Welcome to another edition of the Weekender.
BIG News for New Jersey Drug Approvals This Week
BioNJ Member The Medicines Company announced the approval of KENGREAL™ (cangrelor) by the FDA as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor (GPI). This is the third approval for The Medicines Company this year!
Eisai Inc. has received approval from the FDA for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa® (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
European regulators have issued a green light for BioNJ Member Bristol-Myers Squibb‘s Opdivo as a treatment for advanced skin cancer, making it the first PD-1 inhibitor to win approval in the region.
Biosimilars Legislation Passes the Senate
Legislation on biosimilar products passed the Senate unanimously on Thursday, June 25. The pending legislation allows some biosimilars to be substituted for biological products, but only if the FDA has approved them as interchangeable with the innovator product. Additionally, pharmacists must notify prescribing physicians of the substitution. This legislation — over a year in the making — represents a thoughtful, balanced approach to providing new medicines while protecting patient safety. Passage of this bill and its signing into law by the Governor will bring new hope to the thousands of patients and their families who are waiting for new treatments and cures.
It’s an Exciting Time to Be Involved in Biotech in New Jersey
BIO 2015 Closes in Philadelphia With More Than 15,800 Attendees
BioNJ would like to thank the Biotechnology Innovation Organization (BIO), Choose New Jersey and the State of New Jersey for an amazing partnership, as well as New Jersey’s Host Committee for all of your hard work and incredible collaboration in making BIO 2015 a HUGE SUCCESS for the entire region. Click here for the list of 179 Host Committee Members from New Jersey. And, click here for the BIO 2015 New Jersey Recap and Wrap Up.
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