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Zydus Cadila

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Latest From Zydus Cadila

Patent Rebuff For Roche’s Valcyte In India, Again

Roche’s powder formulation for Valcyte (valganciclovir) has failed to secure a patent in India, at least for now, with the patent office seeing no ‘technical advancement’ in the invention.

Intellectual Property India

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy

Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India

Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.

Policy & Regulation Clinical Trials

Pfizer Pulls Plug On Two Unviable Indian Sites, Over 1,500 Jobs At Risk

Pfizer is ending operations at two Indian manufacturing sites, including one with a checkered regulatory history. Approximately 1,700 jobs are at stake as a result of the action, though the US multinational clarified that it is not making a widespread exit from Indian manufacturing.
Commercial Strategy
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