Weekender 7/15/16


A big legislative win — G.M.O. Labeling Bill gains House approval.
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Welcome to this week’s edition of the BioLines Weekender filled with stories of hope for patients around the globe. Delivering life-changing therapies and cures, New Jersey’s medical innovation and drug development and commercialization capabilities are enabling longer and better quality lives, in turn, reducing the overall costs of healthcare. We couldn’t be prouder.

Here is a sampling of some of the stories you’ll find below…

This week we celebrate a pair of approvals. The European Commission has approved BioNJ Member Celgene’s top seller Revlimid (lenalidomide) for relapsed/refractory mantle cell lymphoma, a rare subtype of non-Hodgkin’s lymphoma that is very resistant to treatment. And, BioNJ Member Novartis and Genentech’s Xolair, or omalizumab, has received expanded approval from the FDA for the treatment of moderate to severe persistent asthma in patients 6 to 11 years old who have in vitro reactivity or a positive skin test to airborne allergens and whose symptoms are sufficiently managed using corticosteroids.

Congratulations to long-time BioNJ Member and dedicated volunteer Dr. Zvi Loewy whose FDA-approved one-step glucose tester will help millions of diabetics.

Meanwhile BioNJ Member Amicus Therapeutics has expanded its biologics pipeline with a potential first-in-class protein replacement therapy for cyclin-dependent kinase-like 5 (CDKL5) deficiency, a rare and devastating genetic neurological disease with no approved treatments.

Enrollment has opened in BioNJ Member Celldex Therapeutics‘ Phase 1/2 study of CDX-014 in advanced renal cell carcinoma. CDX-014 is a novel antibody-drug conjugate that targets the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1).

The FDA has granted a fourth Breakthrough Therapy Designation for BioNJ Member Janssen Research & Development’s ibrutinib (IMBRUVICA®) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

Forbes released its list of the best colleges in the country for 2016 and once again gave high marks to BioNJ Member Princeton University, placing it within the top three colleges in the nation ahead of Harvard University.

Talent is just one of the many reasons companies choose New Jersey to call home… Welcome Brainsway USA Inc., a company focused on the treatment of brain disorders, as the newest member to our life sciences community. Brainsway USA relocated its U.S. headquarters from Philadelphia to Hackensack.

Lastly, in a blockbuster acquisition, Hoffmann-La Roche’s 116-acre former North American Headquarters campus spanning the Township of Nutley and City of Clifton is being acquired and will be redeveloped featuring urbanist living. The most exciting news of all on that front is that Hackensack Meridian Health and Seton Hall University will lease two major buildings and 16 acres at the property.  for details.

Please join us at a future BioNJ event. Visit www.BioNJ.org for our complete calendar. And, make sure you are on BioNJ’s mailing list to receive our latest news and industry updates. Contact Randi Bromberg at RBromberg@BioNJ.org if you are not receiving our emails.

Click here to read this week’s Weekender.