
What do a government shutdown, a global conference in Singapore, and a quarter-million-dollar travel bill have in common? Apparently, the FDA.
Internal records show 31 FDA staffers flew to Singapore in mid-November for an international regulatory conference, with the tab topping $250,000 or more than $8,000 per person. The timing raised eyebrows: the trip was approved while the agency was operating with reduced staffing and limited resources due to the shutdown, plus it was approved just one week before the shutdown ended.
The FDA says the travel was “mission critical,” pointing to the importance of global alignment on drug development and regulatory standards. Critics, meanwhile, are asking a simpler question: mission critical… was it though?
📰 Headliners

💰 Chai Discovery Brews a $1.3B Valuation.
Less than six months after its Series A, AI drug developer Chai Discovery raised a $130 million Series B, cementing unicorn status at a $1.3 billion valuation. The raise underscores continued investor enthusiasm for computer-aided drug design, even as questions linger about which AI platforms will translate hype into durable pipelines.
⚖️ FDA Fast-Tracks J&J’s Myeloma Combo.
Johnson & Johnson received a coveted Commissioner’s National Priority Voucher for its Tecvayli–Darzalex combination in previously treated multiple myeloma. The voucher could shrink FDA review timelines from 10 months to as little as one to two, signaling the agency’s willingness to accelerate therapies addressing serious unmet needs.
💰 Sobi Snaps Up Arthrosi in a $1.5B Gout Bet.
Fresh off a $153M Series E, Arthrosi Therapeutics agreed to be acquired by Sobi in a deal worth up to $1.5 billion, including $950 million upfront. The acquisition gives Sobi control of pozdeutinurad, a once-daily oral gout therapy positioned to improve efficacy and tolerability in a crowded market.
🧠 Sanofi’s MS Program Takes a Double Hit.
Sanofi’s tolebrutinib failed to slow disability progression in a Phase III multiple sclerosis trial, while regulators delayed an approval decision in progressive disease once again. The paired setbacks highlight how unforgiving late-stage neurology programs remain, even for pharma heavyweights.
⚖️ Zealand Wants to Take Obesity Drugs Straight to the Brain.
Zealand Pharma is seeking partners to develop obesity therapies that act directly in the brain, aiming for better efficacy and fewer side effects. As GLP-1 competition heats up, differentiation is shifting from “how much weight?” to “how does it work?”
💰 Sanofi Deepens Its Bet on Dren Bio.
Sanofi expanded its collaboration with Dren Bio in a deal worth up to $1.7 billion, including $100 million upfront. The partnership centers on Dren’s targeted myeloid engager platform to develop next-gen autoimmune therapies. Translation: Sanofi is betting big on precision immune cell clearance.
💉 Amgen’s Uplizna Enters the Myasthenia Gravis Market.
The FDA approved Amgen’s Uplizna for adults with generalized myasthenia gravis who are AChR or MuSK antibody positive. It’s a competitive space, but Amgen clearly sees room for differentiated biologics with durable efficacy.
⚡️ Quick Hits
Immunome — Phase III desmoid tumor data slashed progression risk by 84%, sending shares up 25%. Analysts called it a near best-case outcome.
Arcus Biosciences and Gilead — A late-stage trial of their anti-TIGIT antibody domvanalimab has flopped, prompting an R&D reset for Arcus and fewer shots on goal.
Rezolute — Shares cratered 87% (gulp) after their pivotal hypoglycemia drug disappointed in a phase III trial. Biotech giveth and taketh away.
Medline — Set terms for a $5.37B IPO, potentially the largest U.S. offering of 2025. The company goes public this week.
Kyverna Therapeutics — Plans to seek approval for what could become the first marketed cell therapy for an autoimmune disease.
GSK & Innoviva — The FDA cleared two first-in-class oral gonorrhea treatments in back-to-back days, ending a 30-year antibiotic drought for the disease… big day for gonorrhea. 😳
AC Immune — Posted encouraging Parkinson’s immunotherapy data and may accelerate regulatory talks.
🧐 Deep Dive

Measles Makes an Unwelcome Comeback
Measles was declared eliminated in the U.S. in 2000.
Fast-forward to now: People aren’t buying CD’s, there’s only one remaining Blockbuster store (thanks Netflix), and public health officials are dealing with outbreaks that feel ripped from a much older playbook.
South Carolina’s outbreak is accelerating, with 111 confirmed cases since October and 250+ people quarantined. The most sobering detail: 105 of those infected were unvaccinated. Officials say vaccination rates were “lower than hoped for,” a phrase doing a lot of heavy lifting.
Most of the infected in SC are school aged children from elementary to high school. According to the state epidemiologist, many of these new cases stemmed from the local Way of Truth Church in Inman, SC. The church is reportedly actively working with health officials to prevent further transmission.
It’s not just South Carolina. Similar outbreaks have surfaced in Texas, Oklahoma, New Mexico, Utah, and Arizona, raising alarms among epidemiologists. Measles remains one of the most contagious viruses known, and when vaccination coverage dips, it wastes no time exploiting the gap.
The takeaway isn’t subtle. Elimination doesn’t mean extinction, and public health gains aren’t permanent without sustained trust, access, and uptake. Simply put, prevention still outperforms treatment. Not to mention, the measles vaccine is safe and provides 97% protection from the disease after two doses.
🔢 Key Figure
75%
That’s how much the biotech-focused XBI index, a performance tracker for U.S. biotech companies, has rebounded since a 20% drop on April 4. It has now climbed back to levels not seen since late 2021. Analysts say momentum could carry into 2026 as long as strong data keeps winning and pricing headwinds stay manageable. 🙄
🌎 Community Vibes
What biotech Twitter, Reddit, and LinkedIn were really talking about this week:
“Unlimited PTO is a scam.” One redditor debated leaving big pharma for better pay at a smaller biotech, but was hesitant to give up their unlimited PTO for a mere 15 days off. Other redditors reminded them unlimited PTO usually just means unused vacation never gets paid out. A win for the company, not you. Try taking 30 days and see how “unlimited” it feels. You might come back to the office only to find your badge no longer gets you in the front door.
“When do you kill a program?” Researchers discussed how ending a project means betting against your own work using imperfect data. Letting go of sunk cost may be the hardest skill in R&D leadership.
🧬 BioBits
FDA Clears a Prescription App — Doctors may soon tell ADHD patients to “download your prescription” after Lumosity won clearance as a digital therapeutic.
HeartBeam — Successfully appealed an FDA rejection and secured clearance for its cable-free ECG device, which is the size of a credit card. Persistence matters.
Cannabis Stocks Rally — Reports that marijuana could be reclassified to Schedule III sent Tilray shares up 33% in recent days.
Lumexa Imaging — Blew past expectations with a $462.5M IPO, more than doubling its original target.
EU Pharma Policy Overhaul — Europe agreed on sweeping pharma reforms aiming to boost their competitiveness, though industry confidence is still cautious.
💭 Words to Remember
“Innovation distinguishes between a leader and a follower.”
— Steve Jobs
🗓️ This Day in History
🌋 December 16, 1707 — Mount Fuji erupted in the powerful Hōei eruption, blanketing Edo (modern-day Tokyo) in ash and creating a new crater. It remains the mountain’s most recent confirmed eruption.
That’s all for today. See you Thursday 👋
May your trials hit significance and your budget approvals clear faster than an FDA priority voucher.
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