The U.S. Food and Drug Administration authorized the use of an additional batch of Johnson & Johnson’s one-dose Covid-19 vaccine manufactured at the problem-plagued Baltimore factory of Emergent BioSolutions Inc.

Infectious disease experts are weighing the need for booster shots of the Pfizer/BioNTech or Moderna mRNA-based vaccines for Americans who received Johnson & Johnson’s one-dose vaccine due to the increasing prevalence of the more contagious Delta coronavirus variant.

Johnson & Johnson decided to terminate a $1.6 billion partnership with Argenx to develop the anti-CD70 antibody cusatuzumab to treat amyotrophic lateral sclerosis (AML) and myelodysplastic syndromes (MDS).

Now, a few years down the road,

Safety concerns about Johnson & Johnson’s Covid-19 vaccine along with overall flagging demand for vaccinations have slowed its U.S. rollout to a crawl, leaving close to half of the 21 million doses produced for the United States sitting unused.

The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).

During the Digestive Disease Week meeting, AbbVie presented late-breaking data analyses that showed both doses of Skyrizi met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo in two Phase III studies. The Lancet published results from pivotal global Phase III clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating Rinvoq (upadacitinib) in adults and adolescents with mild to severe atopic dermatitis who were candidates for systemic treatment.

The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The Janssen Pharmaceutical Companies of Johnson & Johnson presented data from the Phase 3 VOYAGER PAD study which showed Xarelto (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization compared to aspirin alone regardless of whether it was the first, second, third or subsequent event.

The U.S. Centers for Disease Control and Prevention (CDC) is investigating the death of an Oregon woman and the hospitalization of another in Texas after receiving Johnson & Johnson’s Covid-19 vaccine, state health officials said.

A U.S. health advisory panel on April 14 is set to review six reported cases of rare blood clots in women who received Johnson & Johnson’s Covid-19 vaccine one day after federal regulators paused the use of the shot to assess the issue.