INDIAN COUNCIL OF MEDICAL RESEARCH
🇮🇳India
- Country
- 🇮🇳India
- Ownership
- Private
- Established
- 1911-01-01
- Employees
- 1K
- Market Cap
- -
- Website
- http://www.icmr.nic.in
India Launches First Indigenous HPV Test Kits for Cervical Cancer Screening
• Indigenously developed HPV test kits for cervical cancer screening were launched in Delhi, targeting the seven to eight most common cancer-causing HPV types specific to India's population.
• The RTPCR-based diagnostic kits, validated through collaborative research led by AIIMS Delhi, offer a cost-effective alternative to traditional Pap smears and HPV DNA tests for national cancer screening programs.
• With cervical cancer being the second most common cancer among Indian women and accounting for 25% of global mortality, these kits align with WHO's recommendation for HPV testing as the preferred screening method.
Ozempic Significantly Improves Walking Distance in Patients with Type 2 Diabetes and Peripheral Artery Disease
• Phase 3 STRIDE trial results show Ozempic (semaglutide) 1 mg increased maximum walking distance by 13% compared to placebo in patients with type 2 diabetes and peripheral artery disease.
• Patients treated with semaglutide experienced a clinically meaningful median improvement of 26.4 meters in walking distance on a 12% incline, along with better pain-free walking and quality of life measures.
• Based on these positive findings, Novo Nordisk has submitted a label extension application to the FDA, potentially making Ozempic the first new medication in over two decades to improve functional outcomes in PAD patients.
Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors
• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes.
• As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage.
• Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.
Immuneel Launches Qartemi, a CAR T-cell Therapy for Non-Hodgkin's Lymphoma in India
• Immuneel Therapeutics has launched Qartemi, India's first CAR T-cell therapy for treating adult B-cell Non-Hodgkin Lymphoma (B-NHL).
• Qartemi is a personalized therapy that modifies a patient’s T-cells to target and eliminate cancer cells, offering hope for lasting remission.
• Clinical trials in India and Spain demonstrated that Qartemi's safety and efficacy are similar to US FDA-approved CAR T-cell therapies.
• Priced at approximately ₹35 to ₹50 lakh, Qartemi is significantly more affordable than similar treatments in the US.
Dengue Vaccine Landscape Evolves: New Candidates Show Promise in Clinical Trials
• Several dengue vaccine candidates are progressing through clinical trials, offering potential solutions for this widespread disease.
• Butantan-DV showed 67-79% efficacy in preventing dengue in a Phase 3 trial in Brazil and is awaiting regulatory approval.
• Panacea Biotech, in collaboration with ICMR, initiated a Phase 3 trial for their DengiAll vaccine in India after promising early-stage results.
• Codagenix Inc. received $5.88 million from the U.S. Department of Defense to advance its CodaVax-DENV tetravalent vaccine candidate.
India Launches First Indigenous Antibiotic Nafithromycin to Combat Drug-Resistant Pneumonia
• India has launched Nafithromycin, its first indigenously developed macrolide antibiotic, to combat antimicrobial resistance (AMR).
• Developed by Wockhardt with BIRAC support, Nafithromycin (Miqnaf) targets Community-Acquired Bacterial Pneumonia (CABP), offering a three-day treatment regimen.
• Clinical trials showed Nafithromycin to be ten times more effective than current treatments, with superior safety and minimal side effects.
• The Indian government has also initiated multiple strategies, including surveillance, awareness programs, and international collaborations, to tackle AMR comprehensively.
Zydus and ICMR Partner to Initiate Phase 2 Trial of Desidustat for Sickle Cell Disease
• Zydus Lifesciences and the Indian Council of Medical Research (ICMR) have partnered to begin Phase 2 clinical trials of Desidustat for sickle cell disease.
• The Phase IIa trial is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of oral Desidustat.
• The primary endpoint is the proportion of patients with a hemoglobin response (≥1 g/dL increase) compared to placebo at weeks 4 and 8.
• Desidustat, a HIF-prolyl hydroxylase inhibitor, aims to address the unmet need for effective sickle cell disease treatments beyond hydroxyurea.
India Updates Drug and Healthcare Regulations, August 2024
• The Drugs Controller General of India (DCGI) has waived clinical trial requirements for specific drug categories approved in certain countries.
• The CDSCO has mandated manufacturers to comply with revised Schedule M and WHO Technical Report Series guidelines for pharmaceutical products.
• The Ministry of Health and Family Welfare banned 156 fixed-dose combination drugs due to potential risks to human health.
India's First COVID-19 Vaccine, COVAXIN, Enters Clinical Trials with Accelerated Timeline
• Bharat BioTech's COVAXIN, developed with the National Institute of Virology, initiates Phase 1 clinical trials involving 375 participants to assess safety and efficacy.
• The accelerated timeline for COVAXIN's clinical trials, aiming for completion by August 15, has faced criticism from experts citing potential health risks.
• Zydus Pharma and BioNTech have also announced their own vaccine candidates, increasing the number of companies developing potential coronavirus vaccines in India.
• India now ranks third globally in COVID-19 cases, surpassing Russia, with over 11.6 million infections and 537,000 deaths reported.
India ICMR Partners with Industry to Advance Phase I Clinical Trials
• The Indian Council of Medical Research (ICMR) has formalized partnerships with industry and academic institutions to facilitate first-in-human phase one clinical trials for four novel pharmaceutical agents.
• The collaborations will support diverse research projects, including a CAR-T cell therapy study for chronic lymphocytic leukemia and trials for a small molecule targeting multiple myeloma.
• Four institutions across India will form a network to conduct these early-phase clinical trials, supported by infrastructure and manpower to ensure efficient trial execution.
• According to Dr. Rajiv Bahl, establishing a phase one clinical trial infrastructure is crucial for fostering the development of indigenous molecules and innovative treatments.
ICMR Partners with Industry for First-in-Human Trials of Novel Therapies
• ICMR has formalized agreements with multiple sponsors to advance four promising molecules into first-in-human clinical trials, marking a significant step for pharmaceutical innovation in India.
• The collaborations include research into a small molecule for multiple myeloma, a Zika vaccine, a seasonal influenza vaccine, and CAR-T cell therapy for chronic lymphocytic leukemia.
• This initiative aims to establish India as a leader in the clinical development of pharmaceutical agents through strategic public-private partnerships, enhancing the nation's capacity for early-phase clinical trials.
• The ICMR Network for phase 1 clinical trials includes four institutions across India, supported by a central coordinating unit, to ensure smooth and effective trial operations.
ICMR Partners with Industry to Advance First-in-Human Phase 1 Clinical Trials in India
• The Indian Council of Medical Research (ICMR) has signed agreements to advance first-in-human Phase 1 clinical trials for four molecules.
• Collaborations include research for multiple myeloma, Zika vaccine development, influenza vaccine trials, and CAR-T cell therapy advancements.
• This initiative aims to establish India as a leader in pharmaceutical clinical development and affordable healthcare solutions.
• The ICMR network includes four institutions across India, enhancing the capacity for early-phase clinical trials with robust infrastructure.
Phase 3 Trial of India's First Indigenous Dengue Vaccine, 'DengiAll,' Commences
• The Phase 3 clinical trial for 'DengiAll,' India's first indigenous tetravalent dengue vaccine developed by Panacea Biotec and ICMR, has begun at KIMS, Bhubaneswar.
• The trial will assess the vaccine's efficacy against all four serotypes of the dengue virus, addressing a critical need in a country where dengue is prevalent.
• KIMS is the only site in Odisha and one of 18 sites across India participating in the Phase 3 trial, aiming to recruit over 500 participants in Bhubaneswar.
• Previous Phase 1 and 2 trials of DengiAll have shown promising results, paving the way for this late-stage trial to potentially license the vaccine.
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