| | | |   | Hey there, it’s Meghana. Today we have more details on the patient who died while taking lecanemab, a STAT special report on the tenuous future of voluntary licensing deals, and more. | | | Details about lecanemab patient death in NEJM The first detailed case report of a patient who died from “extensive” brain bleeds after receiving the closely watched experimental Alzheimer’s drug lecanemab has been published in the New England Journal of Medicine. Although Science wrote about an unpublished version of the report back in November, this “will have greater impact on clinicians because it is peer-reviewed and published in the New England Journal,” one Alzheimer’s expert told STAT. The FDA will pass judgment on lecanemab, made by Eisai, as soon as this week. The report will likely fuel debate among clinicians on whether or not to prescribe the amyloid-clearing biologic. That’s because the case is complex: The 65-year-old woman who died had two copies for APOE4 gene, which heightens a person’s risk for developing Alzheimer’s. That genetic makeup also increases a person’s likelihood of developing swelling or bleeding when they receive any antibody drug that attempts to remove amyloid. Notably, Eisai’s U.S. chief Ivan Cheung has previously warned doctors against using lecanemab in patients with two copies of the gene unless they’re rigorously monitored for brain bleeds and swelling. Read more. | How impactful are these voluntary licensing deals? Novartis was roundly applauded this past fall for agreeing to license Tasigna, its best-selling leukemia drug, so that generic companies could distribute it to 44 low- and middle-income countries. But some say this Medicines Patent Pool deal is a bit hollow: Tasigna’s key patent expires in 2023. That means generic versions would likely become available regardless of the vaunted deal. “It’s just very limited,” according to the WHO’s head of intellectual property for medicine access. “This makes it different from previous licenses. So it’s problematic, because even if it’s good to have a first license for a cancer drug, it’s not really the standard we want. I don’t think we’ll see any real progress in terms of impact.” The agreement has raised questions about whether or not voluntary licensing deals can realistically improve access to medicine around the globe. Read more. | Why scientists are sprinting toward new treatments for blood disorders Millions of people around the world suffer from blood disorders today, while scientists race to find new treatments and potential cures. In December, blood disorder specialists from around the globe will convene in New Orleans to share research and medical advances at the 64th annual meeting of the American Society of Hematology. Among them will be Pfizer scientists, who will be sharing more than 30 abstracts across Pfizer’s hematology portfolio. Learn more about what they have to say. | Roivant-Pfizer inflammatory bowel drug outperforms expectations An experimental drug for inflammatory bowel disease from Roivant Sciences and Pfizer really did rather well: The drug, RVT-3101, prompted 32% of the trial participants with ulcerative colitis to go into remission, compared to 12% in the placebo group. It targets a protein called TL1A that’s linked to inflammation and tissue scarring — the same approach as competitor Prometheus Biosciences. Analysts had been wowed by results last month from Prometheus, which helped 27% of participants to enter remission. They said Roivant and Pfizer’s trial would have “to be stellar to be in the same ballpark." Clearly, RVT-3101 got the job done. Roivant stock was up 7% in premarket trading on the news. Read more. | After long last, a modest success for Geron Corp. Geron Corporation made a name for itself in the nineties and aughts for hinting at the potential for immortality. In the years since, it’s been under the radar. But its experimental drug has now proved effective in a late-stage trial for a group of chronic blood disorders.
The disease, called myelodysplastic syndromes, typically requires routine blood transfusions and can progress to leukemia. Geron's drug allowed patients to go for longer periods of time — even over a year — without these transfusions.
But there were significant side effects, which could limit uptake of the drug. For instance, it led to very low platelet counts and dramatically reduced the number of infection-fighting neutrophils in over 60% of patients. But despite concerns over the drug's safety, “clearly there seems to be clinical efficacy,” one hematologist said. These results could prove to be a lifeline for Geron, which had been running low on cash. Read more. | More reads - 3 drug pricing issues to watch in 2023, STAT
- Moderna CEO says mpox vaccine is 'fantastic.' It may never see the market, FierceBiotech
- Biotech investor Brad Loncar shares 10 predictions for 2023, Business Insider
| Thanks for reading! Until tomorrow,  | | | |
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