Medical Dialogues

CDSCO Waives Local Clinical Trials for Drugs Approved in Select Countries: Health Minister All new drugs are approved by the Central Drugs Standard Control Organization (CDSCO) without local clinical trials on case to case basis in consultation with Subject Expert Committee, the Lok Sabha was recently informed. The revelation came from Union Health Minister Anupriya Patel in response to a query raised by Tirupati MP Maddila Gurumoorthy on Friday. Additionally, the MP questioned the present status and the impact on drug availability and affordability in the country. The MP asked whether the Union Health Ministry has decided to waive the requirement of clinical trials for drugs approved in countries like the US, UK, Japan, Australia, Canada, or the European Union (EU). #newdrugs #cdsco #clinicaltrials #localtrialswaiver #subjectexpertcommittee #newdrugsandclinicaltrialsrules #healthministeranupriyapatel #parliamentquestion #maddilagurumoorthy #loksabha

Suven Pharma to acquire controlling stake in NJ Bio with investment of USD 64.4 million  Suven Pharmaceuticals Limited has announced the acquisition of a controlling stake in NJ Bio, Inc. with an investment of $64.4 million. Suven will acquire 56% stake in NJ Bio (pre-money valuation of US$100mn) through a combination of primary and secondary: - US$49.4mn for buying out the existing minority shareholders - US$15mn as primary equity infusion; will be mainly used for capex (GMP expansion at the existing Princeton facility) - Deal is valued at a low-to-mid teens multiple of CY25 projected EBITDA, based on growth outlook - Call/Put Option arrangement to acquire balance stake after 5 years Based in Princeton, NJ Bio is a ADC/XDC-focused CRDMO offering cutting-edge solutions across the ADC value chain. It was founded by Dr Naresh Jain, a well renowned scientist in the ADC space, holding PhD from Boston University & Post Doctoral Research Fellow at The Scripps Research Institute, California. He had previously founded The Chemical Research Solution LLC (an ADC CRO) and served in senior R&D roles at J&J for 8+ years. NJ Bio has served 150+ customers, delivered over 500 projects in 5 years, and won the prestigious World ADC Awards for four consecutive years (2021- 24). Dr. Jain will continue to lead NJ Bio in the next phase of its growth, along with the senior leadership group and a skilled scientific workforce that he has brought together over the years. NJ Bio is expected to record revenues of ~US$32 million in CY24, reflecting a 70%+ CAGR since CY2021. The Company has consistently invested in R&D to develop novel technology platforms related to ADC drug development as well as a more recently set up a cGMP compliant manufacturing facility. The transaction is expected to close before the end of December 2024. #suvenpharma #suvenpharmanews #investment #NJBio

AstraZeneca Imfinzi granted priority review by USFDA for muscle-invasive bladder cancer AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025. Approximately one in four patients with bladder cancer has evidence of the tumour invading the muscle wall of the bladder (without distant metastases), known as MIBC. In MIBC, a curative-intent setting, approximately 117,000 patients are treated with current standard of care. Standard treatment includes neoadjuvant chemotherapy and radical cystectomy. However, even after cystectomy, patients experience high rates of disease recurrence and a poor prognosis. The sBLA is based on data from the NIAGARA Phase III trial which was presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine. In the trial, patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy followed by Imfinzi as adjuvant monotherapy, or neoadjuvant chemotherapy before radical cystectomy. In a planned interim analysis, perioperative Imfinzi demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the Imfinzi regimen were event free at two years compared to 59.8% in the comparator arm. Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the Imfinzi regimen were alive at two years compared to 75.2% in the comparator arm. Susan Galbraith #astrazeneca #astrazenecanews #imfinzi #durvalumab #bladdercancer

Health Ministry Reconstitutes Expert Panel for J&J ASR Hip Implant Compensation The Ministry of Health and Family Welfare has reconstituted its Central Expert Committee to address compensation issues concerning faulty ASR hip implants manufactured by DePuy International Ltd., now a part of Johnson & Johnson Pvt. Ltd. The newly constituted committee will be led by Dr. Ajay Kumar Shukla, , Professor of Orthopaedics, RML Hospital (New Delhi) to determine the quantum of compensation as admissible and medical management for the affected patients who were implanted with faulty ASR Hip implant. In 2005, Johnson & Johnson received FDA approval for its metal-on-metal Articular Surface Replacement (ASR) hip implant devices, namely the XL Acetabular Hip System and Hip Resurfacing System. However, in 2010, the company issued a global recall of these devices due to widespread patient complaints of post-surgery pain, metal ion leaching, and infections. Recognizing the potential impact on Indian patients, the Indian Health Ministry formed an 11-member expert committee in 2017 to investigate the matter. Nearly 4,700 patients in India had received these implants. In February 2018, the committee concluded that J&J was responsible for the defects in the implants. Subsequently, on November 29, 2018, a central expert committee under the health ministry approved a compensation scheme. The compensation amount, ranging from Rs 30 lakh to Rs 1.23 crore, was determined based on factors such as age and disability level. All states were directed to establish state-level committees to identify eligible patients, verify their claims, and determine the appropriate compensation based on the approved formula. Recently, the drugs regulator in its latest notification has asked the patients who were implanted faulty ASR and have suffered disability and other losses to approach either the central expert committee or state level expert committees. #healthministry #centralexpertcommittee #asrhipimplants #johnson&johnson #depuyinternational #faultyimplants #compensationscheme #articularsurfacereplacement #statelevelcommittees #compensation #jnj #johnsonandjohnson #JnJnews

Lupin bags tentative USFDA okay for Abacavir, Dolutegravir, Lamivudine Tablets for Oral Suspension for HIV treatment  Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to market a generic equivalent of Triumeq PD Tablets for Oral Suspension, of ViiV Healthcare Company. This product would be manufactured at Lupin’s Nagpur facility in India. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. HIV-1 (Human Immunodeficiency Virus Type 1) is a virus that attacks the immune system, specifically targeting CD4+ T cells, which are crucial in defending the body against infections. HIV-1 is the most common and widespread strain of the virus that causes HIV infection and, if untreated, can progress to AIDS (Acquired Immunodeficiency Syndrome). Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, (RLD Triumeq PD) had an estimated annual sale of USD 1.3 million in the U.S. (IQVIA MAT September 2024). Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its ANDA for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC. #lupin #lupinnews #USFDA #abacavir #dolutegravir #lamivudine #triumeqPDTablets #ViiVHealthcare #HIV

AstraZeneca Imfinzi gets USFDA nod for limited-stage small cell lung cancer AstraZeneca's Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine. SCLC is a highly aggressive form of lung cancer. LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy. The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis. In the trial, Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo. Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo. The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed. Imfinzi is also approved in Switzerland in this setting based on the ADRIATIC results. Regulatory applications are currently under review in the EU, Japan and several other countries in this indication. #astrazeneca #astrazenecanews #Imfinzi #durvalumab #lungcancer

Remembering India's First Female Doctor: Dr Anandibai Joshi Dr. Anandibai Joshi's story is a beacon of hope for women pursuing education and careers in medicine. Her spirit lives on through the Anandibai Joshi Award for Medicine and various fellowships in her honor, inspiring women to break societal barriers. To watch the full story click on the link below: https://lnkd.in/gvFwNqWG #dranandibaijoshi #firstfemaledoctor #medicine

https://lnkd.in/gKcsW3EG  AUROBINDO PHARMA LTD has announced that its wholly owned subsidiary company, EugiaPharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Pazopanib Tablets, 200 mg is indicated for the treatment of adults with Advanced Renal Cell Carcinoma(RCC), and Advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy. The product is expected to be launched in Q4FY25. The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA. This is the 179 th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products. Medical Dialogues team had earlier reported that Aurobindo Pharma, Dr Reddy's Laboratories, and Hetero Labs and 3 other pharmaceutical companies had signed memorandums of understanding (MoUs) with the Telangana government for setting up facilities in the Pharma City with an investment of over Rs 5,260 crore.

Cipla appoints Girish Verulkar as Director - Human Resources Pharma giant, Cipla, has appointed Girish Verulkar as Director - Human Resources. In a LinkedIn post, Girish shared, "I’m happy to share that I’m starting a new position as Director - Human Resources at Cipla!" Before joining Cipla, Girish served as General Manager and Head of HR & Admin at Sun Pharma. His previous experience includes working as Head & DGM- Plant Human Resources atLupin, along with roles at Andritz Hydro, Crompton Greaves, and Ashoka Buildcon. Verulkar holds a Master’s in Personnel Management from the Institute of Management & Research in Jalgaon. #cipla #ciplanews #sunpharma #lupin #appointment

Alembic Pharma bags USFDA tentative approval for Olopatadine Hydrochloride Ophthalmic Solution to treat itchy eyes  Alembic Pharmaceuticals Limited has announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories, Inc. NDA - 206276. #alembicpharma #alembicpharmanews #USFDA #olopatadinehydrochlorideophthalmicsolution #pataday #alconlabs