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Sekhmet Pharmaventures Inaugurates Expanded Manufacturing Block at Unit 6 in Chennai

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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

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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

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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

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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

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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

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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

Glenmark Secures U.S. FDA Approval for Flonase®️ Nasal Spray

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Glenmark Secures U.S. FDA Approval for Flonase®️ Nasal Spray

Glenmark Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluticasone Propionate Nasal Spray USP, 0.05 mg (50 mcg)/spray. 

​The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Flonase® Nasal Spray, 0.05 mg/spray, by Haleon US Holdings LLC. The product will be commercialized and distributed across the United States by Glenmark Pharmaceuticals Inc., USA. 

​According to IQVIA™ sales data for the 12-month period ending June 2026, the Flonase® Nasal Spray market achieved annual sales of approximately $295.2 million (including brand and available therapeutic equivalents). 

​”The approval of Fluticasone Propionate Nasal Spray USP marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area,” said Marc Kikuchi, President & Business Head, North America. “We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.” 

​The approval reinforces Glenmark’s continuous focus on expanding its core respiratory pipeline and delivering affordable, high-quality generic therapeutics to the U.S. market.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Chai Discovery Collaborates with Bristol Myers Squibb to Advance AI-Driven Antibody Discovery

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Chai Discovery Collaborates with Bristol Myers Squibb to Advance AI-Driven Antibody Discovery

Chai Discovery has announced a strategic collaboration with Bristol Myers Squibb (BMS) to accelerate AI-powered antibody discovery, moving generative molecular design directly into active drug development workflows.

Under the agreement, Bristol Myers Squibb will leverage Chai Discovery’s advanced molecular folding and generative design models to identify novel antibody candidates across its therapeutic portfolio. The integration allows BMS to incorporate sophisticated generative AI into its early-stage discovery pipelines to target complex disease pathways.

Chai Discovery’s AI foundation models are engineered to generate de novo molecular structures based on defined target criteria. By predicting molecular folding and designing optimized candidates computationally, the technology significantly compresses discovery timelines while unlocking challenging biological targets that conventional drug discovery approaches have historically struggled to address.

By combining Chai’s cutting-edge computational capabilities with Bristol Myers Squibb’s extensive therapeutic expertise and clinical drug development infrastructure, the collaboration aims to pioneer breakthrough therapies and expedite the journey of next-generation antibody medicines into clinical trials.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Massive ₹5 Crore Fake Medicine Scam Uncovered Near Bengaluru

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Massive ₹5 Crore Fake Medicine Scam Uncovered Near Bengaluru

The Drug Enforcement Wing of Karnataka’s Food Safety and Drugs Administration (FSDA), in coordination with local police, has busted a major counterfeit pharmaceutical operation running inside an unlicensed farmhouse near the Bidadi toll gate in Ramanagara district. Authorities seized spurious, relabelled, and expired medicines alongside industrial packaging equipment valued at approximately ₹4.91 crore. Four individuals have been arrested in connection with the racket.

​Acting on specific intelligence, enforcement officers raided the farmhouse premises in Kurubara Karenahalli, where operators were allegedly procuring lower-cost pharmaceuticals from manufacturing units in Himachal Pradesh and Telangana. The drugs were subsequently transferred into fresh vials, stamped with forged labels, and repackaged to mimic high-value multinational and imported pharmaceutical brands,includingPfizer before being sold at inflated prices.

​Among the seized items were 5,640 vials of CEFIAVIGENT 2.5 1 Injection (valued at ₹3.38 crore), 1,531 vials of HIZLAM Injectables (₹52.24 lakh), 470 vials of Xavitaz injection (₹27.49 lakh), 264 vials of EMBLAVEO (₹20.59 lakh), and 30 boxes of expired medicines worth ₹35 lakh. Critical-care and ICU broad-spectrum injectable antibiotics were recovered during the bust. Officers also confiscated injection-filling machinery, vial caps, rubber stoppers, forged stamps, and counterfeit labels with non-functional QR codes.

​According to officials, the operation was running without any valid drug manufacturing or distribution licenses, violating key provisions of the Drugs and Cosmetics Act, 1940. An FIR has been registered at the Tavarekere Police Station. Authorities are blocking all associated batch numbers on the state FDA portal and sending drug samples for rigorous laboratory analysis to determine chemical composition, potency, and sterility while tracing downstream supply networks to protect patient safety.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Avalon Pharma and Bio-Thera Execute Exclusive Commercialization Agreement for BAT2406 in MENA

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Avalon Pharma and Bio-Thera Execute Exclusive Commercialization Agreement for BAT2406 in MENA

Avalon Pharma and Bio-Thera Solutions, Ltd. announced an exclusive licensing and commercialization agreement for BAT2406, a proposed biosimilar referencing Dupixent® (dupilumab), across Saudi Arabia and the broader Middle East and North Africa (MENA) region.

Under the 15-year agreement, Bio-Thera will oversee the clinical development, manufacturing, and commercial supply of BAT2406. Avalon Pharma secures exclusive rights to register, market, and distribute the biologic in the MENA region, with plans for potential technology transfer and localized manufacturing in Saudi Arabia. Pending patent expirations and regulatory approvals, commercial launch is slated for 2031 and is projected to generate at least SAR 400 million in cumulative revenue over its first seven years.

BAT2406 targets interleukin-4 receptor alpha (IL-4Rα) to inhibit IL-4 and IL-13 signaling pathways, which drive Type 2 inflammatory conditions such as atopic dermatitis, severe asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.

“This collaboration represents another significant milestone in Avalon Pharma’s journey to becoming a regional leader in specialty pharmaceuticals and biologics,” said Mohamed Maher Al Ghannam, CEO of Avalon Pharma. “Together with Bio-Thera, we are strengthening our presence in immunology while advancing our long-term ambitions for pharmaceutical localization in alignment with Saudi Vision 2030.”

The agreement marks the second biosimilar partnership between the two companies, following their earlier alliance for BAT3306, a proposed biosimilar referencing Keytruda® (pembrolizumab).

Written by: Pragna Biswas

Graphics by: Pramit Hazra

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