Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more research-oriented pharmaceuticals and medical devices business segments. The announcement follows similar moves made by other large pharmaceutical and medical device companies.
The placebo-controlled trial, ENSEMBLE, will enroll up to 60,000 healthy volunteers on three continents. The trial will test the vaccine JNJ-78436735, also known as Ad26.COV2.S.
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The drugmaker emphasized the full global rights it would acquire to Momenta's lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.
The company said Friday that it had received FDA approval for Darzalex Faspro, a version of the intravenous Darzalex designed for faster administration and that carries a better toxicity profile.
According to a preprint paper posted Tuesday, scientists at the company tested the drug, Prezista, against the virus in a cell culture, but found it had no activity. A combo therapy that includes Prezista's active ingredient is in clinical trials in China.
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J&J will work under an existing partnership with the department to develop a vaccine against COVID-19, while Moderna said it had produced the first batch of its own vaccine. Attendees at a recent biotech conference expressed concerns about the outbreak's impact on drug manufacturing.
In an interview on CNBC's "Squawk Box," Paul Stoffels, the drugmaker's chief scientific officer, said the company had started working on a vaccine two weeks ago, but it could take a year to reach the market.
The FDA approved Spravato in March, but a new paper in JAMA examines some of the barriers inherent in the practice and reimbursement of psychiatry that could get in the way of widespread use of the drug.
The drug was approved along with a companion diagnostic to detect alterations in FGFR2 and FGFR3. The drug is approved for patients with locally advanced or metastatic UC who carry those mutations.
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The drug, a reformulation of ketamine, was approved for patients who have failed on other antidepressants. The original form of ketamine, approved as an anesthetic, has long been explored as a treatment for depression.
In a post on its website by an executive, the company said it would begin including list price and out-of-pocket cost information for an anticoagulant later this quarter.
Mr. Alex Gorsky needs to provide a more reasoned explanation for his decision to remain on President Trump's American Manufacturing Council and what he can achieve even as five CEOs have departed following Mr. Trump's response to Charlottesville.
Gary Pruden, worldwide chairman of medical devices at Johnson & Johnson steps down after 32 years at the company but his departure announcement comes sans the usual pat-on-back recognizing long service.
Chairman and CEO Alex Gorsky describes J&J's portfolio "little bit like your children, you love all of them" but one is getting the stepchild treatment.