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ON-DEMAND INSIGHTS

Negotiating a "Win-Win" in Pharmaceutical Contact Manufacturing

March 7, 2019 at 9:47 AM - Life Sciences,

    

In an earlier post, we explored some of the key issues in a contract manufacturing agreement from the perspective of the drug developer. However, Outside GC frequently represents outsourced manufacturers, too. The knowledge we’ve gained from working on both sides of the table enables us to effectively and efficiently negotiate agreements that satisfy both parties.

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The Changing Landscape for Off-Label Promotion

April 19, 2016 at 2:52 PM - Life Sciences

    

 

Imagine your child or spouse is suffering from an illness with few effective treatment options, such as a rare pediatric cancer or autoimmune disease. Meanwhile, a team of doctors and researchers has been steadily working to unlock the mysteries of this disease for years, in an ongoing effort to identify better solutions for patients.  The team has just published promising results from a recent study in a respected medical journal. The study involved so-called “off-label use” of a prescription drug for these patients, i.e. administering a drug already approved by FDA, on the market, and prescribed by doctors for a related but different medical condition. 

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Contract Manufacturing Agreements for Pharmaceuticals

February 2, 2016 at 1:41 PM - Life Sciences

    
Life sciences companies comprise a sizable component of our overall client portfolio, many of which are engaged in the business of discovering and developing drug products.  As anyone familiar with this industry knows, the road to regulatory approval and commercial entry is complex, lengthy and challenging.  One critical step during the later stages of development is to establish the manufacturing process for the drug candidate.
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Outside GC is an innovative approach to legal services for growing and mature businesses. Companies who engage Outside GC fall into two main categories: (1) those without in-house counsel who need regular, on-going legal support but do not wish to hire a full-time in-house lawyer, and (2) those with in-house counsel who do not wish to add more full-time resources to their existing in-house staff. Contact us to speak to one of our on-demand attorneys.

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