Weekender 5/1/15

To Our New Jersey Life Sciences Community:

Welcome to another edition of The Weekender.

A Pair of FDA Approvals for New Jersey:
The Medicines Company announced that they have received FDA approval for IONSYS (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital. In addition, they also received approval for RAPLIXA (Fibrin Sealant), the first and only powdered fibrin sealant ready-to-use for mild to moderate surgical bleeding. Congratulations to TheMedCo on two approvals in one week!

PTC Therapeutics Testifies on BIO’s Behalf:
Shane Kovacs, CFO of PTC Therapeutics, testified on April 29 on behalf of BIO at the House Subcommittee on Capital Markets and Government Sponsored Enterprises on legislative proposals to enhance capital formation and reduce regulatory burdens.

21st Century Cures Initative Discussion Draft Released:
On Wednesday, leaders of the House Energy and Commerce Committee unveiled a long-awaited draft of legislation that would speed up the approval of new drugs and treatments. While there are some unresolved issues in the draft, BioNJ is encouraged by calls for increased NIH funding, expedited approval processes for drugs that receive a breakthrough therapy designation and improved scientific access and outreach at FDA.

The Introduction of Senate Patent Reform Legislation:
Earlier this week, the Biotechnology Industry Organization (BIO) issued a statement regarding the introduction of The Protecting American Talent and Entrepreneurship (PATENT) Act introduced by the Senate Judiciary Committee. Patent reform is a major issue for BioNJ Members as research is at the heart of the life sciences industry. BioNJ continues to work closely with BIO on the development of the PATENT Act and will communicate updates as we receive them.

Congratulations to Rutgers for this Excellent Achievement:
Rutgers Business School has been recognized as one of the Top 5 destinations in the world to pursue an MBA in Healthcare/Pharma by MBA-Universe.com, India’s No. 1 MBA Portal. Congratulations to Rutgers for this recognition!

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