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The sBLA is supported by data from the Phase 3 UNITI-Jr clinical study, a multicenter, open-label study to evaluate the efficacy, safety, and pharmacokinetics of STELARA for the treatment of pediatric CD through 52 weeks.

“Living with a lifelong condition like Crohn’s disease can be incredibly challenging, especially for children and adolescents who may experience more severe symptoms and faster disease progression than adults. With limited approved treatment options to support the specific needs of this patient population, many children with a Crohn’s disease diagnosis continue to struggle,” said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “With the well-established efficacy and safety profile of STELARA in existing indications, this submission aims to better support these patients, their families, and providers with a new treatment option.”

Of the nearly one million people in the U.S. living with CD, approximately up to 25 percent are children and the rate of CD in this younger population continues to rise. Crohn’s disease can be more severe for the pediatric population compared to adults, further highlighting the need for additional treatment options^.

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease. Nearly one million people in the U.S. are living with CD, approximately up to 25 percent of those individuals are pediatric.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.

New Delhi: The Delhi High Court has granted bail to an AIIMS doctor, who was accused of raping a woman under the pretext of marriage. The court noted that two were, prima facie, involved in ”an active and consensual live-in relationship”. 

Justice Shalinder Kaur, who was hearing the bail plea of the junior resident doctor, said the woman got more FIRs registered for similar offences against others and some cases, including that of extortion, were also filed against her.

“Significantly, this court has also been informed by the counsel for the petitioner that the prosecutrix has lodged other FIRs of offences similar to the one in the present case, against other persons and also that some FIRs have been lodged against her,” the court said, news agency PTI reported.

Also Read:RML Hospital Staff granted bail in alleged bribery case

The extortion case was registered against the woman, in which she was accused of extorting money from a man and his family, threatening them with criminal implications.

In its order dated May 30, the court said, “What emerges from the material placed before this court is a complex factual matrix wherein contradictory versions regarding the nature of the relationship between the petitioner (doctor) and the prosecutrix must be carefully weighed.” The 39-year-old woman was stated to be an educated adult, previously married with a child with special needs. She was found to have resided with the doctor and his family for 15 days.

“It is evident from the record that despite alleging that the petitioner had sexually assaulted her in early December 2024, the prosecutrix had failed to report any incident to the police, and no explanation for the same has been put forth, and in fact, the prosecutrix continued to stay with him,” the court said.

It also came on record that the woman did not inform the doctor’s family about the alleged forcible sexual assaults.

The prosecution alleged that the doctor gave false assurances of marriage but his counsel called it a consensual live-in relationship and said no promise of marriage was ever made.

“Suffice to say, the prosecutrix, being a mature, educated and married woman, must be deemed to understand how marriage rituals work. Nonetheless, the said allegations would be a matter for the trial,” the court said, reports PTI.

The material on record “prima facie” indicated to the court that the doctor and the complainant were “in an active and consensual live-in relationship”.

“Screenshots of WhatsApp chats, travel plans, shared photographs, and other materials prima facie suggest mutual affection and cohabitation. In the medico-legal case (MLC), certain contradictions are appearing as well,” the order read.

The court said Delhi Police had filed a chargesheet in the present case and the trial would take considerable time.

“The petitioner, a 28-year-old doctor serving in AIIMS, holds a permanent job and has no criminal antecedents. This court also notes that he has cooperated with the investigation, and there is no material to show that he has attempted to abscond or tamper with evidence,” the court said.

The man was ordered to furnish a personal bond of Rs 50,000 and two sureties of the like amount.

The doctor was booked for rape, voluntarily causing hurt and voluntarily causing hurt or grievous hurt by dangerous weapon or means.

Also Read:Orthopaedic Surgeon arrested in fake degree case Granted Bail