Home Blog

FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia

Dose Daily News Bureau
-
0
FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY® (nipocalimab-aahu) as the first therapy specifically indicated for the treatment of warm autoimmune hemolytic anemia (wAIHA). The approval extends to adult and pediatric patients aged 12 years and older who are currently or previously treated with corticosteroids.

wAIHA is a rare, antibody-driven condition that causes premature destruction of red blood cells. IMAAVY functions as an immunoselective neonatal Fc receptor (FcRn) blocker, engineered to selectively reduce disease-driving IgG autoantibodies while preserving essential B-cell immune function.

The FDA decision is supported by robust data from the pivotal Phase 2/3 ENERGY clinical study. In the trial, approximately three times as many patients treated with the approved dose of IMAAVY achieved a durable hemoglobin response compared to those on placebo at 24 weeks, demonstrating meaningful and sustained disease control.

“Today’s announcement marks the second approval for IMAAVY and is an extraordinary milestone for people living with warm autoimmune hemolytic anemia, an underserved community that has waited far too long for an FDA-approved treatment,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson. “As the first approved therapy for wAIHA, IMAAVY has the potential to redefine disease management, particularly for people with uncontrolled disease.”

This regulatory milestone strengthens the clinical utility of FcRn-targeted therapies across serious antibody-driven autoimmune conditions. IMAAVY provides a much-needed, targeted therapeutic option designed to address the underlying mechanism of hemolytic anemia and improve long-term outcomes for patients navigating this challenging disorder.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

FDA Approves World’s First Combined Glucose-Ketone Wearable Monitor

Dose Daily News Bureau
-
0
FDA Approves World’s First Combined Glucose-Ketone Wearable Monitor

The U.S. Food and Drug Administration has granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, approved for use in patients aged two and above with diabetes. This marks a significant milestone: it is the first FDA-cleared wearable in the country capable of continuously tracking ketone levels, and the first device anywhere to combine real-time glucose and ketone monitoring within one wearable sensor.

CDRH Director Michelle Tarver highlighted the device’s potential to give families and clinicians a critical head start against dangerous ketone spikes, framing the clearance as a meaningful advance in patient safety.

Roughly 40 million Americans currently manage diabetes, with an estimated 2.1 million living with type 1 diabetes, a population particularly vulnerable to diabetic ketoacidosis (DKA) — a fast-developing, potentially fatal complication triggered by excess ketone production. Previously, ketone testing relied on isolated point-in-time readings. The Libre Duo 10 Day instead samples interstitial fluid every 60 seconds across its 10-day wear cycle, transmitting trend data to a paired smartphone and issuing alerts when ketone levels climb toward risk thresholds.

Supporting clinical evidence came from six studies spanning over 600 participants, confirming the sensor’s ability to detect meaningful ketone shifts — including early rises preceding DKA onset — alongside reliable glucose tracking.

The product received Breakthrough Device designation ahead of its review and was authorized through the De Novo pathway, alongside newly established special controls governing labeling and performance standards for this novel device category.

This is a sensitive health-related topic — if you or someone you know needs personalized guidance on diabetes management or DKA risk, please consult a healthcare provider.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Lundbeck and EVERSANA Enter Strategic Partnership to Advance AI-Powered Commercialization Across U.S. Operations

Dose Daily News Bureau
-
0
Lundbeck and EVERSANA Enter Strategic Partnership to Advance AI-Powered Commercialization Across U.S. Operations

Lundbeck, a global biopharmaceutical leader focused exclusively on brain health, and EVERSANA®, a leading global provider of commercial services to the life sciences sector, have announced a strategic partnership to scale AI-powered commercialization across Lundbeck’s U.S. commercial organization.

​The expanded collaboration builds on initial successful deployments and broadens Lundbeck’s integration of EVERSANA’s AI Agency platform. By leveraging agentic AI orchestration, workflow automation, and human oversight, the platform establishes an operating model designed to accelerate strategic planning, content generation, and omnichannelengagement while strictly adhering to life sciences governance and medical, legal, and regulatory (MLR) compliance.

​Under the partnership, Lundbeck will scale these capabilities across multiple key commercial functions, including marketing, medical communications, market access, and media operations. The initiative directly supports Lundbeck’s “Focused Innovator” strategy and ambition to build “bionic capabilities” combining artificial intelligence with deep human domain expertise to streamline operations and enhance speed-to-market.

​Executive leadership from both organizations emphasized that the alliance moves beyond isolated AI pilot programs into enterprise-level commercial execution. By embedding compliance and scientific rigor into AI workflows, the partnership aims to enhance operational agility, reduce cycle times, and ultimately deliver greater value and essential therapies to patients living with neurological and psychiatric disorders.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Montage Laboratories Commences Construction of Manufacturing Unit 3 to Expand Production Footprint

Dose Daily News Bureau
-
0
Montage Laboratories Commences Construction of Manufacturing Unit 3 to Expand Production Footprint

Montage Laboratories Pvt. Ltd., a manufacturer of pharmaceutical formulations, has performed the Bhoomi Pujan(groundbreaking ceremony) for its upcoming manufacturing facility, Unit 3. The milestone marks a new phase in the company’s infrastructure and capacity expansion roadmap.

​The new unit is designed to enhance Montage Laboratories’ manufacturing capabilities and strengthen its production capacity to meet the growing domestic and global demand for quality-driven formulations. The facility will operate under Current Good Manufacturing Practice (cGMP) standards, expanding on the company’s existing operations in Himmatnagar.

​Company leadership, stakeholders, and team members attended the groundbreaking ceremony. The management highlighted that this strategic investment is a vital step toward scaling up operations, enhancing technical infrastructure, and reinforcing the company’s long-standing commitment to delivering high-quality, affordable healthcare solutions.

​Construction and development work for Unit 3 will commence immediately, with further details on production lines and project timelines to be announced as development progresses.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

AIIA Rolls Out “Garbhini Mitra” Programme to Widen Community-Level Maternal Support Through Ayurveda

Dose Daily News Bureau
-
0
AIIA Rolls Out “Garbhini Mitra” Programme to Widen Community-Level Maternal Support Through Ayurveda

The All India Institute of Ayurveda (AIIA) in New Delhi, an autonomous body under the Ministry of Ayush, has launched a new skill-development course called Garbhini Mitra for the 2026–27 academic session. The programme is designed to build a workforce capable of guiding women through pregnancy and the weeks that follow, blending traditional Ayurvedic principles with practical, community-facing training.

Structured around the classical frameworks of antenatal, postnatal and pre-conceptional care described in Ayurvedic texts, the course runs as a six-month, in-person programme held on weekday afternoons. Trainees will work through trimester-specific nutrition planning, safe lifestyle and yoga practices, emotional support techniques for labour, newborn massage, and foundational life-support skills, alongside modules on infection control, biomedical waste handling and workplace safety.

Based at AIIA’s Sarita Vihar campus, each batch will accept 20 trainees. Applicants need to have cleared Class 12 from a recognised board and be at least 18 years old; those still awaiting their results this year can apply provisionally. Graduates of the programme are expected to find placements as maternal wellness assistants and antenatal support workers across Ayush centres, maternity clinics, NGOs and community health initiatives.

AIIA has been clear that the initiative is meant to sit alongside, not substitute, standard clinical antenatal care — essential check-ups, lab tests and blood pressure or haemoglobin monitoring remain unchanged. Instead, trained Garbhini Mitras are positioned to spot early warning signs at the community level and direct women toward timely medical attention.

Written By: Sayan Das

Graphics by: Pramit Hazra

GSK’s Hibsago Becomes World’s First Approved Functional Cure for Chronic Hepatitis B

Dose Daily News Bureau
-
0
GSK’s Hibsago Becomes World’s First Approved Functional Cure for Chronic Hepatitis B

GSK has secured its first global regulatory approval for Hibsago(bepirovirsen), marking the debut of a functional cure option for chronic hepatitis B (CHB) anywhere in the world. Japan’s Ministry of Health, Labour and Welfare cleared the antisense oligonucleotide for adults who have completed at least six months of prior nucleoside/nucleotide analogue therapy and meet specific viral marker criteria.

The approval carries significant weight for Japan, where nearly a million people live with CHB and the disease drives roughly 4,000 deaths each year. Review was fast-tracked under the country’s SENKU pathway, reserved for therapies addressing serious unmet medical needs.

Backing the decision, pooled results from the B-Well Phase III program showed a 19% functional cure rate among patients with baseline HBsAglevels at or below 3000 IU/ml — a sharp contrast to the roughly 1% typically seen with standard antiviral suppression alone. Among a narrower subgroup with lower baseline antigen levels, cure rates climbed to 26%. Functional cure is defined as sustained loss of detectable virus and surface antigen for six months after stopping treatment, meaning patients could potentially be freed from indefinite drug dependence.

GSK, which licensed the compound from Ionis, said filings are progressing in additional markets, including the United States, with outcomes anticipated in coming months. Company leadership described the milestone as a turning point for hepatitis B care and its broader liver-disease pipeline, which also spans MASH and alcohol-related liver conditions.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Fortis Healthcare Launches Lung Failure Clinics in New Delhi to Enhance Advanced Respiratory and Transplant Care

Dose Daily News Bureau
-
0
Fortis Healthcare Launches Lung Failure Clinics in New Delhi to Enhance Advanced Respiratory and Transplant Care

Fortis Healthcare has announced the launch of dedicated Lung Failure Clinics at its Shalimar Bagh and Vasant Kunj facilities in New Delhi. The initiative establishes a specialized, multidisciplinary care model to provide end-to-end evaluation, targeted therapies, and transplant pathways for patients living with progressive and end-stage respiratory diseases.

​The clinics are designed to manage complex conditions such as Interstitial Lung Disease (ILD), severe Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, and pulmonary hypertension. Led by experienced teams in pulmonology, respiratory critical care, and lung transplant surgery, the centersintegrate advanced diagnostics, interventional bronchoscopy, structured pulmonary rehabilitation, non-invasive ventilation, and nutritional counselling under one roof.

​For individuals with irreversible disease progression, the clinics offer early eligibility screening, pre-transplant counselling, and post-transplant follow-up protocols. The critical need for early clinical intervention was underscored by a recent clinical milestone at Fortis Hospital, Shalimar Bagh, where a 29-year-old physiotherapist with deteriorating end-stage ILD received a life-saving double-lung transplant following timely multidisciplinary referral.

​Medical specialists noted that environmental pollution, tobacco use, occupational risks, and chronic infections are contributing to a growing burden of respiratory illnesses across the National Capital Region. Many patients seek tertiary intervention only after advanced functional impairment has set in. By operating structured outpatient services including specialized sessions every Tuesday and Friday at Fortis Shalimar Bagh the new clinics aim to bridge this critical gap, facilitating earlier referral, slowing disease progression, and improving survival outcomes for patients with severe lung failure.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Symbiotec Pharmalab Announces ₹1,757 Crore IPO to Fuel Biopharma Growth

Dose Daily News Bureau
-
0
Symbiotec Pharmalab Announces ₹1,757 Crore IPO to Fuel Biopharma Growth

Symbiotec Pharmalab, a leading research and development-driven pharmaceutical and biotechnology player, has announced details of its ₹1,757 crore Initial Public Offering (IPO). The public issue features a primary fundraise of ₹150 crore, which the company intends to deploy strategically toward debt reduction to strengthen its financial foundation.

​Operating at the intersection of organic chemistry and fermentation-based biotechnology, Symbiotec is a global leader in steroid and hormone Active Pharmaceutical Ingredients (APIs). The company provides a vertically integrated platform utilizing plant-based phytosterols (soybean-derived sterols) as a primary starting material, ranking as the sole manufacturer in India and the sixth globally with this capability. Symbiotecoffers a portfolio of approximately 60 molecules to over 250 global clients across North America, the European Union, Japan, and domestic markets, supported by more than 50 US DMFs and 25 CEP filings.

​Over the past three to four years, Symbiotec has invested more than ₹800 crore via internal accruals and debt to build manufacturing and technological capabilities. As of March 2026, the company holds approximately ₹380 crore in net debt, which will be substantially reduced using the primary proceeds from the offering.

​Under its strategic roadmap, dubbed “Symbiotec 2.0,” the company is commercializing two high-value growth engines: complex injectable specialty pharmaceuticals and large-scale fermentation-based contract development and manufacturing organization (CDMO) services. Management anticipates these multi-year capital investments will drive commercial revenue in the upcoming quarters, effectively diversifying the company’s product base, mitigating customer concentration risk, and broadening its global biopharmaceutical footprint.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Pharmacy Council of India Introduces M.Pharm Specialisation in Medical Devices

Dose Daily News Bureau
-
0
Pharmacy Council of India Introduces M.Pharm Specialisation in Medical Devices

The Pharmacy Council of India (PCI) has officially notified an amendment to the Master of Pharmacy (M.Pharm) Course Regulations, introducing Medical Devices as a new postgraduate specialisation across Indian universities starting from the 2027–28 academic year. Delivered in English under the Credit-Based Semester System (CBSS), the four-semester, two-year programme is designed to equip pharmacy graduates with specialized technical, manufacturing, and regulatory expertise to meet the rapidly expanding demands of the medtech sector.

​The curriculum provides structured training across academic theory, practical laboratory work, and advanced research. The first semester covers core fundamentals, including medical device technology, regulatory affairs, manufacturing processes, biocompatibility, and toxicology, accompanied by practical laboratory sessions. The second semester broadens into emerging innovations, quality control, risk assessment, safety management, clinical evaluation, market access, intellectual property rights (IPR), and entrepreneurship, alongside seminars and advanced lab work. The final two semesters focus entirely on research methodology, biostatistics, journal clubs, and intensive dissertation projects.

​To ensure high standards of practical training, the regulations permit students to conduct research either at approved on-campus facilities or through formal Memorandums of Understanding (MoUs) with recognized external partners. These eligible partner institutions include CDSCO-approved manufacturers, nationally recognized device testing laboratories, Institutes of National Importance, Indian Pharmacopoeia Commission materiovigilance centres, accredited Clinical Research Organisations (CROs), and specialized R&D facilities. This strategic regulatory addition establishes a vital academic bridge between traditional pharmacy training and the modern medical device industry.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Australia on Alert: The Rising Threat of H5 Bird Flu

Dose Daily News Bureau
-
0
Australia on Alert: The Rising Threat of H5 Bird Flu

A fur seal washed up at Beachport in South Australia in late August. Nothing appeared obviously wrong with the animal at first, but testing by CSIRO’s Australian Centre for Disease Preparedness confirmed H5 bird flu. It was the first confirmed detection of H5 bird flu in a mammal in Australia, with authorities believing the infection was likely linked to exposure to infected wild birds or contaminated environments.

The Agriculture Minister said the development was concerning but not unexpected as the virus continues to circulate in wild birds. Wildlife experts have also warned that the virus could have a serious impact on seal populations, as has been seen in some overseas outbreaks.

It all started back in June with detections in migratory seabirds in Western Australia. Since then, the virus has been detected in wild birds across several states, with South Australia among the hardest-hit areas. More than a thousand greater crested terns have died on islands in South Australia, while little penguins and other native species have also been affected.

Authorities began catching and vaccinating little penguins on Phillip Island in mid-August. The vaccination requires two doses, so it is not practical to vaccinate every wild bird. Instead, the program is focused on protecting key populations and managed colonies considered particularly vulnerable. Hundreds of native species could be at risk as the virus continues to spread, although vaccination is only one part of the response.

Private veterinarians and wildlife carers are also facing increasing pressure, with new precautions for handling potentially infected birds and greater use of personal protective equipment. Veterinary and wildlife organisations have encouraged clinics to continue supporting affected wildlife while following appropriate biosecurity measures. The situation is placing significant physical and emotional pressure on those working on the frontline.

For everyone else, the advice is fairly simple: stay away from sick or dead birds and mammals, avoid touching them, note where they were found and report suspected cases through the appropriate emergency or wildlife authorities. Australia is now responding to the outbreak with surveillance, vaccination, testing and biosecurity measures, with the focus on acting quickly to limit its impact on wildlife.

Written by: Bimbita Kar

Graphics by: Pramit Hazra

123...48Page 1 of 48