Some details on J&J's restructuring plans

Johnson & Johnson is bracing for a major overhaul that will invariably involve sweeping layoffs around the globe. FiercePharma reports that J&J held a town hall meeting this past week that included discussion of a "comprehensive review" of its portfolio. The company plans on merging its vaccines and infectious diseases unit as part of the revamp; it also will be "deprioritizing some programs" in its pipeline.

Notably, J&J will be ending work on all of its antibacterial therapeutic efforts, Fierce writes, and will end work on its hepatitis B and D programs. It's also scaling back on its work on Covid-19 vaccines. It's also winding down work on HIV vaccines, after seeing an experimental candidate fail in phase 3. The company will double down on work in the pre-exposure prophylaxis space, however, in flu, RSV, and the common cold, among other areas.

covid-19

Clinical outcomes for vaccine-linked myocarditis

Covid vaccine-linked myocarditis has been a pressing concern for quite some time now, but the prognosis of this rare heart inflammation hasn't been clear. A study in BMJ Medicine tracks the clinical outcomes of myocarditis that followed mRNA vaccinations in four Nordic countries. It found that the myocarditis that resulted from vaccinations was actually much more treatable than conventional myocarditis and more treatable than the myocarditis stemming from a Covid-19 infection.

The paper followed 7,292 people who were admitted to the hospital with new-onset myocarditis between 2018 and 2022, and then tracked them for 90 days, looking for heart failure, death, or readmission to the hospital. A handy Twitter thread outlines the results here.

wall street

Another pharma earnings week

In advance of this week's installment of quarterly biopharma earnings, Jefferies is calling Vertex Pharmaceuticals "the cleanest large-cap biotech growth story." The company has plenty of cash and a balanced pipeline, with numerous programs entering phase 3 or nearing the filing stage with regulators.

Other companies reporting this week include Alnylam, Illumina, AstraZeneca, and 23andMe. Illumina, of course, has stumbled lately thanks to its travails with the Grail resorption. Analysts generally are expecting lower revenues for the genomics giant.

prophylaxis

The case for Covid convalescent plasma

All approvals for monoclonal antibodies that help prevent or treat Covid-19 have been rescinded because they've been rendered ineffective by newer variants of the virus. But there's still one overlooked antibody option: Covid convalescent plasma. Although it lost favor earlier in the pandemic thanks to an influx of engineered antibody infusions, convalescent plasma "remains highly effective at reducing hospitalizations and death in people with Covid-19," a trio of physicians who research the stuff write.

The plasma from people vaccinated against Covid-19 is particularly potent, they say — since it evolves with the variants and retains an ability to neutralize them. And plasma is inexpensive compared to other treatment options — hundreds of dollars per unit compared to thousands per dose for monoclonal antibodies — meaning that it wouldn't be prohibitively expensive to use at scale, they say.

breast cancer

Gilead's Trodelvy gets another approval

Gilead's breast cancer drug, Trodelvy, was approved Friday for the most common form of the disease — a week ahead of its scheduled PDUFA date. The antibody-drug conjugate is now sanctioned to treat HR-positive, HER2-negative breast cancer, which accounts for about 70% of new breast cancer diagnoses around the world. Specifically, Trodelvy can now be used in patients with this form of the disease who have already received endocrine-based therapy and at least two other systemic treatments for metastasis.

Trodelvy was first FDA approved in 2020 for metastatic triple-negative breast cancer, and in 2021 was green-lighted for urothelial cancer.

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