Pharmaceuticals Posts

India Flexes Its Muscles against Big Pharma

India Flexes Its Muscles against Big Pharma

Mark Crawford

Outsourcing to India is one thing; getting patent protection is another. Big pharma is entrenched in several high-profile cases in the Indian court system, including:

  • Bayer’s challenge to a decision by the patent office that forces it to license its drug, Nexavar, to an Indian firm
  • The patent office revoked Roche’s patent for Valcyte, which the company is appealing
  • India rejected two patent applications by Gilead for its HIV drug Viread; the case is under appeal
  • In 2006 India refused to grant Novartis a patent for its leukemia drug Glivec—Novartis is now challenging that decision in court

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As Pharma Cuts Back, CROs Do More

Mark Crawford

Reacting to market and regulatory forces, pharmaceutical science continues to adapt and survive.Years of downsizing and reduced R&D budgets, combined with the “patent cliff” that many large pharmaceutical companies are facing, have resulted in tens of thousands of layoffs, flooding the job market and creating aftershocks felt throughout the industry. Regulatory changes are also hitting hard. New FDA requirements, especially those focusing on long-term studies, have lengthened internal development timelines and increased costs. The overall effects of these changes are reduced drug applications and less innovation, with fewer products in the pipeline. (more…)