Blog Archives
Top 5 News Stories 7/9-7/13
1. MassBio Commends Governor, Lawmakers for Ensuring Patient Access, Physician Education
MassBio applauded Governor Patrick and the state legislature for including provisions in the Fiscal Year 2013 budget that allow Massachusetts residents to take advantage of co-payment assistance programs and ensure appropriate relationships between industry and providers.
2. Obama Signs FDA Bill Tying User Fees to Reforms
President Barack Obama Monday signed into law the bipartisan FDA bill that sailed through both chambers of Congress last month—a measure that includes a fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V), and provisions that expand the categories of drugs for which the agency will allow faster reviews and decisions.
3. Harvard and Janssen team up on deal worth up to $300M
The Harvard University lab of Douglas Melton has entered into a diabetes partnership with Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. and German biotechnology company Evotec. It could be worth up to $300 million if an approved diabetes drug results from the deal. The deal includes an upfront payment of $8 million and proceeds will be shared between Harvard and Evotec.
Policy Brief: PDUFA Update
BREAKING NEWS: HOUSE PASSES PDUFA
The reauthorization of PDUFA V would be good for industry, good for the FDA, and, most importantly, good for patients.
We wrote back in February about how MassBio was working with our member companies, BIO and the Massachusetts delegation to advocate for the prompt reauthorization of PDUFA this session. Today, we’re pleased to share that versions of this bipartisan bill have now passed in both the Senate and the House.
Last week, on the Senate side, there overwhelming passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthorization of the Prescription Drug User Fee Act (PDUFA). We applaud Senators Kerry & Brown for their work and leadership on this issue (read more here).
Just yesterday, the House approved user fee legislation that includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) (read more here).
What’s next?
The Campaign for Modern Medicines explains the next steps of PDUFA:
Over the next few weeks, the Senate and the House will now come together in a conference committee to combine the House and Senate versions of PDUFA into a final bill. Multiple members of Congress have expressed their desire to pass PDUFA by July 4th, and we hope that the conference committee will adhere to that deadline. Reauthorizing PDUFA well before it is set to expire at the end of September will ensure that the FDA’s review of new drugs is not interrupted, and that patients access to cutting-edge treatments is not delayed. (Link.)
What does PDUFA V include?
Click here for BIO’s summary of key PDUFA V improvements & recommendations.
Top 5 News Stories 5/18-5/25
BREAKING NEWS: SENATE PASSES PDUFA:
MassBio Applauds Senators Kerry & Brown for Work on Passage of User Fee Package Link
1. Coughlin and Anderson: Bridging the state’s skills gap MetroWest Daily News – 5/18/12
A study released last month by the UMass Mass BenchMarks program revealed what many already sensed: the Bay State economy is picking up steam, growing at a rate of 4.5 percent, twice the national rate. Link
2. Three life sciences businesses among BBJ’s top 10 Mass High Tech – 5/18/12
On Friday, the Boston Business Journal Research Department published the BBJ 150, a list of the top 150 public companies in Massachusetts, ranked by 2011 revenue. Link
3. Former Secretaries Rubin, Paulson to speak at BIO Mass High Tech – 5/21/12
Former Secretaries of the Treasury Robert E. Rubin and Henry M. Paulson, Jr. will be in Boston June 19 to speak on a panel at the national Biotechnology Industry Organization annual meeting, called the BIO International Convention. The two will discuss the state of the global economy in a lunchtime keynote panel, moderated by BIO President and CEO Jim Greenwood, the organization said. Link
