Approval for biologics will not come easy with healthcare reform

With the new healthcare reform, there is an option for biosimilars to be approved for US use. However, due to the complexities of making the similar drug, the FDA will be more rigorous with their approval process, assuring that the generics and original drugs genetic structures are the same. Read the full article at Fierce Pharma here.

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European healthcare cuts benefit biologic makers

According to a recent article at Reuters, the European Pharma industry is looking to its generic segments to profit. Sanofi aventis, Merck, Teva and Astra Zeneca have all indicated that they will look to strengthen their biologics divisions. Read the full article here.

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Quality Safety and Efficacy of Follow-on Biologics

Teruhide Yamaguchi posted this sideshow titled "Quality Safety and Efficacy of Follow-on Biologics." It looks at the state of biosimilars in the EU, US and Japanese markets.


Quality Safety and Efficacy of Follow-on Biologics -

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View the Combination Products Summit Distinguished Speaking Faculty

Hear from these and other distinguished industry leaders at the Combination Products Summit on September 23-24 in Baltimore!

Speaking Faculty includes:
Angela C. Krueger, Regulatory Advisor, CDRH Product Jurisdictional Officer,
Office of Device Evaluation, FDA

John Kinzell, President & CEO,
XERIS PHARMACEUTICALS

Eric Edwards, Co-Founder & Chief Scientist,
INTELLIJECT

Michael Gross, Senior Consultant,
BIOLOGIC CONSULTING GROUP

Asif Sidiqui, Director, Regulatory Affairs,
ROCHE MOLECULAR SYSTEMS

Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs,
GENENTECH

To find out what they will be speaking on and their topics, please visit our webpage.

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Stem cells show promise for hearing loss

A recent study by Dr. Kazuo Oshima from Standford University took two stem cells and used them to regenerate hearing in mice. The stem cells were coaxed into becoming hair cells in the middle ear that are key in the hearing process. Their next step is to try with human cells. Should this work, which Dr. Oshima points out there are still many hurdles to overcome and there are a few years before this could be a viable option. But the study shows success. Read the full article here.

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New White Paper: Helpful Hints for Better Aseptic Technique

Jill Mariano, MD of the Cell Based Assays LinkedIn group recently shared the white paper Helpful Hints for Better Aseptic Technique. You can see the white paper here.


In 2010, we are combining the Cell Based Assays and Bioanalytical Development Conferences to provide one comprehensive event that encompasses both areas, yet leaving time to dive deeply into the content of each one using separate track sessions. For more information on this event, please visit the webpage.

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Merck shares what it has in store for this year

Merck recently shared what it is working on for the 2010 year and beyond in terms of the drugs they are developing.

They're looking at five new drugs to enter the market this year:

1. Boceprevir,for hepatitis C
2. Janumet XR (sitagliptin/metformin) and NOMAC/E2 (all USA), which is a new diabetes combo
3. MK-0431D, for sitagliptin and simvastatin
4. Ridaforolimus, a sarcoma drug (worldwide)
5. Daptomycin, injectable antibiotic

Noting the new possible pathway for biologics that healthcare reform has provided, Merck currently has five biosimilars in late stage development.

Read the full story here.

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Biosimilars to transform the competition

At Medical, Marketing & Media, they look at how the new approval pathway for biologics will not only increase the marketing for the biosimilars but the biologics as well. Follow-on Biologics will change the shape of the market, as they will be more than just a generic. While biologics will have market exclusivity for 12 years, once a follow-on biologic is on the market, prices for these are only expected to be 20-30% lower.

Do you expect the marketing for biologics to change once they face competition from biosimilars? Read more about this topic at MM&M.

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2nd Annual Value Driven Pharma: New Dates & Venue Announced for 2010

2nd Annual Value-Driven Pharma Conference - SAVE THE DATE!
October 21-22, 2010 Princeton Doubletree • Princeton, NJ

2010 may prove to be the most important year in the history of the pharmaceutical business. With the passage of healthcare reform, the industry must act now to reengineer their market access strategy for future success and sustainable profits. Following the launch of the industry’s premier market access event Value-Driven Pharma in October last year, we are putting the finishing touches on the 2010 agenda.

Value-Driven Pharma 2010 will provide you with the tools to deliver data and information payers want. Explore risk-sharing contracts, the demand for more outcomes data from payers and the requirements around Comparative Effectiveness Research and pave the way for formulary placement from the earliest point possible in the development cycle.

To find out about what's new to this year's event and to sign up for future updates, visit our webpage here.

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Biorepositories 2010 Brochure Ready for Download

The Biorepositories event is back for its 3rd year and we want you back! The 2010 program is ready for you to download. As the industry continues to evolve with increasing interest in personalized medicine, along with novel and emerging technologies, more emphasis is being placed on the value of preserving precious biological samples. Stay current on this growing field in order to significantly impact your future drug development and revenue, and drive forward biospecimen science.

Visit the webpage to find out more about the event:
http://bit.ly/9I2THK

Download the brochure here:
http://bit.ly/9MFl6h

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