This website uses cookies

Read our Privacy policy and Terms of use for more information.

πŸ‘‹ Hey, let’s get into it. The GLP-1 rivalry has officially progressed from clinical trials and television commercials to the pharmaceutical industry’s preferred combat arena: a New Jersey courtroom.

Novo Nordisk is suing Eli Lilly over ads claiming Zepbound delivered 50 pounds of average weight loss compared with 33 pounds for Wegovy. Novo argues Lilly highlighted data from Wegovy’s older 2.4-mg dose while burying the newly approved 7.2-mg version in a barely readable disclaimer.

Lilly says the comparison comes from the only randomized head-to-head trial available. Novo says consumers were misled. Our condolences to the judge, who now has to binge-watch pharmaceutical commercials for work.

πŸ“° Headliners

πŸ’Έ Trump Plans 100% Tariff on Generic Drugs Beginning in 2028
President Donald Trump announced plans to impose a 100% tariff on imported generic drugs beginning in August 2028, followed by a 200% rate one year later. The two-year reprieve is intended to give manufacturers time to build U.S. facilities, though no formal order has been released. The policy would heavily affect India, which supplies nearly half of America’s generic medicines, while exposing a difficult reality: low-margin drugs, overseas ingredients, and expensive domestic factories do not magically become compatible because someone typed β€œRESHORE” in capital letters.

🧊 Repligen Buys BioLife Solutions for $1.5B in Cell Therapy Expansion
Repligen is acquiring BioLife Solutions for $1.5 billion, gaining cryopreservation products used to store and transport major cell therapies including Carvykti, Yescarta, and Breyanzi. BioLife’s CryoStor media is also embedded across much of the late-stage cell therapy pipeline, where switching products can be costly and operationally painful. Repligen expects commercial cell therapy programs to grow more than 20% over the next five years and sees opportunities to cut costs, cross-sell products, and expand BioLife internationally. Sometimes the best biotech investment is the cooler everyone already uses.

πŸ’° Royalty Pharma Pays Up to $425M for AstraZeneca’s ATTR Drug Royalties
Royalty Pharma is paying Neurimmune $125 million upfront and another $125 million next year for a 3% to 4% royalty on worldwide sales of AstraZeneca’s experimental ATTR drug cliramitug. Clinical and regulatory milestones could lift the total deal value to $425 million. The antibody targets misfolded transthyretin deposits and has shown reductions in cardiac amyloid at higher doses in early testing. AstraZeneca’s Alexion unit is running a Phase 3 trial expected to read out in 2028. Royalty Pharma is once again buying the future cash register before the store officially opens.

πŸ’Š Gilead and Merck’s HIV Pill Could Be the First Once-Weekly Oral Treatment
Gilead and Merck moved closer to delivering the first complete once-weekly oral HIV treatment after their islatravir-lenacapavir combination matched daily regimens at maintaining viral suppression through 48 weeks. The two Phase 3 ISLEND trials found the single tablet was effective and had a safety profile comparable to daily oral therapies such as Biktarvy. For patients managing lifelong treatment, reducing medication from seven days a week to one could ease both adherence and the constant psychological reminder of living with HIV.

🫁 Summit & Akeso’s Ivonescimab Cuts Death Risk 24% in Western Lung Cancer Patients
Summit Therapeutics and Akeso reported that Western patients receiving ivonescimab plus chemotherapy had a 24% lower risk of death than those receiving standard care after 23.2 months of follow-up. The result closely tracked data from China, where the reduction reached 26%, helping counter concerns that the PD-1/VEGF bispecific’s earlier success might not translate across populations. Summit did not disclose whether the Western subgroup result was statistically significant, but investors welcomed the consistency. The China-to-Western-data discount is not gone, but ivonescimab just gave it a meaningful haircut.

😊 Start therapy today, feel better tomorrow
Get matched with a licensed therapist and get flexible support by chat, phone, or video. Take control of your mental health today and save 20% on your first month.
*Offer valid for new users only, cannot be combined with insurance

⚑️ Quick Hits

πŸ‡ΊπŸ‡Έ Rare Disease Leadership Becomes a National Security Issue
A congressional panel warned China could overtake U.S. rare disease development without faster FDA pathways, flexible trials, and stronger domestic policy support.

πŸ€– FDA Authorizes J&J’s OTTAVA Surgical Robot
J&J won De Novo authorization for its table-integrated OTTAVA system, officially entering a surgical robotics market still dominated by Intuitive.

🧬 Genetic Medicine Veterans Launch Personalized Therapy Center
The new Center for Therapeutic Genetics will unite Broad, Boston Children’s, and Jackson Laboratory scientists to develop individualized genetic medicines.

πŸ‡­πŸ‡° Axiom Plans First Hong Kong-First Listing by a U.S. Biotech
Axiom Biosciences plans a 2027 Hong Kong IPO before pursuing Nasdaq, following encouraging early data for two fatal newborn neurological diseases.

πŸ’° Crystalys Raises $130M for Phase 3 Gout Drug
Crystalys’ Series B will advance dotinurad through registration studies and launch preparations, following its unusually large $205 million Series A.

πŸ™Œ Arrowhead’s Redemplo Cuts Pancreatitis Risk 78%
Two Phase 3 trials showed triglyceride reductions near 80% and a 78% drop in pancreatitis, setting up an FDA filing this year.

πŸ‘Š Sanofi Reprimanded Over Pfizer RSV Vaccine Claims
A U.K. watchdog found Sanofi used misleading data interpretations to disparage Pfizer’s RSV vaccine and undermine confidence in the pharmaceutical industry.

🧐 Deep Dive

πŸ„ Psychedelics Finally Get a Seat at the Big Pharma Table

Ever wonder about the first person who ate a wild mushroom and suddenly watched the forest breathe? They were probably relieved not to die…and then extremely interested in doing it again.

Humans have used mind-altering plants and fungi for millennia, but Western psychedelic research largely disappeared after the drugs became synonymous with the 1960s counterculture and were classified as Schedule I substances. Decades later, the comeback is no longer confined to wellness retreats and Silicon Valley dinner parties.

Eli Lilly’s $2.8 billion upfront acquisition of AtaiBeckley may be the clearest validation yet. The deal gives Lilly BPL-003, a fast-acting intranasal form of 5-MeO-DMT that has produced encouraging results in treatment-resistant depression. It follows AbbVie’s $1.2 billion Gilgamesh partnership and Otsuka’s $700 million acquisition of Transcend Therapeutics.

The science is becoming harder to dismiss. Psychedelics may temporarily loosen rigid communication patterns in the brain, creating a window in which therapy can help patients process depression, trauma, or addiction differently. Companies are now engineering shorter trips, milder experiences, safer compounds, and delivery methods that fit existing clinics.

Commercial proof already exists. J&J’s ketamine-derived Spravato generated $584 million last quarter and could exceed $2 billion this year. Meanwhile, positive clinical data, FDA guidance, and political support have reduced some of the regulatory uncertainty that scared investors away after Lykos’ 2024 setback.

The remaining challenge is logistics. A two-hour nasal treatment fits healthcare infrastructure better than an eight-hour supervised LSD session. The winners may not produce the wildest trip. They may produce the one insurers, clinics, and patients can actually schedule.

πŸ”’ Key Figure

20%

This is the portion of Americans using GLP-1s for weight loss that still relies on non-FDA-approved versions: nearly one in five, despite regulatory crackdowns, lawsuits, and safety concerns. Another 12% are unsure what they use. The compounded market may be shrinking, but affordability continues beating brand recognition at the pharmacy counter.

🌎 Community Vibes

Here’s what biotech Redditors are talking about:

πŸ’Š Will Oral GLP-1s Replace the Needle?
Reddit could not agree whether obesity pills will disrupt injectable GLP-1s. Pill supporters pointed to easier manufacturing, shipping, storage, and a much larger pool of needle-averse patients. Injection defenders argued weekly shots are simple, effective, and quickly become routine. The one point nearly everyone agreed on: insurance coverage will probably matter more than dosage form. Patients may prefer swallowing a pill, but they prefer not swallowing the entire monthly cost even more.

πŸ’Έ A Postdoc Discovers Industry Salaries and Questions Everything
After five years earning $63,000 as a postdoc, one immunologist learned a former classmate now makes $138,000 in pharma and immediately updated their rΓ©sumΓ©. Reddit’s reaction ranged from sympathetic career advice to genuine confusion that the salary gap came as a surprise. Commenters stressed that academia, industry research, and drug development offer very different careers. Not just different paychecks. The discussion eventually devolved into industry scientists joking about yacht maintenance, as all thoughtful compensation discussions eventually do.

🧬 BioBits

🧠 Jupiter Pays Up to $100M for PharmAla’s MDMA Drug
Jupiter secured U.S. rights to ALA-002, a specialized MDMA formulation already supplying government-backed trials in PTSD and other neuropsychiatric disorders.

πŸ† J&J and Time Launch Healthcare Champion Award
The new annual honor will recognize a healthcare professional demonstrating grit, innovation, and care, with nominations remaining open through August 28.

🧾 Amgen Agrees to $74M Investor Settlement
Amgen will settle allegations that it concealed a potential $10.7 billion IRS dispute tied largely to profits shifted through Puerto Rico.

🐭 House Passes Animal Testing Reform in FDA Modernization Act 3.0
The legislation would require FDA regulations to reflect federal permission for non-animal testing methods in preclinical drug development.

πŸš€ Startup Spotlight

♻️ Ashlins Pharma Builds a Business From Medicines Left Behind
Ashlins Pharmaceuticals is betting rare disease innovation does not always require discovering something new. The startup licensed ex-China rights to an interferon alpha-2b formulation in a deal worth up to $31 million, aiming to restore access for patients who lost treatment options when older products were discontinued. Founder Jennifer Lin, a Thiel Fellow, has raised $1.7 million and plans to seek another $50 million. Ashlins’ model is simple: find clinically validated medicines stranded by commercial decisions, then finish the job.

πŸ—“οΈ This Day in History

πŸ’‰ July 23, 1986: The First Genetically Engineered Vaccine Arrives
On this day in 1986, the FDA licensed Merck’s Recombivax HB, the first vaccine created using recombinant DNA technology. Instead of extracting hepatitis B antigens from human plasma, scientists inserted the gene for a viral surface protein into yeast, transforming the cells into microscopic vaccine factories. The approval moved genetic engineering from an exciting laboratory concept into everyday medicine. Today, recombinant vaccines feel routine. Back then, asking yeast to manufacture part of a virus sounded like science fiction with regulatory paperwork.

πŸ€” Final Thoughts

Thinking back to psychedelics, scientists spent decades trying to convince everyone these compounds might have legitimate medical value. Now Eli Lilly is spending $2.8 billion to join the trip.

Somewhere, the surviving members of The Beatles are probably nodding politely while β€œTomorrow Never Knows” plays in the background…Turns out they may have been conducting early market research.

That’s all for today. See you Tuesday for the next issue. πŸ‘‹

✍️ Today’s email was brought to you by Josh Martin.

πŸ“¬ Share This Newsletter

If you’re enjoying BioNucleus, share it with a friend or coworker who’d get value from it. We’re a small operation, and every share makes a bigger difference than you think.

Was this email forwarded to you? Sign up here πŸ‘‡

Follow us on social and stay one step ahead

πŸ“£ Want to Reach the People Building Biotech?

BioNucleus Briefing lands in the inboxes of 1,300+ scientists, founders, investors, operators, and industry decision-makers twice a week.

If you'd like to sponsor a future issue, just hit reply and let's talk.

Keep Reading