Jeff Cranmer

A leaked memo on BIO's strategy is energizing anti-vaxxers, writes BioCentury's @steveusdin.bsky.social. The document describes BIO's investment in pro-vaccine communications, plans to engage with conservatives in and outside the Trump administration

Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER, reports @steveusdin.bsky.social

Industry races to counter Trump MFN threat Biopharma leaders view President Donald Trump’s push for “most favored nation” drug pricing as a serious, urgent threat. While there i...

The biopharma industry is racing to counter the Trump MFN threat: With White House demanding 85% across-the-board drug price cuts, the biopharma industry hopes to avoid catastrophic policies via alternative concessions, writes @steveusdin.bsky.social in BioCentury www.biocentury.com/article/656077

Stealth CRL raises questions about FDA’s implementation of rare disease policies FDA has issued a complete response letter for elamipretide, sending patients with Barth syndrome, along with the drug’s developer, Stealth Biotherap...

Setback for Stealth raises questions about FDA’s implementation of rare disease policies. The biotech’s regulatory odyssey in Barth syndrome exemplifies the problems Makary has vowed to fix. @steveusdin.bsky.social Usdin takes a closer look in BioCentury: www.biocentury.com/article/656066

In biggest licensing deal yet for a China asset, Pfizer takes rights to 3SBio’s bispecific In the latest and largest deal between a China-based biotech and a larger biopharma for a bispecific with broad potential in oncology, Pfizer is paying 3SB...

Biggest licensing deal yet for a China biotech asset-PFE taking rights to 3SBio bispecific-is also tied for 3rd largest asset deal ever in biotech.

This latest deal in the PD-(L)1 x VEGF space has PFE paying $1.25B u/f. Here's @biobonanos.bsky.social take www.biocentury.com/article/655979

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...

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

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

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.

At last, a biotech buy that crosses $1B

Eight-year-run for Pfizer spinout Springworks culminates in Merck KGaA buyout The takeout of Springworks by Merck KGaA will fortify the German company’s oncology business with a pair of approved drugs for rare tumors, while al...

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...

Hong Kong exchange seizes the moment: a Perspective Growing momentum at the Hong Kong stock exchange and chaotic policies from the White House may upend the longstanding IPO calculus for Asia’s biotec...

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

Degraders, bispecifics define translational trends at AACR Bispecific antibodies and targeted protein degraders are front and center at this year’s AACR Annual Meeting, driving modality innovation, while pos...

#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

Makeover for Gilead-Galapagos deal to yield newco primed for BD What has become of Galapagos a little more than five years after its major partnership with Gilead is far from what the partners had envisioned for the meg...

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...

YouTube video by Senator Chris Van Hollen Just landed in El Salvador to discuss release of Kilmar Abrego Garcia

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.

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

Days after Hong Kong tumbles, ADC play Duality braves IPO Shanghai ADC play Duality braved one of Hong Kong’s worst downturns of the past 20 years to stick its landing on the Stock Exchange of Hong Kong, of...

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

The bear is back: Marks’ ouster, tariffs and a tumbling XBI: a BioCentury podcast Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary Robert F. Kennedy Jr. and the threat of tariffs...

"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

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

Short window to halt FDA brain drain Marty Makary is on track for Senate confirmation as FDA commissioner as soon as next week, but he’ll have little time for celebration. His immediate...

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

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

House spending bill omits PRV reauthorization, slashes biomedical research program With Congress facing a Friday deadline to pass legislation to avoid a government shutdown, lawmakers are considering a bill passed by the House that would ...

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

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

RFK Jr. Vows To Make Measles Deaths So Common They Won’t Be Upsetting Anymore WASHINGTON—Addressing the ongoing outbreak in Texas that has infected at least 124 state residents and killed one child, Health and Human Services Secretary Robert F. Kennedy Jr. vowed Thursday to mak...

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

First round of cuts torpedos FDA morale, more firings expected 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 m...

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

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.

Also, while the FDA of the next 4 yrs may not care, the FDA of the future may care once more. And how many pivotal trials being started now will have a PDUFA date within 4 years? Probably not the vast majority

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.

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.

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

Help Denmark Buy California – Because Why Not? Buy it from Trump, the bigliest crowdsourcing ever

On the bright side -- in case my plans to form a new nation stretching from Alaska through B.C. to Cali and Cabo fail -- we always have this option: denmarkification.com