Newsletter | June 6, 2019

06.06.19 -- Biosimilars In MENA: What To Know

Featured Editorial
MENA: Biosimilar Market Challenges And Regulatory Considerations
By Anna Rose Welch, editor, Biosimilar Development
Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.
Medicare Negotiation And Competitive Licensing Act: A Challenge To Patents
By Natasha Daughtrey and Khurram Naik, Goodwin Procter LLP

This recent congressional proposal would give Medicare the right to negotiate directly with manufacturers for drug prices. But this proposed bill could also allow the Department of Health and Human Services (HHS) to issue a “competitive license” to another drug manufacturer in certain situations — even if there is patent and regulatory exclusivity protecting the drug.

3 Tips To Advance Biosimilar Education For IBD Patients
By Anna Rose Welch, editor, Biosimilar Development

Whether it be pointing out specific unmet needs in IBD, or suggesting meaningful educational materials for patients, one patient advocate delivered great examples of how manufacturers can support patient advocates and provide them with the information they need most today.

Industry Insights
Translating Data Into Insights With Bioinformatics
White Paper | By Wendell Jones, Ph.D., Q2 Solutions

Learn what bioinformatics offers to precision medicine and immuno-oncology.

How Services Marketers Can Own Their Performance Measures
Article | By Kevin Olson, Industry Standard Research

Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

Speed Biologics To Clinical Trials Faster
E-Book | GE Healthcare Life Sciences

If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.

  GRx+Biosims 2019

Back + better than ever! Join us November 4 to 6, 2019, in North Bethesda, MD, for GRx+Biosims 2019. GRx+Biosims is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy, and legal professionals. Hear from top-in-their-field officials and subject matter experts, share knowledge and best practices, and gain insights on navigating the regulatory process approvals and the evolving policy landscape. Register Today!

ChemiDoc MP Imaging System
Bio-Rad Laboratories, Inc.
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