Pharmaceutical Posts

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Larry Ferrere, Senior Vice President, Product Strategy & Chief Marketing Officer, Pilgrim Quality Solutions

It’s time to make the move to the cloud. Most businesses are taking advantage of cloud-based applications, private clouds, or cloud data storage on some level. In recent years, the cloud has surged in popularity, and many business are making the move. Early adapters and small businesses view the cloud as a way to reduce IT infrastructure and resource costs, and also as a way of gaining access to technologies that might normally be reserved for larger companies.

Today, businesses are realizing increased benefits from cloud-based technologies beyond just cost savings. For the Pharmaceutical industry, many of the challenges that quality and compliance teams currently face can be simplified by deploying a quality system in the cloud. Let’s take a look at how a cloud-based quality system can propel your compliance efforts to the next level.
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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

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…)