Topic
Drug & device safety: latest medical news
Safety communications, recalls, trial deaths, adverse events and pharmacovigilance.
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
Source: FDA
FDA approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus infection in certain adults without cirrhosis. BioPharma Dive reports the GSK/Ionis drug is viewed as a potential 'functional cure' for chronic infection.
Why it mattersA new mechanism added on top of standard antivirals changes the HBV treatment conversation for hepatologists, and a new product means a new label, risk-management plan and post-marketing safety surveillance to watch.
Patient dies in Bristol Myers Squibb autoimmune CAR-T trial
Source: STAT
STAT reports a patient death in a Bristol Myers Squibb trial of CAR-T therapy for an autoimmune condition, and asks where the safety bar should sit for these studies (full story is STAT+).
Why it mattersAutoimmune patients are not facing the same risk-benefit trade-off as patients with refractory cancer, so serious events in this setting will shape regulator, IRB and sponsor tolerance for the whole CAR-T-in-autoimmunity field.
Moderna, Merck shares fall on eagerly anticipated cancer vaccine results
Source: BioPharma Dive
In a landmark melanoma study, the Moderna/Merck personalized cancer vaccine (intismeran) plus Keytruda cut the risk of relapse or death by 42%, a result that met Wall Street expectations but triggered a 'sell-the-news' share drop.
Why it mattersThis is a key test of individualized mRNA cancer vaccines in the adjuvant setting; oncologists will want the full ESMO data, and regulators a first look at a new class with its own manufacturing and safety questions.
Remibrutinib versus teriflunomide in relapsing multiple sclerosis (REMODEL-1 and REMODEL-2)
Source: The Lancet
In two randomised trials, Novartis's oral BTK inhibitor remibrutinib was superior to teriflunomide in relapsing MS while maintaining a favourable safety profile, per the authors. STAT reports it cut relapse rates by a third versus the standard treatment.
Why it mattersBTK inhibitors have faced liver-safety scrutiny as a class, so the hepatic safety detail in the full paper matters as much as efficacy for neurologists and drug-safety teams.
GLP-1 compounder issues recall for copycat Zepbound
Source: BioPharma Dive
A compounding pharmacy has recalled a compounded tirzepatide product that copies Zepbound, adding to concerns about knockoff weight-loss drugs that stay popular despite FDA warnings and legal pressure from Lilly and Novo.
Why it mattersPatients on compounded GLP-1s may not be visible in brand pharmacovigilance data, so clinicians should ask what product patients are actually injecting when assessing adverse events.
Hospital Glucose Meter Removal: Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems
Source: FDA MedWatch
FDA posted a removal notice for StatStrip Glucose Hospital Meter Systems, which need a software update because glucose results could be assigned to the wrong patient.
Why it mattersA point-of-care result filed under the wrong patient can drive wrong insulin dosing; hospitals using StatStrip should confirm the software update and their barcode-scanning workflow.
Genmab shares rise after Rina-S hits PFS and OS in phase 3 ovarian cancer trial
Source: RTTNews
Genmab shares gained about 10% on Friday after the phase 3 RAINFOL-02 trial of rinatabart sesutecan (Rina-S) in platinum-resistant ovarian cancer met its primary progression-free survival endpoint and key secondary overall survival endpoint, per RTTNews; Genmab reported a 71% reduction in risk of progression or death and 57% reduction in risk of death versus investigator's-choice chemotherapy.
Why it mattersPlatinum-resistant ovarian cancer has few effective options, and an OS benefit for an FRα-targeted ADC is a strong regulatory and commercial signal; Genmab plans to discuss the data with regulators. Not investment advice.
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