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Lupin Partners With Tenpoint to Bring YUVEZZI Eye Drops to European Markets

Indian pharmaceutical giant Lupin Limited has struck a licensing deal that will let its subsidiary VISUfarma B.V. sell YUVEZZI™, a presbyopia eye drop, across the European Union, the UK, Switzerland, Norway, and Iceland. The agreement, signed with Visus Therapeutics (a Tenpoint Therapeutics subsidiary), hands VISUfarma exclusive control over regulatory filings, marketing, and distribution of the product in these territories.

YUVEZZI combines carbachol and brimonidine tartrate in a single daily drop — the only approved treatment of its kind for presbyopia, the age-related decline in near vision that typically sets in around age 45. The drug works by keeping the pupil constricted just enough to sharpen close-up focus without over-dilating.

Financially, VISUfarma will make a direct investment in Visus, while Tenpoint and Visus stand to earn milestone payments and sales-based royalties as the drug rolls out.

Lupin CEO Vinita Gupta framed the deal as a natural extension of the company’s earlier VISUfarma acquisition, calling it a step toward strengthening the firm’s European eye-care footprint. Tenpoint CEO Henric Bjarke echoed that sentiment, pointing to VISUfarma’s established presence in ophthalmology as the reason for choosing Lupin as a partner.

YUVEZZI already has U.S. FDA approval, and Tenpoint has filed for UK authorization through the MHRA’s International Recognition Procedure, with further regional applications planned. Presbyopia affects roughly 2 billion people worldwide, making it one of the largest untapped markets in vision care.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Charles River and Medigen Partner to Advance Next-Generation Enterovirus Vaccine

 Charles River Laboratories International, Inc. (NYSE: CRL) has entered a collaboration with Taiwan-based Medigen Vaccine Biologics Corp. (MVC) to support development of MVC’s next-generation multivalent enterovirus vaccine. Under the arrangement, Charles River will apply its Next-Generation Sequencing (NGS) platforms to help characterize and validate the virus seed bank underpinning the vaccine candidate, work that feeds directly into Chemistry, Manufacturing, and Controls (CMC) requirements.

MVC brings a track record in enterovirus vaccines to the table: its ENVACGEN Enterovirus 71 vaccine already holds regulatory clearance in both Taiwan and Vietnam. The company is now looking to build on that base with a broader multivalent candidate, and turned to Charles River for expertise spanning virology, non-clinical development, and regulatory strategy to move the program toward IND-enabling studies and eventual global trials.

“We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development,” Kerstin Dolph, Charles River’s Corporate Senior Vice President of Global Manufacturing, said in a statement, adding that the partnership reflects the company’s broader push to combine biologics testing know-how with safety science to help partners hit development milestones.

MVC Chief Executive Officer Leo Lee said the collaboration would help the company build a development process calibrated to international regulatory expectations from the outset, and that MVC intends to extend the relationship to future vaccine programs as it expands its footprint across Southeast Asian markets.

The deal also comes on the heels of Charles River’s acquisition of Pathoquest, a specialist in NGS-based characterization and quality-control testing for biopharmaceuticals, which the company says will sharpen its sequencing capabilities across the drug development pipeline. Beyond the enterovirus program, the two companies indicated they plan to scope out additional joint vaccine initiatives targeting unmet infectious-disease needs.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Ipsen Completes Kartos Therapeutics Acquisition to Boost Late-Stage Oncology Pipeline

Ipsen  has officially completed its acquisition of KartosTherapeutics, a clinical-stage biopharmaceutical company. The transaction integrates navtemadlin, an investigational, first-in-class oral MDM2 inhibitor in Phase 3 clinical development, directly into Ipsen’s expanding oncology and hematologypipeline.

​Navtemadlin is currently being evaluated in the global Phase 3 POIESIS study as an add-on therapy to ruxolitinib in patients with intermediate- and high-risk TP53 wild-type myelofibrosiswho experience a suboptimal response to standard-of-care ruxolitinib alone. Designed to restore natural p53 tumor-suppressor activity, early clinical data suggest that navtemadlinhas the potential to convert suboptimal treatment responses into clinically meaningful and disease-modifying outcomes.

​Myelofibrosis is a rare and severe myeloproliferative neoplasm characterized by progressive bone marrow failure, debilitating symptoms, splenomegaly, and a heightened risk of progression to acute myeloid leukemia (AML). While ruxolitinib serves as the standard first-line treatment, an estimated 50% to 75% of patients discontinue therapy within three years, resulting in a median overall survival of only one to two years following discontinuation. Navtemadlin aims to directly address this substantial therapeutic gap.

​Under the terms of the merger agreement, Ipsen completed the upfront payment of $450 million, with Kartos shareholders eligible for up to $1.3 billion in additional regulatory and sales-based milestones. The transaction is projected to become accretive to Ipsen’s core operating income starting in 2029.

​The completed acquisition positions Ipsen to establish a dedicated franchise in hematologic malignancies while advancing transformative therapies for patients with high unmet medical needs.

Written by: Pragna Biswas

Graphics by; Pramit Hazra

Union Minister Anupriya Patel announced India Must Move from ‘Pharmacy of the World’ to ‘Laboratory of the World

Addressing the third edition of the IIMA Healthcare Summit 2026 on the theme “Advancing AI in Healthcare,” Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers, Smt. Anupriya Patel, stated that India must move beyond being the “Pharmacy of the World” to become the “Laboratory of the World,” powered by research, innovation, and emerging technologies.  

​Speaking at the Indian Institute of Management Ahmedabad (IIMA), the Minister highlighted the country’s historic contributions during the COVID-19 pandemic, supplying vaccines and essential medical supplies to over 200 countries while administering over 2.2 billion domestic doses. Turning to emerging technologies, she emphasized that artificial intelligence (AI) has immense potential to accelerate drug discovery, personalize treatment, and optimize healthcare delivery. However, she stressed that AI adoption must remain human-centered, safe, and privacy-compliant—complementing rather than replacing human clinical judgment.  

​The Minister outlined key national initiatives supporting this vision, including the ₹5,000 crore PRIP (Promotion of Research and Innovation in Pharma-MedTech Sector) Scheme, the ₹10,000 crore Biopharma SHAKTI mission, and the establishment of AI Centres of Excellence at AIIMS New Delhi, PGIMER Chandigarh, and AIIMS Rishikesh.  

​Shri Manoj Joshi, Secretary, Department of Pharmaceuticals, discussed how Indian startups are utilizing AI to shorten drug discovery timelines and announced that the Government is working to provide financial support to eligible startups for software licensing and operational costs. Smt. Punya SalilaSrivastava, Secretary, Department of Health & Family Welfare, highlighted digital health integration through the AyushmanBharat Digital Mission (ABDM), noting that over 96 crore ABHA IDs and 1,000 crore health records have been linked to date.  

​During the summit, the India Pharma Archives—a digital living archive developed by the Indian Pharmaceutical Alliance (IPA) and IIMA Archives—and a book documenting India’s COVID-19 vaccine journey were officially unveiled .

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Sekhmet Pharmaventures Inaugurates Expanded Manufacturing Block at Unit 6 in Chennai

Sekhmet Pharmaventures has officially inaugurated its newly expanded manufacturing block at Unit 6, Chennai (Anjan Drug Private Limited). The expansion represents a key milestone in strengthening the company’s active pharmaceutical ingredient (API) and contract development and manufacturing organization (CDMO) capabilities.

​With the operationalization of this expanded block, the unit’s overall manufacturing capacity has nearly doubled. The enhanced output is positioned to support surging client and business requirements while driving local economic value through the generation of new employment opportunities and technical talent development in the region.

​The Chennai inauguration marks Sekhmet Pharmaventures’ second major facility expansion completed within the last three months. Continuing this aggressive growth trajectory, the company confirmed that it is on track to inaugurate a third facility expansion by the end of September 2026.

​”As we move forward with our growth plans, we remain committed to investing in infrastructure, people, and capabilities that help us build a stronger and sustainable future,” the company noted.

​The capacity addition reinforces Sekhmet Pharmaventures’ ongoing strategy to scale its core manufacturing infrastructure, improve supply security, and meet rising domestic and international pharmaceutical demand.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

First Autonomous Blood-Draw Robot Gets FDA Authorization

The U.S. Food and Drug Administration has given the green light to Aletta, a groundbreaking robotic system capable of performing blood draws entirely on its own — marking the first time regulators have approved a fully autonomous venipuncture device for real-world clinical use.

Built by Vitestro, the machine relies on a combination of near-infrared imaging and Doppler ultrasound technology to pinpoint a viable vein in a patient’s arm while distinguishing it from nearby arteries. Once a session begins, Aletta independently manages the entire procedure — securing a tourniquet, sterilizing the injection site, inserting the needle, swapping out sample tubes, and finishing with a bandage — all without a technician’s hands touching the patient.

Safety remains built into the design: the unit continually sanitizes the skin throughout scanning, and if a patient shifts position unexpectedly, the needle disengages automatically and the process halts. Sensors are also programmed to flag irregular conditions and pause operation until a supervising phlebotomist intervenes.

Regulators cleared the device for outpatient use in adults, requiring that a certified phlebotomist remain present to launch each session and stay available throughout. Notably, one supervisor can watch over as many as three Aletta units running simultaneously — a feature health officials say could meaningfully ease staffing pressures in an industry currently facing a phlebotomist shortfall.

FDA officials noted that clinical trial results showed the robot’s draw success rate held up against — and in some cases surpassed — that of experienced human phlebotomists, with side effects reported as both rare and minor. The agency framed the approval as part of its broader push to expand access to essential diagnostic services through innovative medical technology.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Jubilant Ingrevia Enters Electronics Sector with ₹189.2 Crore Stake in Zettaone Technologies

Jubilant Ingrevia Limited has announced a strategic move to diversify its business portfolio by acquiring a 40% equity stake in Zettaone Technologies for ₹189.2 crore.

The strategic investment marks Jubilant Ingrevia’s formal entry into the high-growth Electronics Development and Manufacturing Services (EDMS) sector. The expansion comes at a pivotal time when India is rapidly accelerating the development of a robust domestic ecosystem for electronics and semiconductor manufacturing.

Through this transaction, Jubilant Ingrevia aims to gain direct exposure to emerging, high-potential technology opportunities by leveraging Zettaone Technologies’ proven capabilities in electronics design, engineering, and manufacturing. The initiative aligns with the company’s broader strategic vision of expanding beyond its traditional operating domains to build diversified revenue streams in high-demand technological industries.

With the rising nationwide push for advanced domestic electronics and local supply chain resilience, the partnership is set to unlock substantial growth synergies and actively contribute to strengthening India’s manufacturing infrastructure.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Union Health Ministry Proposes Inclusion of Four Drugs Under Schedule H1 to Tighten Regulatory Oversight

The Ministry of Health and Family Welfare (MoHFW), Department of Health and Family Welfare, has issued a draft gazette notification (G.S.R. 745(E)) proposing the inclusion of four widely used medications under Schedule H1 of the Drugs Rules, 1945. The move aims to enforce tighter prescription monitoring and prevent misuse of these substances across the country.

The draft proposal, formulated after formal consultation with the Drugs Technical Advisory Board (DTAB), proposes to insert the following substances under Schedule H1 after entry serial number 52:Flupentixol (Entry 53);Zopiclone(Entry 54);Gabapentin(Entry 55); and Carisprodol (Entry 56)

Schedule H1 drugs are subject to stringent sales and distribution regulations. Under these compliance rules, chemists and pharmacists are mandated to sell these medicines strictly against a valid registered medical practitioner’s prescription. Additionally, pharmacies must maintain a dedicated register documenting the patient’s name, doctor’s details, date of supply, and quantity dispensed, retaining these records for a minimum of three years for regulatory inspection.

The Central Government has opened the draft rules for a 30-day public consultation window from the date of gazette publication. Objections and suggestions from stakeholders, industry representatives, and the general public can be addressed to the Under Secretary (Drugs), MoHFW, New Delhi, or submitted via email to drugsdiv-mohfw@gov.in.

Once finalized, the amended rules will come into force after 180 days from their publication in the Official Gazette, giving manufacturers, distributors, and retailers time to align packaging labels and documentation practices with Schedule H1 compliance norms.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Amylyx Pharmaceuticals Announces Positive Phase 3 Trial Results for Avexitide, for Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals has announced positive top-line results from its pivotal Phase 3 LUCIDITY trial evaluating avexitide, a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist being developed for the treatment of post-bariatric hypoglycemia (PBH).

In the Phase 3 LUCIDITY study, avexitide successfully met its primary endpoint, reducing the rate of Level 2 and Level 3 (severe) hypoglycemic events by 55%compared to placebo. The investigational therapy also demonstrated statistical significance across all key secondary endpoints, offering clinically meaningful control over severe blood glucose drops.

Post-bariatric hypoglycemia is a rare, debilitating complication that can develop following bariatric surgery. In individuals with PBH, meals trigger an exaggerated GLP-1 surge, driving excessive insulin secretion that leads to recurrent, unpredictable, and dangerously low blood glucose levels. Unlike widely known GLP-1 receptor agonists designed to stimulate GLP-1 activity, avexitide is engineered specifically to block the GLP-1 receptor, countering the overactive hormonal cascade at its source.

Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies available for patients suffering from post-bariatric hypoglycemia.

Based on the robust efficacy and safety profile demonstrated in the Phase 3 LUCIDITY trial, Amylyx plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, aiming to bring the first targeted therapeutic option to individuals living with PBH.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Merck & Moderna’s Personalized mRNA Cancer Vaccine Succeeds in Phase 3 Melanoma Trial

Pharmaceutical giants Merck and Modernarevealed encouraging results from their Phase 3 INTerpath-001 study, testing an individualized mRNA cancer vaccine alongside Merck’s immunotherapy drug Keytruda in melanoma patients.

The trial focused on people who had surgically removed stage IIB through IV melanoma tumors. Patients receiving the experimental vaccine—known as intismeran autogene—combined with Keytruda showed meaningfully better outcomes than those given Keytruda by itself, both in staying cancer-free and avoiding metastasis to distant body parts.

Notably, this marks the first time any individualized neoantigen therapy has succeeded in late-stage testing, and the first mRNA cancer treatment to clear this hurdle. It’s also the first study proving a treatment can outperform Keytruda alone as follow-up care after melanoma surgery.

The vaccine works by analyzing each patient’s unique tumor DNA to identify specific mutations, then building a custom mRNA formula that trains the immune system to hunt down those particular cancer cells—essentially a personalized cancer-fighting blueprint.

Safety data from the trial aligned with results seen in earlier studies, with no unexpected concerns emerging. Researchers will continue monitoring participants to assess overall survival rates going forward.

Company leaders called the findings a turning point for melanoma care. Moderna’s CEO noted the milestone represents years of work toward making truly personalized cancer treatment a practical reality rather than a distant goal.

Both companies now plan to share these results at a major medical conference and begin conversations with health regulators about potential approval pathways. The study enrolled over 1,100 patients globally and forms part of a broader research program testing this vaccine technology across nine active trials spanning several cancer types, including lung, bladder, and kidney cancers.

Written By: Sayan Das 

Graphics By: Pramit Hazra