Healthcare Reform Legislation Coming Into Focus

After months of behind the scenes negotiations, healthcare reform efforts in Washington DC are starting to come into focus. While legislation has yet to be formally introduced, the President and congressional leaders have been working with stakeholders since January.

While most legislators agree on the need for reform that increases access, maintains quality and lowers costs, how that goal should be accomplished and paid for remains very contentious. The most controversial proposals includes the creation of a public option that would allow individuals to buy into a government run healthcare plan, and include a pathway for approval of follow-on biologics. Both proposals could have potentially unintended consequences on California’s life sciences research and development.

MDMA's Washington Update

Senate Confirms Sebelius and Hamburg

The Senate confirmed Kathleen Sebelius as Secretary of Health and Human Services. Ms. Sebelius was confirmed by a final vote of 65-31, with eight Republicans voting for her confirmation. She now takes control of the Agency as Congress and the President begin their efforts for broad-based health care reform.

The Senate also confirmed Dr. Margaret Hamburg as the 21st Commissioner of the Food and Drug Administration. Dr. Hamburg replaces Acting Commissioner Josh Sharfstein, who will now take the role of Deputy Commissioner. Hamburg received widespread support in the Senate and was approved by voice vote.

M&A: Prepare to speed date

Tips to improve your M&A readiness

By Mike Rose

For many emerging biotech companies, there’s no place to go but mergers and acquisitions (M&A) for funding. And, for the M&A courting process, there are many simple, yet often overlooked, finance and accounting items that target firms commonly overlook that can help bring resolution.

I think of these basic steps as being “M&A ready,” and they are the way to go for any young enterprise looking to do a deal. They help speed up the dating process and are something along the lines of today’s speed dating concept for busy professional singles.

The upside of the public discussion over the American Recovery and Reinvestment Act (ARRA) is that the President’s pledge of transparency is being played out faithfully at the State and Federal levels. The downside – to those in the business of innovation – is that the wisdom of the bets being placed can be so quickly second-guessed.

These bets being placed are plainly visible in California. To their credit, the State has published a map of projects funded by the stimulus package. What is disproportionately clear at first and extended glance, however, is that the State’s top priority is overwhelmingly transportation.

• ACME Bioscience
• Actelion Pharmaceuticals US, Inc.
• Eiger Biopharmaceuticals, Inc.
• ERA Consulting
• IRIX Pharmaceuticals, Inc.
• Lonza, Inc.
• Novo Nordisk Inc.
• SEA Medical Systems, Inc.
• Sitrick And Company, Inc.

• FDA Ups The Ante In Enforcement; Industry Wants Fair Play
  (The Pink Sheet)
• Onyx Accuses Bayer of a Double-Cross Over a Compound Related to Nexavar
  (The Pink Sheet)
• Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules
  (PharmAsia News)
• Vanda's Atypical Approval: Is it Time to Rethink Attitudes Toward FDA?
  (The RPM Report)
• New Stem Cell Therapies (Start-Up)