New law encourages schools to stock epinephrine for allergic reactions
NEW YORK — New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.
Barack Obama signed the School Access to Emergency Epinephrine Act, under which schools could maintain a supply of epinephrine, which is the only first-line treatment for life-threatening allergic reactions, also known as anaphylaxis.
The legislation received praise from Mylan, a drug maker that produces EpiPen, a popular epinephrine injector pen.
"Recent tragedies have reinforced that when anaphylaxis occurs, every minute matters, and immediate access to epinephrine and emergency medical care is crucial," Mylan CEO Heather Bresch said. "The new federal law is a critical step for improving anaphylaxis preparedness in schools. We applaud those who worked tirelessly to make this bill a reality, from Congress, government officials and leading advocacy organizers to parents, caregivers, patients and healthcare professionals."
Onco360 added to limited-distribution network for J&J, Pharmacyclics blood cancer drug
NEW YORK — Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.
Onco360 said Wednesday that it had become part of the network for distributing Imbruvica (ibrutinib) capsules. The announcement came the same day that the Food and Drug Adminsitration announced the approval of Imbruvica (ibrutinib) for mantle cell lymphoma, or MCL.
"As one of the select few specialty pharmacies in the network, Onco360 is very proud to have been chosen by Pharmacyclics and Janssen Biotech," Onco360 CEO Burt Zweigenhaft said, referring to the J&J subsidiary that co-markets Imbruvica.
Limited-distribution networks are set up by drug companies in order to control the distribution of drugs, usually specialty drugs that are distributed only to a few select specialty pharmacies. While their purpose is to ensure more efficient production, distribution and use of the drugs, they also often exclude retail pharmacies.
FDA approves Imbruvica for mantle cell lymphoma
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.
The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals’ Velcade (bortezomib) and Celgene’s Revlimid (lenalidomide) are also approved for treating MCL.
Imbruvica is the second drug with the FDA’s breakthrough therapy designation to receive approval from the agency. The FDA Safety and Innovation Act, passed in July 2012, gave the agency the ability to designate a drug a breakthrough therapy at the request of the company seeking approval if preliminary clinical evidence indicates it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Genentech’s Gazyva (obinutuzumab), for chronic lymphocytic leukemia, was the first designated breakthrough therapy to receive FDA approval, earlier this month.
"Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program."