Issue #17·

Novo Nordisk hid patient deaths from the FDA for over 800 days

The biggest name in weight-loss drugs just got caught sitting on serious safety reports, including two deaths and a completed suicide, some filed more than two years late. Meanwhile, bacteria that eat tumors are headed to Wall Street, a new gene editing approach thinks bigger than CRISPR, and Iran just hacked a major medical device company.

Top Story Today

Novo Nordisk's Safety Reporting Just Got a Very Public Failing Grade

Two patient deaths. A completed suicide. At least ten serious adverse events. All tied to Ozempic, Wegovy, or Saxenda, and none properly reported to the FDA. Some filings were over 800 days late (long enough for a baby to be born and start walking). The FDA's March 5 warning letter didn't question the drugs' safety; it torched Novo Nordisk's entire reporting system, citing structural flaws like requiring consent from reporters before investigating deaths. The agency said it has "serious concerns" about the company's full product portfolio, not just GLP-1s.

Why it matters: When the company dominating pharma's most commercially important drug class can't reliably report side effects, it undermines the post-marketing surveillance system that protects millions of patients taking these medications every day.

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Science and Discovery

A New Gene Editing Tool Thinks CRISPR Is Thinking Too Small

CRISPR can fix a DNA typo; a new gene editing approach wants to replace entire missing genes. The trick: circular single-stranded DNA that sneaks past your cells' immune defenses like a delivery driver in an unmarked van. The technology could unlock treatments for thousands of rare diseases where current editors simply can't handle the payload size. It's only been tested in cells and mice so far, but the gene editing community is calling it "beautiful work."

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Cybersecurity and Industry

Iran-Linked Hackers Just Wiped 200,000 Systems at Stryker

An Iran-linked group called Handala hit the medical device giant on March 11, wiping systems remotely and claiming to steal 50 terabytes of data. No surgical robots or defibrillators were compromised, but global HQ closed and new orders are under review. It's a significant escalation in state-backed threats to healthcare infrastructure.

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Deals, IPOs, and Layoffs

A Biotech Wants $91M to Send Tumor-Eating Bacteria After Pancreatic Cancer

Salspera just set IPO terms for up to $91 million to fund a Phase 3 trial of saltikva, a genetically engineered Salmonella you swallow as a pill. The bacteria colonize tumors and produce immune-activating proteins from the inside. Phase 2 data showed median overall survival of 20 to 24 months, nearly double the standard of care, with zero serious side effects attributed to the drug itself.

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839 Institutions Fought Over Every Share of This Korean Biotech's IPO

IM Biologics, a preclinical-stage South Korean biotech, drew 839-to-1 institutional demand for its KOSDAQ listing, pricing at the top of its range. The catalyst: a near-billion-dollar licensing deal with US startup Navigator Medicines, backed by RA Capital. The company raised roughly $37 million and debuts March 20 with a 76% institutional lock-up rate, signaling genuine long-term conviction.

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Amgen Subleases Its $27.8B Acquisition's R&D Hub While Evotec Axes 800 Jobs

Two years after buying Horizon Therapeutics for $27.8 billion, Amgen is subleasing the 192,000-square-foot Rockville R&D facility and cutting 22 staff. Separately, Evotec announced 800 layoffs and four site closures by 2027, about a sixth of its workforce. Both moves reflect biotech's ongoing post-COVID reckoning, where the $500 million in promised cost savings increasingly comes at the expense of the science those acquisitions were supposed to fuel.

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