Health ministry asked to examine coronary stent safety concerns

Cabinet secretariat has directed the Union health ministry to investigate safety issues related to coronary stents. These concerns were raised by Rajya Sabha member Ajeet Madhavrao Gopchade regarding models withdrawn in Sri Lanka. Gopchade emphasized the need for strengthening India's regulatory framework for coronary stents. He called for improved clinical documentation and robust traceability for implanted stents. His representation highlighted the importance of patient follow-up and monitoring of device-related complications.

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Biocon clears path for cancer drug launch

Biocon has finalized a global settlement and license agreement with Genentech for its drug Pebrilzo. This agreement addresses all ongoing legal disputes between the two companies in jurisdictions such as the US and Canada. Under the terms, Biocon can launch Pebrilzo in the EU and UK by early 2027 and in the US by Q3 of 2028. Other global launches are planned between 2026 and 2028, depending on regulatory approvals.

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NMC Healthcare founder BR Shetty files $15 billion lawsuit against Bank of Baroda

The suit, filed in the Bombay High Court, seeks $5 billion in direct damages for alleged fraud and negligence, $5 billion in consequential damages and $5 billion in compensation for reputational harm arising from various actions taken by the bank, including a lookout circular issued against him.

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Biocon founder Kiran Mazumdar Shaw says India must shift pharma industry from generics to innovation-led growth

Kiran Mazumdar-Shaw emphasized the importance of building an innovation-driven pharmaceutical industry in India. She highlighted the need for continued investment in research and regulatory reforms to enhance drug development. The industry must focus on maintaining high-quality standards as it seeks to innovate. Closer cooperation between industry and regulators can help sustain momentum during this transition. India has the potential to participate actively in the global innovation ecosystem.

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Zydus moves closer to US market for Keytruda biosimilar as FDA accepts application

Zydus Lifesciences has received acceptance for its application regarding the biosimilar of Keytruda, which is a major cancer drug. The USFDA is expected to complete its review process by the third quarter of 2027. This biosimilar, named FYB206, was developed without a comparative Phase III efficacy trial. Zydus aims to make effective treatments more accessible in the oncology field in North America.

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Panel to finalise cancer drugs for 30% trade margin cap; Rs 2,500 crore annual savings possible

An expert group is finalizing the list of cancer medicines for a new trade margin cap. The government plans to implement a 30% cap to reduce drug prices and save patients money. Retail prices of some anti-cancer drugs could drop by up to 70% as a result of this cap. The trade margin rationalisation will apply to all cancer medicines, including branded and generic versions.

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Supreme Court questions govt over drug pricing, asks why cap limited to anti-cancer medicines

The Supreme Court expressed its worry over the government's restriction of price control measures to only anti-cancer drugs, questioning why other vital medications lack similar oversight when sold at exorbitant rates. The Solicitor General emphasized the importance of maintaining a balance between drug availability and market dynamics in determining prices.

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