

submitted 77 days ago • 3831 comments

BREAKING: In response to doctors' lawsuit, Judge John Bates, a George W. Bush appointee, orders CDC, NIH, and FDA to put back up websites and datasets cited by the doctors in their lawsuit as having been relied upon and pulled down without notice. storage.courtlistener.com/recap/gov.us...

submitted 78 days ago • 303 comments

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.

submitted 78 days ago • 0 comments

I wonder if Georgia residents @bluestein.bsky.social @ajc.com saw the news re: draft executive order to "eliminate CDC" according to sources who spoke with @biocentury.bsky.social. See story below please #medsky #biosky

submitted 81 days ago • 0 comments

White House plans to slash FDA, NIH, eliminate CDC could create lasting damage to public health, sink biopharma stocks, and cede scientific leadership to China, individuals briefed on the plans by White House officials told BioCentury's @steveusdin.bsky.social www.biocentury.com/article/655011

submitted 82 days ago • 0 comments

Biopharma Wake-up Call: Defending NIH, NSF & the foundation of U.S. science. There is an assault on U.S. science and silence is not an option, argue Luke Evnin, Peter Rubin and Peter Kolchinsky in a BioCentury Op-Edhttps://www.biocentury.com/article/654982

submitted 83 days ago • 0 comments

ElevAAte Biotech aims to overcome C-suite underrepresentation by mentoring U.S. biopharma leaders of East Asian descent. Its co-founders: investors Lorence Kim, Bong Koh, Chen Yu, execs June Lee, Ken Song, Angie You, & banker Matt Kim. Read more in BioCentury: www.biocentury.com/article/654632

submitted 83 days ago • 0 comments

Go Birds 🦅 Just a few more days …

submitted 84 days ago • 1 comment

FDA places a Phase 1 study of Amgen's AMG 513 for obesity on clinical hold. "Discussions are underway on a path forward to reopen the study." h/t @biobonanos.bsky.social

submitted 84 days ago • 0 comments

In BioCentury's 2nd story in our multipart look at Asia's NewCo Model, we focus on the VC angle. Investors with deep China roots like LAV & Orbimed have helped lead the surge, inspiring Western VCs to jump in. 50+ investors have invested in 13 NewCos www.biocentury.com/article/654907

submitted 85 days ago • 0 comments

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

submitted 90 days ago • 0 comments

In 1970- GOP president declared a "war on cancer" & sought additional funding for cancer research. In '71, he signed the National Cancer Act into law. In 2025—GOP president launches a war on cancer patients (& HIV patients-see PEPFAR news). GOP cuts funding & grants for cancer #medsky #biosky ⬇️

submitted 92 days ago • 1 comment

Metsera and Maze have each proposed IPO terms. Could trade this week. Metsera: 17.2m shares @ $15-$17; at midpoint, would raise $275m at $1.7b valuation Maze: 7.8m @ $15-$17; midpoint would raise ~$125m @ $780m @jcranmer.bsky.social's story from 10 Jan: www.biocentury.com/article/6546...

submitted 93 days ago • 1 comment

Project Community is the latest FDA initiative to be disappeared by Trump 2.0. It launched to provide resources for “patients living with cancer, survivors, advocates, families, and people living in underserved urban and rural communities who are at greater cancer risk.”

submitted 92 days ago • 0 comments

In a listing that raised nearly $130M, Suzhou-based Ascentage became the 1st biotech to initially list on the Hong Kong stock exchange’s biotech chapter and subsequently conduct a NASDAQ offering. h/t @biobonanos.bsky.social

submitted 95 days ago • 0 comments

For most of this week FDA staff didn’t know who was running the store. In a late Friday website change, Sara Brenner’s title switched from principal deputy commissioner to acting commissioner. Previously, she held a low profile position as CMO for IVDs & assoc director for med affairs at CDRH

submitted 95 days ago • 0 comments

Worries beginning to mount in biotech that Trump’s communications freeze, DEI policies could impact drug development. @steveusdin.bsky.social details changes at FDA that could slow innovation: www.biocentury.com/article/654795

submitted 96 days ago • 0 comments

Looking to catch up on the buzz at JPMorgan in SF? Tune into the BioCentury This Week podcast wherever you get your pods. @steveusdin.bsky.social breaks down the latest in Washington as we lurch toward Trump 2.0. @stephenhansen.bsky.social breaks down the deals. www.biocentury.com/article/654694

submitted 106 days ago • 0 comments

. BIO CEO Crowley to meet with Trump at Mar-a-Lago this weekend to discuss options for reforming FDA reports @steveusdin.bsky.social. Steve says incoming admin plans to create an advisory body that will make specific recommendations for modernizing FDA; Crowley will have a seat

submitted 109 days ago • 0 comments

Well-funded obesity play Metsera has filed for IPO. The 2 yr old NYC biotech, which has raised $500M+ in venture $ from Arch, F-Prime, Mubadala, GV, Softbank & more, expects Ph 2 data in 1H25 from 1x monthly injectable GLP-1 agonist. The founding team includes several former Medicines Co. leaders

submitted 109 days ago • 0 comments