Daily briefings
Editor’s Briefing: October 9, 2026
In Short. Viatris agreed to buy Pacira BioSciences, which makes two non-opioid pain drugs, for about $1.65 billion. Newron disclosed four deaths among patients taking its schizophrenia drug, and the FDA said its abortion pill review will run into 2027.
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Viatris agrees to buy Pacira for $1.65 billion
DOCTORS try to limit opioids after surgery because of the risk of addiction, and Pacira BioSciences sells two non-opioid pain drugs. Exparel is bupivacaine, an old local anesthetic, packed into liposomes, tiny fat bubbles that release it slowly at the surgical site. Zilretta is triamcinolone, a steroid, in an extended-release form injected into knees with osteoarthritis. On Thursday Viatris, a large maker of generic and branded medicines, agreed to buy Pacira for $36.50 a share in cash, about $1.65 billion. Pacira had about $746 million in revenue in the 12 months to June. The deal is expected to close by the end of 2026. Under patent settlements, generic copies of Exparel can begin to enter in early 2030, and Zilretta’s patents expire in 2031. (Viatris and BioPharma Dive)
Newron reports four deaths on its schizophrenia drug
Schizophrenia that does not improve on standard antipsychotics is called treatment-resistant. Newron Pharmaceuticals, an Italian company, is testing evenamide as an add-on pill for these patients. It adjusts glutamate, a chemical nerve cells use to signal, by blocking certain sodium channels in those cells. Some sodium-channel blockers can disturb heart rhythm, and in April the FDA halted U.S. enrollment in the phase 3 ENIGMA-TRS 2 trial while it examined a patient death at a site abroad. On Thursday Newron said four patients given evenamide have died across its studies, 0.56% of those treated, against one death on placebo, or 0.27%. Investigators judged three unrelated to the drug and one possibly related, because two autopsies found no definite cause. Newron says it has seen no pattern of heart rhythm problems in its safety data so far, and the FDA hold placed in April remains in force. (BioSpace)
FDA says its abortion pill review will run into 2027
Mifepristone, taken with a second drug called misoprostol, is the most common method of abortion in the U.S. The FDA approved it in 2000 and has since eased its rules, including a 2021 decision that lets doctors prescribe it online and send it by mail. Health Secretary Robert F. Kennedy Jr. ordered a new safety review. In a filing late Wednesday in Louisiana’s lawsuit against mail delivery, the FDA said it expects to finish a safety study by mid-December. A report will follow no later than March 2027, after which the agency will decide whether to change how the drug is prescribed or dispensed. The Supreme Court has blocked changes to the drug’s rules until the case returns to it. (STAT/AP)
TRex Bio raises $117 million in its stock market debut
Regulatory T cells, or Tregs, are immune cells that stop the immune system from attacking the body’s own tissue. TRex Bio makes drugs meant to activate them and so calm inflammation. The company sold 8,333,334 shares at $14 each, raising about $117 million, and begins trading on Nasdaq on Friday. Its lead drug, TRB-061, is a fusion protein that binds TNFR2, a receptor on Tregs, and is designed to make them multiply and reduce inflammation in the skin and gut without broadly weakening immunity. A phase 1 study is under way, with first results expected in 2027. Eli Lilly owned about 24% of TRex before the offering. TRex is one of 23 drug developers to list in the U.S. this year, six of them working on immune diseases. (BioPharma Dive)
What to watch
pdufa.bio lists an FDA decision on Roche’s Enspryng in thyroid eye disease on October 15 and on GSK’s hepatitis B drug bepirovirsen on October 26. Kyverna will present one-year results for its cell therapy in stiff person syndrome at a meeting in Toronto on October 21.