Gland Pharma Secures USFDA Approval and 180-Day Exclusivity for Generic VYZULTA
Gland Pharma has announced that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%. This product is the generic version of VYZULTA Ophthalmic Solution, 0.024%, developed by Bausch and Lomb, Inc. It is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension—serious eye conditions that can lead to vision loss if left untreated.
As the first-to-file applicant for this generic product, Gland Pharma has secured exclusive marketing rights for 180 days in the U.S. market. This exclusivity provides a significant competitive advantage, allowing Gland Pharma to be the sole generic supplier during this period, with strong potential for increased revenue.
This FDA approval marks a key milestone in Gland Pharma’s U.S. growth strategy, reinforcing its presence in the American pharmaceutical market. It also highlights the company’s expanding portfolio of complex ophthalmic generics and injectable products. With a focus on delivering high-quality, cost-effective medicines to regulated markets, Gland Pharma continues to strengthen its position as a reliable supplier of U.S.-approved generics.
Gland Pharma Secures USFDA Approval and 180-Day Exclusivity for Generic VYZULTA
Gland Pharma has announced that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%. This product is the generic version of VYZULTA Ophthalmic Solution, 0.024%, developed by Bausch and Lomb, Inc. It is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension—serious eye conditions that can lead to vision loss if left untreated.
As the first-to-file applicant for this generic product, Gland Pharma has secured exclusive marketing rights for 180 days in the U.S. market. This exclusivity provides a significant competitive advantage, allowing Gland Pharma to be the sole generic supplier during this period, with strong potential for increased revenue.
This FDA approval marks a key milestone in Gland Pharma’s U.S. growth strategy, reinforcing its presence in the American pharmaceutical market. It also highlights the company’s expanding portfolio of complex ophthalmic generics and injectable products. With a focus on delivering high-quality, cost-effective medicines to regulated markets, Gland Pharma continues to strengthen its position as a reliable supplier of U.S.-approved generics.
Novartis to Acquire Regulus Therapeutics in Deal Worth Up to $1.7 Billion
Swiss pharmaceutical giant Novartis has announced an agreement to acquire Regulus Therapeutics in a deal valued at up to $1.7 billion.
Under the terms of the agreement, Novartis—through a subsidiary—will launch a tender offer to purchase all outstanding shares of Regulus at an initial price of $7.00 per share, totaling approximately $800 million. This offer represents a 108% premium over Regulus’ closing share price on April 29.
In addition to the upfront payment, Regulus shareholders will receive a contingent value right (CVR) of $7.00 per share, which will be payable if Regulus’ lead investigational drug, farabursen, secures regulatory approval. If realized, the full consideration of the deal would reach approximately $1.7 billion.
Farabursen is a novel microRNA inhibitor currently in development for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a serious inherited kidney disorder. The drug is designed to reduce cyst growth, slow kidney enlargement, and delay disease progression—addressing a significant unmet need in ADPKD treatment.
Novartis President Shreeram Aradhye highlighted the promise of farabursen, noting that current treatment options for ADPKD remain limited. “The team at Regulus has done meaningful foundational work with farabursen, and we look forward to exploring its full potential to offer a better solution for patients in need,” he said.
The acquisition is expected to close in the second half of 2025. Until then, Regulus will continue to operate independently. Upon completion, it will become an indirect, wholly owned subsidiary of Novartis.
Innovative Financing Model Expands Access to Radiotherapy in Africa
Access to life-saving radiotherapy remains severely limited across Africa, where high upfront equipment costs and a shortage of trained personnel continue to hinder progress. In response, a new pay-per-use financing model is being introduced to help bridge the gap in cancer treatment services.
Under this model, countries make an initial payment for radiotherapy equipment, with subsequent payments tied to actual usage for patient treatments. The approach allows healthcare systems to shift from purchasing standalone machines to acquiring a comprehensive solution that includes equipment, maintenance, and ongoing service.
To support this innovative model, MedAccess has partnered with Elekta to provide a volume guarantee. This guarantee helps mitigate financial risk by covering potential shortfalls in machine usage, should the governments of Kenya or Tanzania adopt the model. The goal is to ensure the machines remain sustainable and accessible, even if patient volumes fall short in the early stages.
Michael Anderson, CEO of MedAccess, described the partnership as a landmark initiative: “This is our first innovative finance product aimed at tackling a non-communicable disease. Our volume guarantee is helping unlock access to radiotherapy for underserved communities, ensuring patients receive the treatment they need.”
Elekta’s Chief Commercial Officer, Habib Nehme, echoed the sentiment, emphasizing the transformative nature of the model: “By working with MedAccess, we’re bringing advanced radiation therapy infrastructure to regions that need it most. This model allows us to extend care to more patients while maintaining quality and sustainability.”
Clinical oncologist Dr. Abeid Athman of Kenyatta University Teaching, Referral & Research Hospital (KUTRRH) highlighted the real-world impact: “Having more machines closer to where patients live will reduce travel and waiting times, directly improving survival outcomes. The right ratio of human resources and equipment will help us address systemic treatment delays.”
The need is urgent. According to the International Agency for Research on Cancer (IARC), Africa recorded 1.15 million cancer cases and over 750,000 deaths in 2022. That number is expected to more than double to 2.4 million cases by 2045. Radiotherapy plays a vital role in treating up to 70% of cancer patients, yet access remains far below global standards.
As of 2020, only 32 of 54 African countries had any radiotherapy capabilities. Tanzania, with a population of nearly 68 million, has just seven machines—compared to about 350 in the UK, which has a similar population. The International Atomic Energy Agency recommends one machine per 250,000 people, meaning Africa would need around 5,600 machines to meet demand.
By supporting an all-inclusive, pay-per-use approach, MedAccess and Elekta are opening a new chapter in cancer care for low- and middle-income countries. As Kenya, Tanzania, and others explore radiotherapy expansion plans, this model offers a strategic path toward greater accessibility and sustainability in cancer treatment.
Apollo Diagnostics Launches State-of-the-Art Digi-Smart Central Reference Laboratory
Apollo Diagnostics has inaugurated its advanced “Digi-Smart Central Reference Laboratory” (CRL) in the city, a fully automated facility designed to enhance diagnostic speed and accuracy. The new lab integrates five core diagnostic disciplines—Clinical Chemistry, Immunoassay, Serology, Haematology, and Haemostasis—into a seamless, tech-driven workflow.
Speaking at the launch, Dr. Prathap C. Reddy, Founder and Chairman of Apollo Hospitals, emphasized the critical role diagnostics play in guiding accurate medical decisions. Executive Vice-Chairperson Preetha Reddy added, “Seventy percent of what happens in clinical care depends on good diagnostics. It is the strongest arm of healthcare delivery.”
Joint Managing Director Sangita Reddy noted that the facility is initially equipped to process 25,000 samples per day, with plans to double this to 50,000 and later scale up to 100,000. She also shared Apollo’s plans to expand into clinical genomics, including comprehensive carrier screening for inherited diseases and broad cancer screening panels.
Suneeta Reddy, Managing Director of Apollo Hospitals Enterprise Limited, said the group is moving into high-end genomics, further strengthening its position in precision medicine.
The CRL will offer over 3,000 diagnostic tests, according to Sriram Iyer, CEO of Apollo Health and Lifestyle Limited. Leveraging automation and advanced analytics, the lab is expected to reduce turnaround time by 60%.
Mamta Soni, Chief of Laboratory Services at CRL, highlighted the use of advanced robotics, custom-built algorithms, and high-definition imaging to streamline operations, minimize errors, and boost efficiency.
The launch event was also attended by Madhu Sasidhar, President and CEO of Apollo Hospitals, marking a key milestone in Apollo’s mission to deliver cutting-edge, technology-driven diagnostics across India.
Odisha Launches ₹9,200 Crore Revamp of Major Hospitals to Strengthen Healthcare Infrastructure
In a landmark move to upgrade its healthcare system, the Odisha government has announced a ₹9,200 crore infrastructure overhaul for four key medical institutions. The initiative, approved during a high-level meeting chaired by Chief Minister Mohan Charan Majhi, represents one of the state’s largest healthcare investments to date.
VIMSAR Medical College, Burla: Allocated ₹1,594 crore, the hospital’s bed capacity will nearly double—from 1,485 to 2,861.
MKCG Medical College, Berhampur: ₹1,014.13 crore will fund the increase in beds from 1,583 to 2,033.
Rourkela Government Hospital: With ₹627.16 crore, the hospital’s capacity will grow from 437 to 763 beds.
Capital Hospital, Bhubaneswar: Receiving the largest investment of ₹5,958 crore, this facility will expand from 750 to 2,582 beds.
The comprehensive plan includes modern infrastructure upgrades, advanced diagnostic and treatment equipment, and a focus on elevating the quality of patient care.
This mega healthcare initiative follows Odisha’s earlier announcement to establish new government medical colleges in Bhadrak, Jagatsinghpur, Dhenkanal, and Nabarangpur. The state currently operates 12 medical colleges, with two more nearing inauguration. Funding for these colleges is drawn from the 2025–26 state budget, under a national 60:40 cost-sharing scheme with the central government.
During a recent address at the launch of Ayushman Bharat PM-JAY in Cuttack, CM Majhi emphasized the government's commitment to expanding the healthcare workforce. He highlighted the recruitment of 4,000 medical professionals in the last 10 months and announced plans to recruit an additional 5,000 doctors and dentists.
With these investments, Odisha aims to increase its total hospital bed capacity by 30% and significantly enhance access to specialised care, keeping pace with the healthcare needs of its growing population.
Centre Approves Medical College and SNM Hospital Expansion in Ladakh at ₹786 Crore
The Government of India has granted in-principle approval for the establishment of a new medical college in the Union Territory of Ladakh, along with a major expansion of the Sonam Norboo Memorial (SNM) Hospital in Leh. The combined cost of the two projects is estimated at ₹786 crore.
Chairman and Chief Executive Councillor of the Ladakh Autonomous Hill Development Council (LAHDC), Tashi Gyalson, congratulated the people of Ladakh on the Centre’s nod to set up the medical college at Spituk Pharka in Leh and upgrade SNM Hospital. He expressed deep appreciation to the Ministry of Finance and extended special thanks to Prime Minister Narendra Modi, Home Minister Amit Shah, and Union Health Minister JP Nadda for their visionary leadership and continued support in addressing Ladakh's long-standing healthcare needs.
Gyalson noted that the dual projects will significantly strengthen Ladakh’s healthcare infrastructure, improve access to quality medical services, and open new opportunities in medical education for local students. “This is a transformative milestone for healthcare and education in the region,” he stated.
In a related development, former Ladakh MP Jamyang Tsering Namgyal congratulated SNM Hospital and Dr. Lotus Gyalson for successfully performing the region’s first permanent pacemaker implantation. Sharing the news on X (formerly Twitter), he acknowledged the efforts of the medical team and the support of the Ayushman Bharat PM-JAY scheme in bringing advanced cardiac care to Ladakh.
FDA Approves Johnson & Johnson’s IMAAVY™ for Generalized Myasthenia Gravis
Johnson & Johnson has announced FDA approval for IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG) in adults and adolescents (12 years and older) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. The approval follows a Priority Review and marks a significant advancement in treating this chronic autoimmune neuromuscular disorder.
gMG is a debilitating condition marked by fluctuating muscle weakness, often affecting daily functions like speaking, swallowing, and breathing. Current treatment options are limited, and there is a strong need for therapies that provide long-term symptom control with a favorable safety profile. Anti-AChR and anti-MuSK antibodies are present in over 90% of antibody-positive gMG cases.
IMAAVY is an immunoselective therapy that reduces immunoglobulin G (IgG) levels, including harmful autoantibodies, without affecting broader immune functions. Its approval is based on results from the pivotal Vivacity-MG3 trial, which showed that IMAAVY plus standard care provided superior disease control over 24 weeks compared to placebo. Patients reported improved daily functioning and sustained symptom relief. Autoantibody levels dropped by up to 75% from the first dose, with benefits maintained for up to 20 months in an open-label extension study.
In the Vibrance pediatric study, IMAAVY also met its primary endpoint in adolescents (12–17 years), reducing IgG by 69% and improving MG-ADL and QMG scores. Safety profiles across adult and pediatric groups were consistent and well tolerated.
“This approval offers hope to patients facing unpredictable symptoms and limited options,” said Dr. Nicholas Silvestri, Professor of Neurology, University at Buffalo. Johnson & Johnson’s IMAAVY withMe support program will help ensure timely and affordable patient access in the U.S., with eligible insured patients possibly paying as little as $0 per infusion.
Global regulatory reviews of nipocalimab for gMG are ongoing, signaling broader access in the future.
Intuitive Partners with HSSC to Skill Emergency Healthcare Professionals in India
Intuitive, a global leader in minimally invasive care and robotic-assisted surgery, has announced a strategic collaboration with the Healthcare Sector Skill Council (HSSC) to strengthen India’s healthcare workforce by skilling emergency healthcare professionals. This initiative supports the Indian government’s Skill India mission, which focuses on bridging the gap between industry requirements and workforce capabilities through structured training programs.
Recognizing the critical need for skilled professionals in emergency care, the collaboration is focused on training Emergency Medical Technicians (EMTs) — vital frontline responders who deliver immediate medical care during emergencies. Currently, over 200 candidates from Delhi and Jharkhand are enrolled in a structured EMT training program under this initiative. The program aims to enhance their employability and create meaningful career opportunities in the healthcare sector.
“At Intuitive, we believe that a resilient healthcare infrastructure starts with skilled professionals,” said Rohitt Mahajan, Vice President and General Manager, Intuitive India. “Our partnership with HSSC represents a shared vision of empowering India’s healthcare workforce through innovation and education. By integrating our experience in robotic-assisted surgical training with HSSC’s expertise in skill development, we are contributing to better patient care across India.”
Intuitive has long prioritized education and training in the healthcare space, having developed comprehensive programs for its da Vinci robotic surgical systems. This collaboration expands that commitment into broader healthcare delivery by helping to equip EMTs with critical, real-world emergency response skills.
According to Gina Russo, Vice President, Global Public Affairs at Intuitive, “This initiative is another step in our global commitment to supporting healthcare professionals with the skills they need to improve outcomes. By addressing the increasing demand for trained personnel, we are contributing to improved healthcare delivery and more efficient patient care throughout the country.”
Ashish Jain, CEO of HSSC, emphasized the initiative’s alignment with national priorities: “Partnering with industry leaders like Intuitive allows us to create a sustainable, industry-aligned skilling ecosystem. We aim to address the demand-supply gap by providing specialized skills, hands-on training, and practical knowledge. This will not only strengthen India’s healthcare system but also elevate service quality and outcomes.”
The initiative aligns with the Skill India program’s mission of empowering youth with job-ready skills through skilling, re-skilling, and up-skilling. By preparing individuals with practical competencies, it ensures India’s healthcare workforce remains responsive to evolving patient and industry needs.
HemoSonics Wins 2025 Medical Device Network Excellence Award for Marketing Excellence
HemoSonics, LLC, a medical device company specializing in acute bleeding management, has been honored with the 2025 Medical Device Network Excellence Award in the Marketing category for its successful promotion of the Quantra Hemostasis System. This award celebrates the company’s outstanding efforts in conveying the value of its technology, fostering educational engagement within the healthcare community, and leading thought leadership in the field of blood management.
The Quantra Hemostasis System, which includes the Quantra Hemostasis Analyzer and QPlus and QStat Cartridges, delivers critical coagulation data to clinicians in under 15 minutes. This rapid turnaround supports timely, patient-focused decisions in high-risk surgical settings such as cardiovascular, trauma, liver transplantation, and orthopedic procedures. Using proprietary SEER Sonorheometry (Sonic Estimation of Elasticity via Resonance), the system analyzes the coagulation properties of whole blood through medical-grade ultrasound technology. Designed for ease of use, low maintenance, and operational efficiency, Quantra enables hospitals to standardize and streamline viscoelastic testing programs at the point of care.
HemoSonics’ marketing success stems from its multifaceted communication strategy. The company has leveraged targeted campaigns, webinars, social media engagement, and real-world case studies to highlight how the Quantra System enhances clinical outcomes and reduces unnecessary transfusions. Its efforts have positioned the Quantra as a transformative tool in hemostasis testing.
The company’s visibility has also been bolstered by recognition across major innovation platforms. The Quantra System was named to the 2024 TIME Best Inventions, Fast Company’s Most Innovative Companies (Medtech), the Edison Awards in the Point-of-Care and Therapeutic Solutions category, and the Deloitte Fast 500, which ranks the fastest-growing companies in North America.
Beyond product promotion, HemoSonics has built a strong reputation as a thought leader in blood management. Through opinion articles, podcast features, conference presentations, and earned media, the company’s leadership team has helped advance conversations around coagulation testing and patient blood management, while also gaining valuable insights to refine future marketing and R&D initiatives.
“We are committed to improving patient outcomes and hospital efficiency through the Quantra Hemostasis System,” said Bob Roda, President and CEO of HemoSonics. “Effective marketing and communication are vital to spreading awareness and driving adoption of our technology in hospitals nationwide.”
The Medical Device Network Excellence Awards, powered by GlobalData, evaluate data from over a billion sources to honor industry leaders across more than 200 countries. This latest accolade solidifies HemoSonics’ role as a frontrunner in medical device innovation and strategic marketing.
HexaHealth Closes its Series A of $12 Million to Redefine the Surgical Care Journey Across India
HexaHealth, a leading tech-enabled surgery care platform, has successfully closed its $12 million Series A funding round. The round was led by Orios Venture Partners and 3one4 Capital, with participation from new investors Enzia Ventures and ITI Growth Opportunities Fund, along with existing backers Chiratae Ventures and Omidyar Network India. This milestone funding will accelerate HexaHealth’s mission to reshape how surgical care is delivered and experienced across India.
The new funds will be strategically deployed to drive HexaHealth’s next phase of growth. Key initiatives include expanding into new surgical specialities, entering additional geographies across India, building an AI-powered platform to further personalise and enhance patient care, and strengthening the senior leadership team to accelerate innovation and impact.
To date, HexaHealth has facilitated over 30,000 surgeries across India’s key cities, offering patients not just procedures but peace of mind through compassionate, end-to-end care. In FY25 alone, HexaHealth facilitated nearly 15,000 surgeries, valued at approximately ₹150 crore, and achieved positive contribution margins, signalling strong unit economics. The company is now expanding into new cities, bringing its patient-first approach to millions in need.
“At HexaHealth, we are committed to transforming surgery into a journey of trust, not uncertainty,” said Ankur Gigras, CEO and Co-founder. This fundraise is more than just capital; it’s a vote of confidence in our mission to make quality surgical care a right for every individual, not a privilege. With this investment, we are empowered to scale faster, strengthen our technology, and deepen our human touch, ensuring every patient feels supported, informed, and cared for throughout their surgical experience.”
“The surgery facilitation space is ripe for disruption, and HexaHealth’s relentless execution and patient-first philosophy make them true category leaders,” said Sukhmani Bedi, Partner, Orios VP. “Ankur and his team are creating not just outcomes but real empowerment for patients — a vision that will define healthcare innovation over the next decade.”
Nitya Agarwal from 3one4 Capital added, “HexaHealth is setting a new standard in surgical care by leveraging technology and clinical excellence to deliver consistently superior outcomes. In a healthcare market primed for innovation, their scalable model positions them as a category-defining leader. We are proud to back a team with the vision and execution to drive meaningful, long-term impact.”
By seamlessly integrating advanced technology, clinical expertise, transparent pricing, hospital partnerships, financing solutions, and compassionate support, HexaHealth — founded by Ankur Gigras, Vikas Chauhan, and Dr. Aman Priya Khanna — is shaping the future of surgical care in India. The platform’s holistic approach ensures that every patient’s journey is not only safe and efficient but also grounded in trust and empathy. At HexaHealth, every surgery is more than a medical procedure — it’s a story of courage, hope, and healing. With a patient-first vision at its core, HexaHealth’s journey is only just beginning, with the potential to transform millions of lives across the country.