OneSource Specialty Pharma partners with Formycon AG to manufacture biosimilars

OneSource Specialty Pharma has announced a manufacturing partnership for biosimilars with Formycon AG. This collaboration will see OneSource providing integrated manufacturing capabilities for biosimilars. The partnership aims to expand access to high-quality, affordable biologics for patients globally. Formycon AG CEO stated this strengthens their supply capabilities with a quality-focused partner. Both companies aim to broaden sustainable global access to life-changing biosimilar therapies.

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FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug

The US FDA approved an at-home starting dose for Eisai and Biogen's Alzheimer's drug. This new subcutaneous formulation allows patients to self-administer injections, improving access. Previously, patients received intravenous infusions, typically at clinics, for initial treatment. This approval differentiates Leqembi from competitor Kisunla's infusion-only requirement. The drug targets amyloid beta plaques in the brains of Alzheimer's patients.

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Warburg, Bain, CVC among PE firms in talks to buy into Agappe Diagnostics

Several global private equity firms are exploring a significant stake purchase in Agappe Diagnostics. This potential deal involves both existing investor sales and new capital infusion. The transaction is expected to value the Kochi-based in-vitro diagnostics firm at over three thousand crore rupees. Agappe Diagnostics develops and manufactures diagnostic reagents and equipment for global markets.

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Emcure buys remaining 12.05% in Gennova to take full control

Emcure Pharma is acquiring the remaining stake in Gennova Biopharmaceuticals. This move simplifies ownership and sharpens strategic focus for the subsidiary. Gennova will now be led by Samit Mehta for its next growth phase. The company will continue leveraging its biomanufacturing platforms for new products. Gennova's former CEO Sanjay Singh has divested its mRNA business.

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First vaccine for Bundibugyo Ebola hits human trials in Oxford study

Oxford's Ebola vaccine candidate has entered Phase 1 clinical trials for safety evaluation. The ChAdOx1 BDBV vaccine uses a platform similar to the Covid-19 vaccine. Serum Institute of India manufactured approximately 620,000 doses for potential future use. This initiative builds on a strategic partnership with CEPI and the University of Oxford. Late-stage trials will follow if Phase 1 results prove successful.

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Schedule H1 explained: Why did India tighten its prescription rules for high-alcohol medicines?

Schedule H1 Explained: High-alcohol oral medicines now require a doctor's prescription under Schedule H1. This stricter classification mandates detailed sales records for pharmacies. The government aims to prevent misuse and diversion of these potent preparations. Previously exempt alcohol-based tonics face new licensing and prescription rules. Patients will need valid prescriptions for these medicines moving forward.

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Pharma body renews push for data protection

Leading pharmaceutical companies seek Regulatory Data Protection to boost research investments. Public health groups and local makers oppose this, fearing extended monopolies and delayed generics. The Organization of Pharmaceutical Producers of India argues it benefits indigenous drug makers too. China has already implemented similar clauses, seeing significant research deal growth. India's regulatory alignment with global practices could attract discovery research investments.

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