FDA Approves Guselkumab as First IL-23 Inhibitor with Both SC and IV Induction Options for UC and CD

The FDA has approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for adults with moderately to severely active ulcerative colitis (UC). This makes guselkumab the first and only IL-23 inhibitor to provide both SC and intravenous (IV) induction options for treating UC and Crohn’s disease, offering patients flexibility including self-administration from the start of treatment.

TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.

“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine and study investigator. “With today’s approval, UC patients and providers now have the choice of starting TREMFYA with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice.”

The UC SC induction approval is based on results from the Phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of TREMFYA® SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies. All multiplicity-controlled primary and secondary endpoints demonstrated statistically significant and clinically meaningful improvements with TREMFYA® compared to placebo across all clinical and endoscopic measures: 

• Early symptomatic response was observed, with TREMFYA® separating from placebo as early as two weeks and sustained through Week 24.

• Significantly greater proportions of patients treated with TREMFYA® 400 mg SC every four weeks (q4w) achieved clinical remission (26% vs. 7%; p<0.001) and endoscopic improvement (36% vs. 12%; p<0.001) at Week 12 vs. those treated with placebo.

• Results were consistent with the FDA-approved 200mg IV induction regimen, which previously achieved clinical remission (23% vs. 8%; p<0.001) and endoscopic improvement (27% vs. 11%; p<0.001) vs. those treated with placebo. The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy.

• Week 24 SC induction followed by SC maintenance data also demonstrated statistically significant and clinically meaningful improvements in clinical remission (100 mg: 34%, 200 mg: 34% vs. 10%; p<0.001) and endoscopic improvement (100 mg: 39%, 200 mg: 44% vs. 12%; p<0.001) vs. those treated with placebo.

“With today’s approval, TREMFYA is the first and only IL-23 inhibitor to offer inflammatory bowel disease patients robust clinical and endoscopic results with a fully subcutaneous regimen, now across both ulcerative colitis and Crohn’s disease,” said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “The initiation of a head-to-head study in Crohn’s disease is a further testament to our commitment to advancing the clinical evidence of TREMFYA in IBD.”

TREMFYA® dosing in the treatment of moderately to severely active UC:

• The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4 and 8. TREMFYA® is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at Weeks 0, 4 and 8.

• Recommended maintenance dosage is either 100 mg administered by SC injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at Week 12, and every 4 weeks thereafter. Healthcare providers are instructed to use the lowest effective recommended dosage to maintain therapeutic response.

Johnson & Johnson is committed to supporting access to all its treatments, including offering a patient support program called TREMFYA withMe. Commercially insured adult patients who are prescribed TREMFYA® for UC may be eligible to receive their first induction treatment in as little as 24 hours through TREMFYA withMe.

In September 2024, Johnson & Johnson received FDA approval of TREMFYA® (with IV induction) for the treatment of adults with moderately to severely active UC, based on the Phase 3 QUASAR study. In March 2025, TREMFYA® received FDA approval, including both SC and IV induction options, for the treatment of adults with moderately to severely active CD.4 Based on the positive outcomes of clinical programs, Johnson & Johnson is initiating the first IL-23 inhibitor head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab), representing an important next step in Crohn’s disease research.

This approval is another important milestone for patients and is emblematic of Johnson & Johnson’s continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases, including inflammatory bowel disease.

Powered by WPeMatico

DCI warns Dental Colleges- Upload BDS admission data by November 5 or face action

New Delhi: The Dental Council of India (DCI) has directed all dental colleges to upload details of BDS students admitted for the 2025-26 academic session on the DCI portal by November 5, 2025. Failure to comply will invoke Section 10B or 16A of the Dentists Act, implying that unreported admissions will be considered invalid.

MCC, Directorate General of Health Services, Government of India, uploaded the Revised NEET UG Schedule-2025 and Revised NEET-UG-2025 online Counseling (Allotment Process) for MBBS / BDS / B.Sc (Nursing) seats of All India Quota / Deemed/ Central University / State Quota. The MCC has declared the last date for joining the BDS Course for the academic session 2025-26 as 05.11.2025, and as per the  Revised Counselling Schedule issued by the MCC, the date of commencement of the academic session will be remain same as 22.09.2025, the DCI pointed out.

According to the DCI notice, only data uploaded on the DCI portal will be accepted; emails or hard copies will not be considered. No deadline extensions will be granted, and technical issues will not be entertained. 

Colleges must upload student details after each round of NEET UG counselling, not wait till the last day. Strict warning issued against uploading false admission data — action will be taken for incorrect entries. Only uploaded data will be sent to the State Dental Councils for BDS registration.

Colleges are urged to ensure timely and accurate data entry to avoid penalties and litigation.

” Accordingly, the college authorities of all dental colleges are hereby directed to upload the details of students, admitted in BDS Course at their dental institution for the academic session 2025-26, on DCI Website, using their already allotted login credentials for admissions portal of dci, on or before the last date of joining i.e. 5th November, 2025 (12:00 midnight), positively. If the college authorities claim any admission after 12:00 midnight of 5th November, 2025, then Section 10B of the Dentists (Amendment) Act, 1993 and/or Section 16A of the Dentists Act, 1948, as the case may be, shall be attracted and it shall be presumed that the college authorities have not admitted such student(s) in BDS Course at their college for the academic session 2025-26,” the DCI mentioned.

“In order to ensure smooth uploading the details of students and to avoid the unnecessary delay, undue pressure and technical fault on network, in uploading the details of the students at the last moment of cut-off date, each and every dental institutions shall make its efforts to upload the details of students gradually, immediately after the date of joining of student of each round of counseling, but not later than 12.00 Midnight of 5th November, 2025, in any circumstance. In other words, the college shall not wait for uploading the details of its students for last moment of cut-off date and the details would be uploaded by the college after each round of counseling,” the notice read.

“Moreover, it has come to notice that some dental colleges upload the details of students who are not admitted in their college, because of which the college where the student has actually taken admission is unable to upload the details. Colleges are hereby strictly warned to upload the details of only the genuine and bonafide admissions of their college. The onus of furnishing true, correct and authentic information is upon the college concerned and in case of furnishing any wrong / incorrect information, it shall be open to DCI to initiate action against / penalize the college. Only the uploaded details of students on DCI portal shall be forwarded to the State Dental Councils / Tribunals for registration of BDS degree,” the DCI said.

“It is also to inform you that only uploaded details of students on DCI Website shall be considered and any detail of students received in any other format viz. e-mail or hard copy shall not be considered at all, therefore, you are requested not to send the subject details through e-mail or post or any other mode. It is also stated that no request for extension of time to upload the above details of students or any other excuse or reason of technical fault, etc. shall be considered, therefore, you are again requested to ensure and make available all arrangements at your end to complete the above task, in time, so as to avoid any litigation and to enable this Council to take necessary action in a time bound manner,” the notice added.

To view the full official notice click here: https://medicaldialogues.in/pdf_upload/lno5624-301633.pdf

Powered by WPeMatico

Why mosquitos might be attracted to you

Researchers in the Netherlands turned a major music festival into an unexpected laboratory to investigate a question that has long puzzled scientists and bug-bitten individuals alike: What makes some people more irresistible to mosquitoes than others?

Powered by WPeMatico

Does ASMR really help with anxiety? A psychology expert explains the evidence

Most of us have experienced tingling or “goosebumps” at some point, especially when we feel a strong positive emotion such as awe or excitement.

Powered by WPeMatico

Is it OK to sit on public toilet seats?

If you’re a parent or have a chronic health condition that needs quick or frequent trips to the bathroom, you’ve probably mapped out the half-decent public toilets in your area.

Powered by WPeMatico

How much progress has been made against Alzheimer’s disease?

After decades of unsuccessful research, two new drugs and a pioneering blood test have recently given Alzheimer’s patients hope of fighting back against the debilitating disease—but questions remain about their effectiveness.

Powered by WPeMatico

Study reveals why some medical cannabis patients use illegal products

Use of medical cannabis has been on the rise since it first became available to Utah patients in 2020. A medical cannabis card, which can be prescribed for difficult-to-treat conditions including PTSD and chronic pain, allows a patient to access licensed cannabis products in designated pharmacies.

Powered by WPeMatico

Skill-based, virtual learning integration with traditional medical education- NMC, NBE introducing innovative reforms

New Delhi: The National Medical Commission (NMC) is introducing innovative reforms in medical education to strengthen competency-based learning.

Dr Abhijat Chandrakant Sheth, Chairman of National Medical Commission presided over the 11th Convocation Ceremony of the Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) and Dr Ram Manohar Lohia Hospital today.

Speaking on the occasion, Dr. Sheth highlighted innovative initiatives being introduced by the National Board of Examinations in Medical Sciences and the National Medical Commission (NMC), such as integrating skill-based and virtual learning alongside traditional physical education, to fulfill the requirements of competency-based medical education. He encouraged the students to prioritize their own health and well-being, to persevere through challenges, and to remain lifelong learners.

Dr. Sheth congratulated the graduating students as well as their parents and faculty members for their dedication in guiding and motivating the students towards a service in healthcare. He emphasized the government’s commitment to increasing the number of doctors in the country to meet the World Health Organization’s recommendation of maintaining a uniform doctor-patient ratio of 1:1000 nationwide.

Also Read:AIIMS Bhubaneswar 5th Convocation: 196 MBBS, 158 MS, 49 MD graduates conferred degrees

Dr Abhijat Chandrakant Sheth also shared ongoing efforts to achieve a balanced undergraduate (UG) to postgraduate (PG) ratio of 1:1, aiming to elevate the quality of India’s healthcare system to the standards of developed countries.

Dr Sunita Sharma, Director General of Health Services (DGHS) and Dr Vinod Kotwal, Additional Secretary, Ministry of Health and Family Welfare were also present.

Dr. Vinod Kotwal emphasized that today’s occasion represents the culmination of years of hard work by the students and remarked, “This marks the beginning of your lifelong commitment to the health and well-being of the nation.” She also congratulated ABVIMS for its recent NABH accreditation, which “stands as a recognition of the institution’s steadfast dedication to quality, safety, and patient-centered care”.

Dr. Kotwal urged the students to continue pursuing knowledge, discovery, and service with integrity, compassion, and respect as their guiding principles. “Medicine is not just about curing disease; it’s about caring for the patients who suffer,” she said.

Dr. Sunita Sharma, in her address to the graduating students, noted, “You are not merely receiving a degree today; you are shouldering a profound responsibility—to heal, to lead, and to serve the nation in whatever capacity you choose.” Whether pursuing clinical care, medical research, or education, she advised, “Let your work be driven by empathy, evidence, and excellence.”

Emphasizing the sanctity of the medical profession, Dr. Sharma declared, “This is a noble calling built on compassion and an unwavering commitment to human life.” She concluded by encouraging the graduates to remain humble and grounded, no matter how far they go or how much they achieve in life.

During the ceremony, degrees were presented to 250 Post-graduate and DM students and the first batch of 100 MBBS graduates. The annual report of ABVIMS (Samhita) was also released on the occasion.

Also Read:First Convocation Ceremony of AIIMS Gorakhpur held, 8 doctors conferred Gold medal by President Murmu

Powered by WPeMatico

Rajasthan Chemists Warn of Indefinite Strike Over Rs 880 Crore Unpaid Govt Dues

Jaipur: A major crisis is brewing in Rajasthan’s healthcare supply chain, with chemists and pharmacists across the state warning of an indefinite strike over unpaid government dues of nearly Rs 880 crore. The mounting backlog has left thousands of medical shops and suppliers struggling to stay afloat, sparking concerns of medicine shortages if the issue remains unresolved.

Chemists allege that payments for medicines supplied to government hospitals, primary health centres, and other facilities have been delayed for months. Many small-scale shop owners say they are under severe financial strain, with distributors unwilling to provide fresh stock while earlier bills remain pending. The situation, they warn, could soon bring routine supplies of essential drugs to a grinding halt.

Representatives of chemist associations have demanded immediate intervention from the state government and a fixed timeline for clearance of outstanding bills. They argue that while promises have been made on multiple occasions, concrete action is missing, leaving over 10,000 pharmacies affected. For many, cash flow has dried up to the extent that staff salaries and basic operations have become difficult to sustain.

Also Read: Chemist Body Seeks Transition Period, GST Input Adjustment After Tax Cut, Writes to CM

The associations are now preparing to escalate their agitation and have indicated that if dues are not cleared promptly, supply to government institutions will be stopped. This would directly hit patient care in public health facilities, especially those in rural areas heavily dependent on state-run medical services.

According to PTI, the chemists’ bodies have already sent repeated representations to the health department, but with no satisfactory response so far. The looming strike, if carried out, could have a ripple effect on healthcare delivery across Rajasthan.

Also Read: Puducherry launches raids against private chemists flouting norms on anti-TB drugs sale

Powered by WPeMatico

CCMP row: Maha doctors to intensify protest if Govt fails to act

Mumbai: After holding a state-wide strike on September 18 against the registration of homoeopathic practitioners with a Certificate Course in Modern Pharmacology (CCMP) under the Maharashtra Medical Council (MMC), doctors under the banner of the Indian Medical Association (IMA) have now announced their next course of action.

The IMA has decided to wait for seven days for a positive response from the state government. If the controversial notification allowing CCMP-certified homoeopaths to register with MMC is not withdrawn, the doctors have warned of intensifying their agitation.

In a statement, the association stated that the next phase of the protest will include a long march, agitation at Azad Maidan, hunger strike, and complete withdrawal of health services across the state. The association said that this movement will involve nearly two lakh allopathic doctors and their associations.

Also read- Around 1.8 lakh doctors strike in Maharashtra against Homeopath-CCMP registration

At the same time, the IMA has stated that it will also approach the Supreme Court over the issue. The body has appealed to its members to contribute generously to the legal fund to strengthen their case.

This comes after the association, on September 18, met with the Chief Minister at Chhatrapati Sambhajinagar and handed over their memorandum. After this, the government took cognisance of their strike and requested the doctors to call off their strike.

Observing that their protest had reached higher levels, the association decided to wait for seven days for the government’s response to the matter. 

Medical Dialogues recently reported that nearly 1.8 lakh doctors across Maharashtra staged a strike opposing the state government’s move to allow homeopathic practitioners with CCMP to register with the Maharashtra Medical Council.

While emergency and critical services were unaffected, doctors from government, BMC, and private hospitals participated. The protest followed the government’s fresh circular on September 5, reviving CCMP registration despite earlier withdrawal.

Earlier this year, the state government directed the Maharashtra Medical Council (MMC) to register homoeopaths who had completed the one-year Certificate Course in Modern Pharmacology (CCMP), to allow them to prescribe allopathic medicines to patients in select cases.

However, the notification was withdrawn after the IMA Maharashtra members, who planned a strike on July 11 but deferred it until further notice, met with Chief Minister Devendra Fadnavis and explained about the confusion among patients.

The government issued a fresh circular on September 5, reviving the registration process. A fresh government resolution (GR) was issued in this regard on September 5, upsetting allopathic practitioners, who decided to go ahead with the 24-hour strike.

“All 231 branches of IMA Maharashtra observed the strike seriously on 18th September 2025. It was one of the biggest strikes in recent times,” said the association in a recent statement after the strike. 

Expressing gratitude to resident doctors and other medical associations for joining the strike in solidarity, IMA said, “We deeply appreciate the joining of MARD in Strike & Our Strength doubled. We thank each and every allopathic practitioner who kept OPDs and hospitals closed and participated in the protest. We also thank MAGMO and MSMTA, who supported the protest by wearing black ribbons. Special thanks to AMC, MSRDA, ASMI, AFPI FAIMA FORDA and all associations of allopathic doctors who shut down their clinics and hospitals. We also appreciate the participation of corporate hospitals.”

What is the issue?

The CCMP course was started based on the Government Resolution dated 13.03.2014. The course was conducted under the Maharashtra University of Health Sciences (MUHS), Nashik. After successful completion, eligible homeopathic practitioners received training in allopathic (modern) medicine to serve in public healthcare services. In 2014, the Maharashtra Medical Council issued a notice in which the council was given the authority to ask all doctors who have completed the CCMP course to register with the council.

Back in 2017, the State Medical Education and Drugs Department passed a notification and allowed Homeopaths to practice modern medicine and register with MMC. However, allopathic doctors strongly opposed this move and the matter ultimately resulted in IMA challenging the amendments in the Bombay High Court in 2014. Consequently, the HC bench stayed the notification.

While the matter was awaiting a court judgment, the Maharashtra Medical Council (MMC) had, on June 30, officially decided to allow homeopathic practitioners who completed the CCMP course to register with the council and prescribe allopathic medicines. MMC was directed to register CCM-qualified around 10,000 to 90,000 homeopathic doctors in Maharashtra, in a separate register starting July 15. However, the decision was put on hold and the Government suspended the registration process after IMA warned to initiate a statewide strike.

Following this, the Maharashtra Medical Education and Drugs Department formed a seven-member special committee to decide whether homoeopathic doctors who have completed the Certificate Course in Modern Pharmacology (CCMP) should be allowed to register with the Maharashtra Medical Council and practice modern (allopathic) medicine.

Registration of CCMP-qualified Homeopaths with MMC:

The Maharashtra Medical Education and Drugs Department directed the Maharashtra Medical Council (MMC) to start the registration of homoeopathy practitioners who have completed a one-year Certificate Course in Modern Pharmacology (CCMP).

This resulted in a strong protest among the medical practitioners across the State. Medical Dialogues had earlier reported that IMA had termed the Government’s decision as “dangerous” and “a threat to public health”, and it had also highlighted that the government’s order was in contempt of court as the matter was already pending before the High Court.

Again, on 12th September 2025, the association wrote to the Chief Minister and expressed its deep concern and strong objection to the recent circular issued by the Medical Education and Drugs Department, Government of Maharashtra. IMA mentioned in the letter that the direction to the Maharashtra Medical Council to give registration to CCMP (Certificate Course in Modern Medicine and Surgery for Practitioners of Indian Systems of Medicine), passed homeopathic medical practitioners, “poses a serious threat to the safety and quality of healthcare services.”

The association demanded an immediate stay on the decision to register CCMP doctors in the Maharashtra Medical Council and urged the Government not to implement any decisions until the pending High Court case is resolved. As per the association, only fully trained and qualified MBBS doctors should be granted licenses for modern medicine.

Powered by WPeMatico