FDA approves Pfizer drug as rare lung disease treatment
SILVER SPRING, Md. — The Food and Drug Administration Friday announced that it had approved Rapamune (sirolimus), distributed by Pfizer’s Wyeth Pharmaceuticals, as a treatment for the rare lung disease lymphangioleiomyomatosis (LAM).
Rapamune — which can be a table or oral solution — has been distributed since 1999, used primarily as an anti-rejection drug in kidney transplant patients. Recently, though, it was granted breakthrough therapy and orphan product designation by the FDA — the latter is given to drugs that treat rare diseases. Rapamune was given priority review for its use treating LAM and clinical trials were funded in part by money from the FDA’s Orphan Products Grant Program.
“Different FDA programs, such as orphan product designation and breakthrough therapy designation, provide sponsors with financial incentives and access to increased interactions and advice from FDA to facilitate development and timely approval of innovative treatments for rare diseases, which might not otherwise be developed,” director of the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs director John Jenkins, said. “These kinds of special programs make it possible for FDA to help drug manufacturers get life-saving drugs to the people who need them much more quickly.”
LAM affects about 2 to 5 women per million in the world, whose lung tissues are invaded by an abnormal growth of smooth muscle cells that limits the oxygen delivered to the body.
Teva launches generic Lomedia 24 Fe birth control
BY DSN STAFF
JERUSALEM — Teva on Friday announced that it would be rolling out Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fulmate tablets, 75 mg), a generic version of Lomedia 24 Fe birth control bills.
With the addition of Junel Fe 24, Teva’s line of generic contraceptives expands to nearly 30 offerings.
Walgreens Boots Alliance chief information officer steps down
BY DSN STAFF
DEERFIELD, Ill. – Walgreens Boots Alliance on Friday announced that Tim Theriault, EVP, global chief information officer, will step down, effective June 1, for personal reasons. Theriault will continue to serve as a consultant to the company and as a senior advisor to executive vice chairman and acting CEO Stefano Pessina on a range of issues, including cyber security.
Anthony Roberts, who had served as SVP, international CIO, will now assume the role of Walgreens Boots Alliance SVP, global CIO.
“Tim has played a critically important role over the past six years leading Walgreens IT transformation, and advancing and integrating the Walgreens Boots Alliance technology teams and infrastructure since the merger of Walgreens and Alliance Boots last December," Pessina said. "We are grateful for all that Tim has done and for continuing as a consultant and a senior advisor to me as we pursue new global frontiers in IT to serve customers, patients and partners.”
Roberts brings extensive experience as an IT professional to his new role, having worked for international companies throughout his career including PepsiCo and UPS. In addition, he has led the transformation of IT across Alliance Boots and most recently co-led the integration office in preparation for the merger of Walgreens and Alliance Boots.
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