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Johnson & Johnson

Johnson & Johnson failed to inform FDA over faulty blood testing device in Phase III trial

The British Medical Journal, after its own investigation, found that Janssen knew early into the Phase III trial, known as the ROCKET AF trial, that the blood testing device used to test an anti-clotting drug was not working correctly. The trial was for the blockbuster drug Xarelto (rivaroxaban), which was pitted in the trial against warfarin.

Johnson & Johnson’s Stelara receives FDA approval

The drug is approved for use to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. Crohn's disease is a chronic inflammatory condition in the gastrointestinal tract, causing abdominal pain, diarrhoea, rectal bleeding, weight loss and fever. It affects about 700,000 Americans and nearly 250,000 Europeans, according to Johnson & Johnson.

J&J in $4.33bn eye surgery unit acquisition

Johnson & Johnson has agreed to buy Abbott Laboratories’ eye surgery equipment unit in an all-cash deal for £4.33 billion as part of its strategy to boost its three core businesses.

GSK and J&J file rheumatoid arthritis treatment sirukumab in EU

GlaxoSmithKline and partner Johnson & Johnson’s Janssen Biologics unit have filed for approval of rheumatoid arthritis (RA) treatment sirukumab in Europe in an attempt to compete with Roche’s $1.5 billion Actemra.

Sirukumab is an anti-interleukin (IL)-6 monoclonal antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that plays a role in autoimmune conditions, and is designed to interrupt the autoimmune process in RA.

Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for its drug to treat intestinal worm infestations. 

The company said the 500mg chewable mebendazole tablet will provide a treatment and prevention alternative for soil-transmitted helminthiasis (STH). 

J&J raises FY outlook, Q1 beats estimates

Healthcare giant Johnson & Johnson (NYSE: JNJ) raised its full-year outlook and posted first-quarter earnings ahead of estimates despite currency headwinds.

The company now sees full year earnings of $6.53 to $6.68 a share, up from $6.43 to $6.58 a share forecast earlier. J&J also raised its full year revenue estimates to $71.2 billion to $71.9 billion, from the previously estimated $70.8 billion to $71.5 billion

Janssen slams NICE decision on Imbruvica

Janssen, the R&D arm of pharma major Johnson & Johnson, says it is extremely disappointed following regulator NICE’s announcement that it does not intend to recommend its Imbruvica (ibrutinib) to treat chronic lymphocytic leukaemia (CLL).

J&J fined $72 million in talc cancer case

A Missouri jury has ruled that Johnson & Johnson must pay $72 million to the family of an Alabama woman, who claim that her death was caused by use of the company’s baby powder, and other talcum products.

Jacqueline Fox died of ovarian cancer last year, aged 62, having used the baby powder, as well as the company’s Shower to Shower product, for some 35 years as part of her daily routine, and believing that it contributed to her cancer. Upon her death, the case was taken up by her son.

Investigation questions Xarelto trial data accuracy

Xarelto
Bayer submitted the ROCKET-AF trial for regulatory approval with the FDA and the EMA

The ROCKET-AF trial, the pivotal trial of the top-selling anti-clotting drug Xarelto, could have been undermined by unreliable results from a blood testing device, it has been claimed.

An investigation in the BMJ alleges that the results, drawn from analysis of data from blood testing devices that measured the effectiveness of Xarelto (rivaroxaban), could be invalid. The testing device that was used during the trial was recalled in December 2014, after being found to give falsely low test results.

Johnson & Johnson begins Ebola vaccine trial in Sierra Leone

Ebola virus

Johnson & Johnson has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies, in the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.

Trial recruitment for the EBOVAC-Salone study is underway, with the first volunteers having received their initial vaccine dose; the study will take place in Sierra Leone’s Kambia district, where some of the country’s most recent Ebola cases have been reported.<

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