In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of June 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
• DCGI responds on clarifications sought by Pharmexcil on export NOC guidance document-
The Drugs Controller General of India (DCGI) has issued clarifications to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) regarding the recently released Guidance Document on Export No Objection Certificates (NOCs). Key clarifications include: (1) alternative documentation such as COPP/FSC or pharmacopoeial status for R&D exports, (2) acceptance of Registration Certificates (RCs) from the final destination country, even if goods transit through another country, (3) use of SRA approvals when Indian or importing country approvals are absent, and (4) recognition of product-specific approvals regardless of the applicant company. These clarifications aim to streamline and support pharmaceutical exports, especially in cases involving unapproved formulations, third-party exporters, and transitions through other countries.
• DCC agrees with DTAB proposal to fix QR codes on vaccines, antimicrobials, anticancer & NDPS drugs-
The Drugs Consultative Committee (DCC) has approved a proposal by the Drugs Technical Advisory Board (DTAB) to amend the Drugs Rules, 1945 for mandatory affixing of barcodes or Quick Response (QR) codes on the labels of all vaccines, antimicrobials, anticancer drugs, and narcotic and psychotropic substances. This initiative aligns with World Health Organization (WHO) Global Benchmarking requirements.
• DCC agrees with proposal to include Good Distribution Practices as part of Drugs Rules-
The Drugs Consultative Committee (DCC) has agreed to a proposal to amend the Drugs Rules, 1945, by including Good Distribution Practices (GDP) as a schedule after stakeholder consultation. The GDP guidelines, based on revised WHO TRS standards, aim to ensure proper storage and transportation conditions throughout the pharmaceutical supply chain. This move follows recommendations from the Parliamentary Panel on Chemicals and Fertilizers to make GDP legally enforceable to combat the issue of spurious and substandard drugs. This will hold manufacturers accountable for drug quality during distribution, addressing long-standing industry concerns.
• Ministry of Ayush launches portal to address issues of misleading advertisements and ADR-
The Ministry of Ayush has launched the Ayush Suraksha Portal to address issues of misleading advertisements and adverse drug reactions (ADRs) in accordance with the Supreme Court’s order on July 30, 2024. With this, the Ministry of Ayush now has a centralized and accessible dashboard of reported cases, enabling real-time tracking, swift regulatory action, and detailed data analysis and it also ensures that citizens have a direct channel to voice their concerns, with transparent visibility into the action taken on their reports and The Apex Court emphasized the need for a centralized dashboard for monitoring and publishing data related to misleading advertisements and adverse drug reactions. The Court directed the Union of India to ensure that such a system is established to allow State Licensing Authorities to report complaints, share inter-state referrals, and update the status of actions taken.
• Grant of WHO-GMP COPP through One Nation One Drug Licensing (ONDLS) portal-
The Central Drugs Standard Control Organization (CDSCO) has mandated that all applications for WHO-Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (COPP) must be submitted exclusively through the One Nation One Drug Licensing System (ONDLS) portal starting June 15, 2025. Physical submissions will no longer be accepted for manufacturing licenses and WHO-GMP (COPP) approvals. The ONDLS portal, developed by the Centre for Development of Advanced Computing (CDAC) in collaboration with state authorities, facilitates online licensing for sales, manufacturing, blood centers, and large volume parenterals.
Approvals
• Lupin introduces prucalopride tablets in United States-
Lupin has launched prucalopride tablets (1 mg and 2 mg) in the United States following approval from the United States Food and Drug Administration (US FDA). The drug is a generic equivalent of Takeda’s Motegrity and is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. The product recorded annual US sales of approximately USD 184 million as of April 2025.
• US FDA approves expanded label for GE HealthCare’s Vizamyl PET imaging agent for beta amyloid detection-
GE HealthCare has received approval from the United States Food and Drug Administration for an expanded label for its PET imaging agent Vizamyl (flutemetamol F 18 injection), enhancing its use in beta-amyloid detection. The updated label permits quantitative analysis of scans and removes prior restrictions, including limitations on using Vizamyl to monitor patient response to anti-amyloid therapy. This advancement allows clinicians to make more objective assessments of amyloid plaque buildup, aiding in better diagnosis and personalized treatment strategies for Alzheimer’s disease.
• Glenmark Pharma launches Tevimbra in India to treat lung and esophageal cancer
Glenmark Pharmaceuticals Ltd. has launched Tevimbra (tislelizumab), a programmed cell death protein 1 (PD-1) targeting monoclonal antibody, in India for treating lung and esophageal cancers. Approved by the Central Drugs Standard Control Organization (CDSCO), Tevimbra is used as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with chemotherapy, and as a second-line monotherapy for both NSCLC and esophageal squamous cell carcinoma (ESCC). Developed by BeiGene (now BeOne Medicines), Tevimbra is already approved in 46 countries and has been used to treat over 1.5 million patients.
• DeepEcho receives US FDA 510(k) clearance for its AI-powered prenatal imaging-
DeepEcho, an AI first healthtech company revolutionizing maternal and fetal health, has received clearance from the US Food and Drug Administration (FDA) for its fetal ultrasound analysis platform. This US FDA clearance marks a major milestone in DeepEcho’s mission to transform prenatal care and democratize access to quality fetal ultrasound.DeepEcho’s AI solution leverages advanced deep learning. Preventive health management in the country. With the launch of its new CGM, Tracky aims to help individuals manage diabetes through real-time insights and precision monitoring. The state-of-the-art device integrates modern sensor technology with a Bluetooth-enabled transmitter and a mobile app, offering a future-ready solution focused on innovation, affordability, and accessibility for the Indian population.
• CHMP recommends approval of Novo Nordisk’s Ozempic for peripheral arterial disease-
Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for updating the Ozempic (semaglutide) label to include results from the STRIDE trial in patients with peripheral arterial disease (PAD). Pending approval from the European Commission, Ozempic will be the only GLP-1 RA with demonstrated benefits in cardiovascular, kidney, and functional walking outcomes. Novo Nordisk has also submitted applications for Rybelsus label expansion in both the European Union and the United States.
• Celltrion receives United States Food and Drug Administration approval for new pediatric dose of Steqeyma
Celltrion has received approval from the United States Food and Drug Administration for a new 45 mg/0.5 mL single-dose vial of Steqeyma (ustekinumab-stba), a biosimilar to Stelara. This subcutaneous formulation is intended for pediatric patients aged 6 to 17 years and weighing under 60 kilograms, who are being treated for plaque psoriasis or psoriatic arthritis. With this approval, Steqeyma now offers all dosage forms of its reference product, supporting greater treatment flexibility and continuity.
• AstraZeneca & Daiichi Sankyo’s Datroway gets US approval for EGFR-mutated NSCLC.
The US FDA has granted accelerated approval to Datroway (datopotamab deruxtecan or Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for adult patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). Datroway is the first TROP2-directed therapy approved for lung cancer in the US. The treatment showed a 45%response rate and 6.5-month median duration of response in previously treated patients. The drug is part of an extensive global clinical programme and is being explored in variouscancers.
• Lupin Gets US FDA Tentative Approval for Oxcarbazepine ER Tablets
Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for oxcarbazepine extended-release tablets (150 mg, 300 mg, and 600 mg), which are bioequivalent to Supernus Pharmaceuticals’ Oxtellar XR. Indicated for the treatment of partial-onset seizures in patients aged six years and older, the drug will be manufactured at Lupin’s Nagpur facility.
- US FDA grants orphan drug designation to Sanofi’s riliprubart for antibody-mediated rejection in solid organ transplantation.
The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US.
• Alembic Pharmaceuticals gets USFDA nod for generic cancer treatment injection
Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its generic Doxorubicin Hydrochloride Liposome Injection, available in 20 mg/10 mL and 50 mg/25 mL strengths. This injectable drug is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
• EMA committee recommends marketing approval of AVT06, Alvotech’s proposed biosimilar to Eylea-
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing approval for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept 2 mg). Intended for treating eye conditions such as neovascular age-related macular degeneration and diabetic macular oedema, AVT06 demonstrated therapeutic equivalence in clinical trials. Alvotech will handle development and supply, while Advanz Pharma manages commercialization in Europe. If approved, AVT06 will expand patient access to biologic eye therapies across the European Economic Area.
• EMA accepts GSK’s MAA for linerixibat for cholestatic pruritus in patients with primary biliary cholangitis-
The European Medicines Agency has accepted GSK’s marketing authorization application for linerixibat, an investigational ileal bile acid transporter (IBAT) inhibitor, for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC). This follows earlier acceptance by the United States Food and Drug Administration. Currently unapproved globally, it could address a major unmet need in managing the debilitating itch experienced by up to 90% of PBC patients.
International Pharma News
• Biocon Biologics expands insulin access in Malaysia over 100 mn cartridges of rh-insulin supplied to Health Ministry; 345,000+ patients served-
Biocon Biologics’ Malaysian subsidiary, Biocon Sdn. Bhd., has surpassed the milestone of supplying over 100 million cartridges of recombinant human insulin (rh-insulin) to Malaysia’s Ministry of Health, benefiting 345,000+ diabetes patients since 2016. This achievement underscores the success of a public-private partnership between Biocon Biologics and Duopharma Biotech to enhance diabetes care, local manufacturing, and healthcare resilience. With a $600 million investment, Biocon has developed a state-of-the-art insulin manufacturing facility in Johor, recognized as Malaysia’s largest integrated insulin plant. The company aims to serve 1 in 5 insulin-dependent people globally, with 9.2 billion doses delivered worldwide to date.
• Aldeyra Therapeutics gets US FDA’s special protocol assessment agreement letter for its drug candidate, ADX-2191 to treat primary vitreoretinal lymphoma
Aldeyra Therapeutics has received a Special Protocol Assessment (SPA) agreement letter from the US FDA for its drug candidate ADX-2191 (methotrexate injection) aimed at treating Primary Vitreoretinal Lymphoma (PVRL) — a rare and life-threatening retinal cancer. This SPA indicates FDA’s concurrence with Aldeyra’s proposed clinical trial design. The company plans to conduct a randomized trial comparing one vs. eight intravitreal injections of ADX-2191 to evaluate cancer cell clearance. ADX-2191 is a vitreous-compatible, preservative-free methotrexate formulation, already granted orphan drug designation for PVRL and retinitis pigmentosa. The clinical trial is scheduled to begin in H2 2025.
• Mabwell’s subsidiary T-mab enters into an agreement with Qilu Pharma for Albipagrastim alfa for injection
Mabwell’s subsidiary T-mab has entered into a licensing agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection, a next-generation long-acting G-CSF fusion protein used to reduce febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy. The agreement grants Qilu exclusive rights to develop, manufacture, and commercialize the drug in Greater China, with T-mab receiving up to RMB 500 million in upfront and milestone payments, plus double-digit royalties on net sales. Albipagrastim alfa is built using albumin fusion platform technology, making it a more stable and longer-acting alternative to PEG-G-CSF.
• BioPorto initiates commercialization of ProNephro AKI for diagnostic use in US
BioPorto A/S, a Denmark-based in vitro diagnostics company, has begun the US commercialization of its ProNephro AKI (NGAL) diagnostic test. The test is used for risk stratification of moderate-to-severe acute kidney injury (AKI) in patients aged 3 months to 21 years. This milestone follows the receipt of the first US purchase order via BioPorto’s distribution partnership with Roche Diagnostics. This marks a key commercial step in BioPorto’s expansion strategy for kidney diagnostics.
• Bavarian Nordic initiates clinical trials of mpox vaccine in infants and pregnant women-
Bavarian Nordic A/S has initiated two clinical trials to evaluate the safety and immunogenicity of its MVA-BN (Jynneos/Imvanex/Imvamune) mpox and smallpox vaccine in vulnerable populations—infants under 2 years of age and pregnant or breastfeeding women. Conducted in the Democratic Republic of Congo, the trials will enroll 344 infants and 359 women, respectively. These studies are part of the PregInPoxVac project, led by universities in Antwerp and Kinshasa, with support from partners in Kenya and Italy. Funded by the European Union’s EDCTP3 and CEPI, the trials aim to generate essential data to support a label expansion of the MVA-BN vaccine. Additional trials in children aged 2–11 are also underway, with results expected in Q3 2025.
• Bayer extends partnership with Tsinghua University to accelerate pharmaceutical research in China-
Bayer and Tsinghua University (THU) announced that they have extended their research collaboration of 16 years by an additional three years, to further accelerate the translation of scientific research into drug discovery and development across the pharmaceutical value chain. The extended agreement will focus on joint research projects targeting key therapeutic areas, such as oncology, cardiovascular and renal diseases, neurology and rare diseases, as well as immunology. This long-term research alliance underscores Bayer’s continued commitment to investing in healthcare innovation in China and reinforces its goal for continued growth in this key market.
• Biocon Biologics collaborates with National Cancer Society Malaysia to expand affordable access to biosimilars-
Biocon Biologics has entered into a partnership with the National Cancer Society of Malaysia (NCSM) to launch a Patient Assistance Programme (PAP) aimed at improving access to affordable biosimilars for underserved cancer patients in Malaysia. Under this collaboration, Biocon will supply key oncology biosimilars—trastuzumab, pegfilgrastim, and bevacizumab—while NCSM will manage patient enrolment and distribution. The initiative begins with bTrastuzumab for patients facing treatment delays due to financial constraints. The Memorandum of Understanding (MoU) was signed during the National Cancer Congress Malaysia 2025, reinforcing Biocon’s commitment to inclusive, patient-centric care.
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• Bio-Thera Solutions & SteinCares expand partnership to commercialize biosimilars to treat inflammatory diseases across Latin America-
Bio-Thera Solutions Ltd. (China) and SteinCares (Latin America) have expanded their partnership to commercialize a proposed biosimilar of dupilumab across Latin America. This marks the fourth collaboration between the two companies, aiming to increase access to cost-effective therapies for chronic inflammatory diseases. Under the agreement, Bio-Thera will handle development and supply, while SteinCares manages registration and commercialization.
• EMA releases new guidelines on inclusion of pregnant and breastfeeding individuals in clinical trials-
The European Medicines Agency (EMA) has released for public consultation a new guideline providing recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials. The goal is to ensure developers generate robust clinical data in those populations, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines. It highlights that in principle, including pregnant and breastfeeding people in clinical trials should be considered for all medicines intended for people who can potentially give birth to children.
Domestic Pharma News
• Torrent Pharma to acquire controlling stake in JB Chemicals & Pharmaceuticals-
Torrent Pharmaceuticals has announced the acquisition of a controlling stake in JB Chemicals & Pharmaceuticals Ltd from investment firm KKR for an equity valuation of ₹25,689 crore. The deal, to be executed in phases, includes a cash purchase of 46.39% equity, a mandatory open offer to public shareholders, and plans to merge JB Pharma into Torrent. The acquisition will strengthen Torrent’s presence in chronic therapies and expand its international CDMO (contract development and manufacturing organization) capabilities.
• Tripura Drugs Control Department launches orientation training program for pharmacists and retail chemists –
The Tripura Drug Control Department has launched an orientation training program for pharmacists and retail chemists to enhance regulatory compliance and ethical dispensing practices. Under the leadership of State Drug Controller Kanchan Sinha, the department has modernized its enforcement systems, implemented tablet-based inspections, and upgraded the State Drugs Testing Laboratory. Efforts to curb misuse of narcotics and antibiotics have led to significant enforcement actions. Additionally, Tripura’s Pharmaceutical Price Monitoring and Resource Unit have been recognized as the best-performing unit for two consecutive years.
• Novo Nordisk launches Wegovy for obesity and heart risk management in India
Novo Nordisk has introduced Wegovy (semaglutide) in India—the country’s first once-weekly injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) for long-term weight management and cardiovascular risk reduction. Wegovy acts on brain regions that regulate appetite, helping reduce hunger and food cravings while improving insulin resistance. India-specific pricing starts at ₹17,345 for initial doses. The drug, backed by phase III trials on 3,500 Indian patients, comes in five strengths via an easy-to-use pen device.
• FMRAI demands withdrawal of order restricting MRs from Central government hospitals for sales promotion
The Federation of Medical and Sales Representatives’ Association of India (FMRAI) has requested the withdrawal of a government order restricting medical representatives from visiting Central Government hospitals for sales promotion. Issued by the Directorate General of Health Services (DGHS), the order advises sharing product updates digitally. FMRAI argues the move harms the pharmaceutical industry, affects over 3 lakh sales personnel, and wrongly implies unethical practices. The federation also highlighted its role in pushing for the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) to become legally binding.
• SCRMP to hold International Conclave 2025 on August 9 at Karnataka-
The Society of Clinical Research and Medical Professionals (SCRMP) will host its International Conclave 2025 on August 9 in Kalaburagi, Karnataka, in partnership with HKE Society’s Institute of Pharmaceutical Sciences. Themed “The Future of Clinical Research: Digital Transformation and Data-Driven Decisions,” the event will include expert panels, youth discussions, and journal launches. Key highlights are the release of three new academic journals and the promotion of international collaboration in clinical research and pharmacovigilance.
• Regulators ask NITI Aayog to establish a Task Force to counter growing menace of counter feitdrugs-
Regulators have urged NITI Aayog to form a national Enforcement Task Force, led by a senior Indian Police Service (IPS) officer, to combat rising counterfeit drug cases. The proposal cites a 50% increase in fake medicines and calls for urgent recruitment of drug inspectors, mandatory Quick Response (QR) codes, and stricter track-and-trace systems. A joint effort between states and the Central Drugs Standard Control Organization (CDSCO) has been recommended, along with nationwide public awareness campaigns.
• Telangana DCA initiates action against indiscriminate antibiotic sales, issues advisory to public-
The Telangana Drugs Control Administration (DCA) has launched a special inspection drive targeting 193 medical shops for the illegal sale of antibiotics without prescriptions, missing pharmacists, and failure to maintain required drug registers. This crackdown aims to curb antimicrobial resistance (AMR), which is a growing global health crisis. The DCA issued an advisory warning that over-the-counter antibiotic sales are punishable under the Drugs and Cosmetics Act, 1940, and stressed the need for public awareness and strict regulatory compliance to combat AMR.
Innovations
• Navamedic: First approval of the medical device OraFID as primary package for a pharmaceutical product-
Navamedic, a Nordic pharmaceutical company, has received regulatory approval for OraFID, a first-of-its-kind medical device approved as a primary packaging and dispensing system for a pharmaceutical product. Approved by the Swedish Medical Products Agency and supported by 9 other European countries, OraFID is a fully mechanical device that accurately dispenses minitablets, enabling precise dosing—especially crucial for treatments with narrow therapeutic windows. OraFID will be used with Flexilev, Navamedic’s drug for Parkinson’s disease, and is expected to launch in the Nordic markets in October 2025.
• Tracky unveils India’s first bluetooth-connected continuous glucose monitor for preventive healthcare-
Tracky, a healthtech brand by DrStore Healthcare Services, has officially launched its flagship product, positioned as India’s first Bluetooth-enabled Continuous Glucose Monitor (CGM). According to the company, the device is set to transform diabetes care and preventive health management in the country. With the launch of its new CGM, Tracky aims to help individuals manage diabetes through real-time insights and precision monitoring. The state-of-the-art device integrates modern sensor technology with a Bluetooth-enabled transmitter and a mobile app, offering a future-ready solution focused on innovation, affordability, and accessibility for the Indian population.
• DDMM Heart Institute installs real-time cardiac view recognition ultrasound system-
The Dharmsinh Desai Memorial Methodist (DDMM) Heart Institute in Nadiad has become the first hospital in western India to install Siemens Healthineers’ Acuson Origin—an artificial intelligence-powered real-time cardiac view recognition ultrasound system. This advanced technology enhances diagnostic precision in echocardiography and reduces dependency on electrocardiograms, thereby improving patient comfort and clinical accuracy. The new system supports comprehensive cardiovascular imaging across structural heart, vascular, electrophysiological, and pediatric procedures.
• Abbott introduces lab-based blood test to help evaluate mild traumatic brain injury-
Abbott has launched a laboratory-based blood test in India to evaluate mild traumatic brain injury (mTBI), commonly known as concussion. The test runs on Abbott’s Alinity i and Architect i1000SR instruments, already present in facilities like Apollo Hospitals and Neuberg Supratech Laboratory. Delivering results in just 18 minutes, it measures two key biomarkers—ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP)—to assess brain injury. The test may reduce the need for computed tomography (CT) scans by up to 40%, saving time and minimizing radiation exposure. With nearly one million cases annually in India, this tool offers timely diagnosis and better outcomes, especially in areas with limited CT access.
• START Launches Digital Hub to Expand Access to Cancer Trials-
The START Center for Cancer Research, known as the world’s largest early-phase community-based cancer trial network, has launched the START Hope Hub—a new digital platform aimed at enhancing access to oncology clinical trials. The platform connects patients, caregivers, referring oncologists, and advocacy groups to over 720 cancer clinical trials, offering streamlined trial matching, resource navigation, and live support. It supports both patients and physicians by making information accessible and actionable.
• Biocytogen secures Japanese patent for RenMab platform; expands global patent portfolio for RenMice fully human antibody-
Biocytogen Pharmaceuticals (Beijing) Co Ltd, a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, announced that the key technology of its independently developed RenMab fully human antibody mouse platform has been granted an invention patent by the Japan Patent Office. This milestone marks a significant step in strengthening the global intellectual property portfolio of the RenMice fully human antibody platform family. It underscores the continued advancement of Biocytogen’s comprehensive global patent strategy and highlights the innovation and international recognition of the company’s proprietary technologies.
• Amazon India offers at-home health diagnostics service with sample collection in less than 60 minutes & lab results 6 hours across 6 cities-
Amazon India has launched “Amazon Diagnostics,” offering at-home diagnostic services with sample collection in under 60 minutes and digital lab reports within 6 hours for routine tests. The service, launched in partnership with accredited provider Orange Health Labs, is currently available in Bengaluru, Delhi, Gurgaon, Noida, Mumbai, and Hyderabad across 450+ PIN codes. Integrated within the Amazon app, the service features real-time slot booking, map-based address validation, and secure access to reports. This marks a major step in Amazon’s broader healthcare vision under ‘Amazon Medical,’ complementing its existing offerings in teleconsultation and pharmacy services.
• AIxMed, Lumea ink partnership to enhance digital pathology platform with AI-powered urine cytology solution
AIxMed and Lumea have announced a partnership to integrate AIxMed’s AI-powered urine cytology tool, AIxURO, into Lumea’s US FDA-cleared digital pathology platform. AIxURO enhances bladder cancer diagnostics by identifying atypical cells using The Paris System, aiming to reduce invasive procedures and improve workflow efficiency. This integration strengthens Lumea’s cancer diagnostics capabilities in the urology sector, combining AIxMed’s expertise in computational cytology with Lumea’s established pathology ecosystem.
• New artificial intelligence-powered service launched to transform cancer detection and care-
A new AI-driven radiology analysis platform has been launched by The Royal Marsden NHS Foundation Trust in collaboration with NTT DATA and CARPL.ai, with funding from the NIHR. The service aims to improve cancer detection and diagnosis by applying artificial intelligence to medical imaging for cancers such as lung, breast, brain, sarcoma, and prostate. It provides a scalable research environment to test AI models in real clinical settings, with the goal of enhancing accuracy, treatment planning, and patient outcomes across the NHS.
• Micropep and Corteva announce research collaboration to co-develop next-generation peptide-based biocontrol solutions-
Micropep Technologies, a global leader in micropeptide technology for sustainable crop protection, has partnered with Corteva, Inc., a global pure-play agriculture technology company, to launch a multi-year research and development collaboration through the Corteva Catalyst platform. The focus is on co-developing next-generation peptide-based biocontrol solutions. Corteva, which invested in Micropep in 2024, will hold exclusive global rights to apply peptides from a defined library across biocontrol and biofungicide applications. This agreement marks the first major industry validation of Micropep’s proprietary Krisalix AI discovery platform, aimed at rapidly identifying bioactive peptides for environmentally friendly crop protection.
• Apollo Cancer Centres launches ‘CanWin’- a cancer support group for survivors of the disease-
Apollo Cancer Centers (ACCs) has launched ‘CanWin’, a cancer support group for survivors, caregivers, patients, oncologists, and volunteers to connect in a compassionate space. Introduced during National Cancer Survivors Month, this brand-agnostic platform aims to provide a safe environment to talk, listen, learn, and heal. ‘CanWin’ reflects the ideas of strength (CAN) and determination (WIN). Cancer winners from Bengaluru shared how the journey revealed hope and inner courage. The initiative emphasises that healing goes beyond treatment, blending emotional resilience with medical care.
• HeartSciences receives US FDA breakthrough device designation for its AI-ECG algorithm for detecting aortic stenosis-
HeartSciences Inc, an artificial intelligence-powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, announced that the US Food and Drug Administration has granted Breakthrough Device designation for its Aortic Stenosis ECG algorithm. Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Aortic Stenosis is a serious and widespread condition. The AI-ECG algorithm offers a powerful diagnostic solution designed for seamless integration with Hospital EHR systems.
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• UK MHRA launches new digital hub in Leeds to drive innovation and regional growth-
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new digital hub in Leeds as part of its national strategy to enhance digital capabilities, promote regional growth, and modernize healthcare regulation. Chosen for its strong digital health ecosystem and academic base, Leeds will serve as a key location for advancing data science, software development, and digital delivery. The hub will support closer collaboration with NHS bodies, tech companies, and universities, while creating around 30 highly-skilled roles in its first phase. This initiative aligns with the UK government’s “Places for Growth” and “Plan for Change” strategies, aiming to decentralize innovation and improve patient outcomes through tech-driven regulation.
Trends
• WHO outlines recommendations to protect infants against respiratory syncytial virus
The World Health Organization (WHO) has released its first position paper on immunization against respiratory syncytial virus (RSV), a major cause of respiratory illness in children under five. RSV leads to approximately 100,000 deaths and 3.6 million hospitalizations annually, with the majority occurring in infants under six months. WHO now recommends two preventive options: (1) a maternal vaccine (RSVpreF) administered in the third trimester of pregnancy, and (2) a long-acting monoclonal antibody (nirsevimab) given to infants at birth or during early health visits. Both approaches aim to protect newborns during their most vulnerable months and are expected to dramatically reduce RSV-related hospitalizations and deaths worldwide.
• Macquarie University’s new study shows DNA ‘glue’ could help prevent and treat age related disorders
Researchers at Macquarie University have identified a protein, Protein Disulphide Isomerase (PDI), that acts like a “DNA glue,” helping repair age-related Deoxyribonucleic Acid (DNA) damage in brain cells. This breakthrough could pave the way for new gene therapies targeting neurodegenerative diseases like Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and Motor Neuron Disease (MND). The study shows PDI improves DNA repair in lab and animal models, and researchers are now using messenger Ribonucleic Acid (mRNA)-based delivery systems to develop potential treatments.
• WHO issues new guidance on expanding midwifery-led care
The World Health Organization (WHO) has released new global guidance to help countries adopt midwifery-led care models that prioritize trusted midwife-patient partnerships through pregnancy, childbirth, and postnatal stages. Citing research that suggests over 60% of maternal and newborn deaths can be prevented with universal access to skilled midwives, WHO outlines approaches including continuity of care, midwife-led birth centers, and community-based delivery. The guidance emphasizes regulatory support, strategic funding, and ethical collaboration with healthcare teams to reduce unnecessary interventions and improve maternal outcomes worldwide.
Law and Order Briefs
• India initiates anti-dumping probe on TPU-based paint protection films from China-
The Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping investigation into imports of thermoplastic polyurethane (TPU)-based paint protection films from China. This follows a complaint by Garware Hi-Tech Films Limited under the Customs Tariff Act, 1975. The films, widely used in healthcare and pharma sectors, are alleged to be dumped in India at unfair prices, causing injury to domestic industry. Garware, the sole domestic producer, claims the imported products are identical to its own. The DGTR found that imports from China have increased significantly, leading to price suppression and financial losses. Based on prima facie evidence, the authority has started the probe to assess the extent of dumping and determine the appropriate anti-dumping duty to protect domestic industry.
• Delhi HC seeks regulator’s reply after PIL questions Ozempic, Mounjaro nod
The Delhi High Court has directed the Central Drugs Standard Control Organisation (CDSCO) to respond to a Public Interest Litigation (PIL) questioning the approval process for semaglutide (marketed as Ozempic) and tirzepatide (marketed as Mounjaro). The PIL raises concerns over the availability of these anti-obesity drugs in India without clear safety data or transparent clinical trials. The court has asked the regulator to consult medical experts and pharmaceutical manufacturers. Notably, Ozempic is reportedly accessible via the grey market despite not being officially approved for sale in India.
• CBI searches premises of Pharmacy Council of India chief in corruption case.
The CBI has booked Pharmacy Council of India President Montu M. Patel for alleged corruption and irregularities in pharmacy college approvals, conducting searches at his premises. Investigations revealed manipulated inspections, favoritism towards specific institutions, and electoral manipulation before Patel’s presidential election. Approvals were granted despite negative reports, with evidence of bribery and infrastructural deficiencies in several colleges across multiple states.
• Compounding of Offences Rules to resolve minor issues pragmatically with no prolonged legal proceedings.
The Government of India has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, aimed at resolving minor regulatory violations without resorting to prolonged court proceedings. These rules, effective from April 24, 2025, allow manufacturers to compound offences through penalties rather than face criminal prosecution. Industry leaders have welcomed the reform as a practical measure to ensure compliance and reduce litigation. However, experts also caution against potential misuse, emphasizing the need for judicious application to maintain public trust and drug safety.